The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Jul 30, 2024
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
The Robot-LVA Study is looking at a new way to treat lymphedema, which is a condition that can cause swelling in the arms, particularly after breast cancer treatment. This study focuses on a surgical technique called lymphaticovenous anastomosis (LVA), which helps to reduce swelling by connecting lymph vessels to veins. Researchers want to compare how well this procedure works when performed by an expert using traditional methods versus using a robot-assisted approach.
To participate in this trial, women aged 65 to 74 who have had early-stage breast cancer and are experiencing mild to moderate swelling in one arm may be eligible. Participants will undergo the LVA procedure and will be monitored to see how effective it is in reducing their lymphedema. It’s important to know that this study is specifically for women with certain conditions and excludes those with more severe lymphedema or ongoing cancer treatment. If you or someone you know fits this description, it could be a good opportunity to help advance treatment options for lymphedema.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female gender;
- • Treated for primary early stage breast cancer;
- • Early stage lymphedema of the arm (stage 1 or 2 on ISL classification);
- • ELV \> 10%;
- • Suffering from unilateral disease.
- Exclusion Criteria:
- • Male gender;
- • Stage 3 lymphedema of the arm;
- • Receiving current breast cancer treatment;
- • Distant breast cancer metastases;
- • Current substance abuse;
- • History of marcaine or indocyanine green allergy;
- • Non-viable lymphatic system as determined by near infrared imaging;
- • Previous LVA (\<10 years) in the arm with lymphedema.
About Maastricht University Medical Center
Maastricht University Medical Center (MUMC+) is a leading academic medical center in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, MUMC+ integrates cutting-edge scientific inquiry with clinical practice, focusing on a wide range of medical disciplines. The center emphasizes collaboration among multidisciplinary teams, fostering an environment that promotes excellence in patient care and the translation of research findings into clinical applications. MUMC+ is dedicated to improving health outcomes and enhancing quality of life through rigorous clinical investigations and the development of novel therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Maastricht, Limburg, Netherlands
Patients applied
Trial Officials
Shan Shan Qiu Shao, MSc, PhD
Principal Investigator
Maastricht University Medical Center
Tom van Mulken, MSc
Study Chair
Maastricht University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported