Clinical Research Directory

Single-channel Fibroid Morcellation System Used in Clinical Research on Laparoscopic Myomectomy

This prospective, single-center, randomized, single-blind controlled trial aims to evaluate the efficacy and safety of a novel single-channel retrieval bag compared to a widely used dual-channel retrieval bag in laparoscopic myomectomy. A total of 78 patients aged 18 to 45 years with uterine fibroids (diameter ≥ 4 cm and requiring preservation of the uterus) will be randomly assigned to the experimental group and the control group in a 1:1 ratio. The experimental group will use the single-channel system (an upgraded high-transparency large-capacity retrieval bag + fragmentation device with a fibroid limiter), while the control group will utilize a standard dual-channel bag + fragmentation device with a fibroid limiter. The primary outcome measure will be the total surgical time. Secondary outcome measures will include the success rate of placement, intraoperative leakage rate, surgeon's learning curve, and intraoperative/postoperative complications. Patients will be followed up at 3 months, 6 months, 12 months, and 24 months to assess recurrence and the risk of fibroid dissemination. Preliminary data (n = 22) indicate that the single-channel myomectomy fragmentation system significantly reduced total sampling time (15.4 minutes vs. 36.7 minutes, p = 0.005) while demonstrating comparable safety. This study utilizes the same electric fragmentation device for both the experimental and control groups, with the experimental group employing a further upgraded single-channel retrieval bag to verify the advantages of the novel single-channel retrieval bag in simplifying surgical procedures, improving efficiency, and providing a smoother learning curve, thereby offering evidence for its clinical promotion and patent conversion, particularly suitable for primary care hospitals.

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

This study will test whether gentle electrical stimulation to nerves near the uterus can reduce pelvic pain after uterine fibroid embolization. The investigators hypothesize that participants receiving active TUNES stimulation will experience lower pain levels and improved early recovery compared to those receiving sham stimulation or standard care.

Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination

This study evaluates the feasibility, safety, and efficiency of transvaginal in-bag electromechanical morcellation for specimen extraction in patients undergoing total laparoscopic hysterectomy for large uteri.

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa). The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the fibroid procedure will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes. UC San Francisco will have oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center.

Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.

Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. The main question\[s\] it aims to answer are: * the benefit of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids * the safety of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids

to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia

The goal of this clinical trial was to determine whether the investigational drug KLH-2109 is effective for treating excessive menstrual bleeding in patients with uterine fibroids. Uterine fibroids are benign tumors that grown in the uterus. The primary objectives of this trial were to answer the following questions: * Does KLH-2109 lower the amount of menstrual bleeding? * Does KLH-2109 reduce menstrual bleeding? * Is KLH-2109 safe for participants to use? Investigators will compare KLH-2109 with a standard of care treatment (control) to determine which treatment is more effective. Participants will be required to follow: * Take either KLH-2109 or the common treatment as a pill * Visit the clinic regularly for health checkups and safety tests * Keep track of their bleeding and any health changes during the study

Effect of Addition of Steroids on Duration of Analgesia

The purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a Superior Hypogastric Nerve Block (SHNB) with and without corticosteroid performed as part of the Uterine Artery Embolization (UAE) procedure.

Prospective Validation Study of a Uterine Fibroid-Related Infertility Prediction Model

Female fertility may be affected by uterine fibroids, although this association has not been elucidated. Our retrospective study has already constructed a predictive model for infertility risk in patients with uterine fibroids using machine learning. We will now validate and optimize this model through a prospective study

An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms

This is a 24-week, single-arm, open-label, virtual study evaluating the effects of Elix Cycle Balance and Elix Daily Harmony on uterine fibroid-related symptoms and quality of life in 42 participants. Participants will self-administer the investigational herbal supplements daily and complete validated questionnaires at scheduled timepoints to assess symptom severity and quality of life.

A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.

Use of Nitrous Oxide During Office Hysteroscopy

The goal of this clinical trial is to assess the use of inhaled nitrous oxide during office hysteroscopy. The main questions it aims to answer are: * Does it reduce pain during the procedure? * Does it increase the success rate? * Does it improve patient satisfaction? * Does it reduce anxiety? * Which populations benefit more (e.g., parity, menopausal status, number of previous surgeries, type and duration of procedure, and type of device)? Participants will be asked about their pain levels during the procedure, as well as their anxiety levels. All responses will be recorded. Written informed consent will be obtained prior to initiation.

A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery

In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.

Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy

The aim of the study is to answer the question, whether in patients with symptomatic and medically not sufficiently treatable uterine fibroids (population) the "Magnetic-Resonance-Guided Focused Ultrasound Surgery" short, MRgFUS-TUF (intervention) offers less burdensome therapy and patient-relevant advantages (symptom relief) compared to the operative myomectomy (comparison). The study will hence investigate the therapeutic benefit of this method.

Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age

The study participants are patients with uterine fibroids and healthy physical examination subjects from the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital). The main purpose of this study is to analyze the correlation between uterine fibroids and vaginal microecology and cervical local immune function in patients of childbearing age.