Clinical Research Directory

CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System

The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery. The primary endpoints are: Effectiveness: Clinical Success, defined as intraoperative anastomosis patency. Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. Participants will receive treatment as standard of care and be asked to: Allow the researchers to access and use their information. If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments. Participants will be asked to comply with the follow-up visits as outlined in the protocol.

Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck.

Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema

Lymphedema occurs not only in patients with breast cancer and gynecological cancers but also in those where lymphatic drainage is obstructed. Accumulation of lymphatic fluid within tissues results in limb swelling. Additionally, proteins present in lymphatic fluid might lead to fibrosis within tissues, causing various challenges for patients. The changes in volume and weight can significantly impact daily life activities such as eating, brushing teeth, and other routine tasks. Furthermore, it can lead to clothing difficulties and provoke unwanted attention due to aesthetic concerns. Currently, there is no definitive treatment for lymphedema. However, prospective research has shown promising results in applying extracorporeal shock wave therapy (ESWT), originally used for musculoskeletal disorders like plantar fasciitis, tennis elbow, frozen shoulder, and non-union fractures, to lymphedema patients. Similarly, Pulse Electromagnetic Field Therapy (PEMFT), widely used for pain management and muscle strengthening, has the potential for treating lymphedema as it can enhance blood circulation and stimulate muscle contractions. This research project aims to explore the effectiveness and sustainability of using ESWT and PEMFT for lymphedema patients. By applying these therapies to lymphedema patients, this study aims to evaluate their treatment outcomes and long-term effects.

Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema

Detecting the Undetected: Heart Failure Screening at the Lymphoedema Point of Care

Heart failure affects more people than the four most common cancers combined. When identified early, management is more straightforward, preventing complications, hospitalisations, and fatalities. Breathlessness and fatigue are cardinal symptoms of heart failure that can present in a number of conditions. As a result, leg swelling, the third cardinal symptom, is the first noted in many people. The presence of leg swelling leads to patients being seen in lymphoedema clinics before the need for cardiology investigation has been identified. Lymphoedema is the presence of chronic oedema as a result of congenital abnormalities, inflammation, infection, trauma, or cancer and its treatments. The vast majority of lymphoedema patients have swelling in their legs. A recent study has shown that 9.4% lymphoedema patients need to be investigated for heart failure. At present, the need for investigation is identified by performing a laboratory blood test, which takes time to arrange and complete. An alternate point of care test can provide a result in 12-minutes at the lymphoedema appointment, and enable appropriate action to be taken. This can reduce the demands on primary care and shorten the chain of events to a specialist assessment, as well as reducing inappropriate referrals. This research, funded by NHS Wales Performance and Improvement, will perform a point of care test to screen for possible heart failure in lymphoedema clinics and establish the clinical utility by exploring the experiences of patients and staff involved and determining the health economic benefits. A supplementary aim is to compare the point of care test to the currently used laboratory test in a subsample to promote confidence in the test and support efforts to spread and scale across all health boards in Wales on completion.

Multimodal Ultrasound for Differentiating Lymphedema and Lipedema

The aim of this observational study is to evaluate the diagnostic value of multimodal ultrasonography in differentiating between lymphedema and lipedema. Differentiating these two chronic conditions based solely on clinical examination can be challenging due to overlapping symptoms. This study will utilize various non-invasive ultrasound techniques-including B-mode ultrasound, strain elastography, power Doppler, and quantitative ImageJ analysis-to compare tissue characteristics among patients with lymphedema, patients with lipedema, and healthy controls. The goal is to identify reliable, non-invasive imaging biomarkers that can facilitate early and accurate diagnosis, thereby optimizing patient management.

Lymphoedema Diagnosis and Treatment

A domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency.

Longitudinal Body Composition Assessment in Breast Cancer Patients

This observational cohort study aims to track longitudinal changes in body composition, including skeletal muscle mass and fat distribution, in patients diagnosed with breast cancer. Following primary surgery and adjuvant therapy, participants will be monitored over a 2-year period. The primary objective is to evaluate the natural progression of skeletal muscle mass index (SMI) and metabolic changes in this population. By conducting serial measurements, this study seeks to characterize the longitudinal trends in muscle loss and body composition shifts post-treatment, providing data to better understand the physiological impact of the cancer recovery process.

Impact of Virtual Reality (VR) Based Exercises on Lower Limb Lymphedema Outcomes (LELO)

This randomized controlled study aims to investigate the effects of virtual reality (VR)-assisted gait training, in addition to Complex Decongestive Therapy (CDT), on gait parameters, physical function, quality of life, and edema levels in patients with lower extremity lymphedema. Lymphedema is a progressive condition characterized by the accumulation of protein-rich fluid due to lymphatic drainage insufficiency, leading to chronic inflammation and fibrosis. It impairs gait patterns and reduces functional mobility. VR technologies, such as the RehaWalk system, provide interactive, personalized rehabilitation environments that enhance motor learning, motivation, and adherence to treatment. The study evaluates spatiotemporal gait parameters, three-zone foot analysis (heel, midfoot, forefoot), limb circumferences, ultrasound measurements (dermis, epidermis, subcutaneous fat thickness), and patient-reported outcomes. VR-based training offers a novel, engaging approach to improve physical rehabilitation outcomes in patients with lower limb lymphedema. No significant risks are expected in this study.

Investigation of the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema.

This study aims to investigate the effect of progressive resistance exercise training on the clinical findings and functional outcomes of lymphedema in individuals who develop upper extremity lymphedema after breast cancer treatment (surgery, chemotherapy and/or radiotherapy).

Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

The purpose of this study is to demonstrate the feasibility of near-infrared fluorescence imaging in subjects with acquired or hereditary lymphedema, in subjects with lipidema and other lymphovascular disorders and in normal health subjects; in order to attempt to correlate imaging phenotype(s) with genotype(s).

PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.

ATI Evidence-based Guide Investigating Clinical Services

The goal of this study is to evaluate how standard-of-care outpatient rehabilitation is delivered and how variation in care delivery mechanisms relates to clinical outcomes, service utilization, and value in patients receiving physical or occupational therapy. The study will focus on patients with musculoskeletal (MSK) conditions receiving physical or occupational therapy. The focus is to use existing standard-of-care documentation in a physical therapy (PT) electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine outpatient PT care, in order to generate evidence to improve clinical effectiveness and quality of care. Researchers will compare different care delivery mechanisms to see if variations lead to significant differences in outcomes. Participants will have their standard-of-care documentation analyzed, including routine clinical measures, objective/functional measures, and patient-reported outcomes. They will not be directly involved in research interventions or randomization. This study does not involve a research intervention, randomization, or alteration of clinical care. It is a retrospective cohort study analyzing existing standard-of-care documentation from ATI's physical therapy EMR. Data are collected via the investigators proprietary electronic medical record system and are synthetic to the clinical process that is, the data are collected in real-time with patients and the scores are immediately provided to the treating therapist as well as archived for later Registry and scientific use.

A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. The primary endpoints are: * Effectiveness- Rate of intraoperative anastomosis patency at first attempt. * Safety- Freedom from device-related adverse events. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a lymphedema procedure, they will be asked to undergo a questionnaire as part of the study. * Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.

Aerobic Training in Lower Extremity Lymphedema

This randomized controlled study aims to evaluate the effects of aerobic exercise training on gait, postural control, lower extremity muscle strength, and functional status in individuals with bilateral lower extremity lymphedema. A total of 24 participants aged between 20 and 60 years with a diagnosis of bilateral lower extremity lymphedema will be randomly assigned to either an aerobic exercise group or a control group. The aerobic exercise group will receive aerobic exercise training in addition to Complex Decongestive Therapy (CDT), while the control group will receive CDT alone. Lower extremity edema will be assessed using circumferential measurements taken from the ankle to the inguinal region. Gait function will be evaluated through angular and spatiotemporal analysis using Kinovea software, including parameters such as step length, walking speed, and double support time. Postural control will be assessed using the Balance Error Scoring System (BESS) and the Timed Up and Go Test. Lower extremity muscle strength and endurance will be evaluated using Manual Muscle Testing and the 30-Second Sit-to-Stand Test. Functional status of the lower extremities will be assessed using the Lower Extremity Functional Scale (LEFS).

Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.

Infant Massage for Lymphedema and Comfort in Preterm Newborns

This randomized controlled trial investigates the effectiveness of infant massage in reducing symptoms of immobilization-related lymphedema and improving comfort in preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU). Preterm infants frequently develop lymphedema due to their immature circulatory systems and prolonged lack of movement. The study compares two groups of infants: one receiving standard care and another receiving a daily 15-minute massage therapy session for 14 consecutive days in addition to standard care. Researchers will evaluate the impact of the massage by measuring the circumference of the infants' wrists, elbows, ankles, and knees to assess fluid reduction. Additionally, the infants' comfort levels will be assessed using the Premature Infant Comfort Scale (PICS). The goal is to determine if massage can serve as a safe, non-invasive method to manage lymphedema and reduce distress in this vulnerable population.

Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)

To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedema/fibrosis.

Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection

The purpose of this study is to find a way to detect a surgical complication, called lymphedema, at an earlier stage. This potential complication may develop in some patients after removal of the armpit lymph nodes (axillary dissection). It is very important to identify this condition as early as possible to improve the treatment options. This study will examine whether or not focused questionnaires are able to identify lymphedema, comparing to physical measurements (like arm circumference).

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

To find out if adding medication can help treat or prevent lymphedema and/or fibrosis related to radiation therapy, in survivors of head and neck cancer. Researchers will compare these drugs to find the most effective therapy for preventing or limiting these side effects.

Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema

Lymphedema is a disorder of the lymphatic vascular system characterized by impaired lymphatic return and swelling of the extremities and accumulation of undrained interstitial fluid/lymph that results in fibrosis and adipose tissue deposition in the affected area. It can be an inherited condition (primary lymphedema) or occurs after cancer surgery and lymph node removal (secondary lymphedema). It causes a significant morbidity and is a common disabling disease affecting more than 200 million people worldwide, however there is no curative treatment for primary or secondary lymphedema.

LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema. Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life

Prospective Screening for Breast Cancer-related Lymphedema

The primary objectives of this study are twofold: 1) to detect and determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arms during and after treatment for breast cancer by collecting patient reported outcome measures, objective measurements, and clinical information in a prospectively maintained database and 2) to improve breast cancer-related lymphedema outcomes by early detection using objective measurements and symptoms assessments and assess these outcomes by maintaining the data in a database in order to contribute to the literature. The secondary aim of this study is to assess extracellular fluid content in the upper extremity, breast, and/or trunk of patients treated for breast cancer before, during, and after treatment in order to better understand the role of bioimpedance spectroscopy in lymphedema screening.

Vascular Lab Resource (VLR) Biorepository

This is a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.