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Search / Trial NCT06532955

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

Robot Assisted Microsurgery Microsurgery Robot Robotic Assisted Robot Assisted Lymphaticovenous Anastomosis Lymphatico Venular Anastomosis Lva

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.

Locations

Maastricht, Limburg, Netherlands

Patients applied

0 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