Clinical Research Directory

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)

AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results. The study will enroll up to 800 eligible female patients. In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes. The study aims to validate ATUSA's image quality, reproducibility, and correlation with histopathology and radiologist-assigned BI-RADS categories. Additionally, a subset of participants receiving neoadjuvant therapy will be followed longitudinally to evaluate ATUSA's potential for monitoring treatment response and volumetric changes in tumor burden. This study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging.

Comparison of the Postoperative Analgesic Efficacy of SAP and SPSIP Blocks in Patients Undergoing Mammoplasty

The aim is to compare the postoperative analgesic efficacy of serratus anterior plane block (SAPB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing mammoplasty surgery. To this end, a double-blind, randomized, controlled study has been designed. Female patients aged 18-65 years who will undergo mammoplasty surgery will be included in the study. Postoperative pain levels, opioid consumption, duration of analgesic requirement, and patient satisfaction will be evaluated in patients who receive fascial blocks for analgesic purposes.

Study on the Effects of Acupuncture in Patients with Cyclic Mastalgia

This study is designed to evaluate the effectiveness of acupuncture in treating cyclic mastalgia (breast pain that occurs in a cyclical pattern, often related to the menstrual cycle). The study will take place at the Pinggu District Traditional Chinese Medicine Hospital in Beijing and also included volunteers who are interested in participating. Sixty-six patients who meet the criteria for cyclic mastalgia will be chosen to take part in the study.The patients will be randomly divided into two groups: Observation Group (Acupuncture Group): 33 patients receive real acupuncture treatments. Control Group (Sham Acupuncture Group): 33 patients receive sham acupuncture treatments. This means that neither the participants nor the researchers know who is receiving the real or fake treatment, ensuring a fair comparison. The study will last for 16 weeks. The main thing researchers look at is the change in daily average overall breast pain. Researchers also observe changes in:Infrared temperature at specific acupoints (Danzhong CV17, Rugen ST18, and Tianzong SI11).Meridian energy values of the Liver, Spleen, and Stomach meridians, which are concepts in Traditional Chinese Medicine related to the flow of energy in the body. This study helps us understand whether acupuncture is an effective treatment for cyclic mastalgia. By comparing real acupuncture to sham acupuncture, researchers can determine if the improvements seen are due to the acupuncture treatment itself or other factors like the placebo effect. What does this mean for patients? If you suffer from cyclic mastalgia, this study provides valuable information about the potential benefits of acupuncture as a treatment option. It's important to discuss any treatment options with your health care provider to determine the best approach for your specific situation. What does this mean for health care providers? This study contributes to the evidence-base for treating cyclic mastalgia with acupuncture. Understanding the results of this study can help health care providers make informed decisions when discussing treatment options with their patients. Overall, this well-designed study offers insights into the use of acupuncture for cyclic mastalgia, which can be beneficial for both patients and health care providers in making informed decisions about treatment.