Last reviewed · How we verify

NCT06302361

Lymphovenous Anastomosis for Breast Cancer Lymphedema

Active, enrolled NA Last updated 14 March 2025
What this trial tests

NA trial testing Lymphovenous anastomosis (LVA) in Lymphedema in 47 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 March 2024
Primary endpoint
30 June 2026
30 June 2026

Quick facts

Lead sponsorOdense University Hospital
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment47
Start date1 March 2024
Primary completion30 June 2026
Estimated completion30 June 2026
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Odense University Hospital

Who can join

18 and older, female only, with Lymphedema or Lymphedema Arm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment. Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires. Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months. The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated. The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Lymphedema

Currently open trials in the same condition.

Other Odense University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06302361.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing