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The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Secondary endpoints: details revised at 6 of 6 entries
    • Primary endpoint revised
    • Site details revised at 3 of 3 sites
    v7
  2. Publications: details revised at 1 of 1 entryv6
  3. Re-verified, no change to tracked fieldsv5
  4. Site details revised at 1 of 3 sitesv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Oct 24, 2026 to Mar 1, 2029
    • Start date changed from estimate of Oct 24, 2023 to Dec 18, 2023
    • Site details revised at 3 of 3 sites
    v3
  6. Site contacts updated at 3 of 3 sitesv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score. A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.
Trial Details
NCT Number NCT06082349
Lead Sponsor Maastricht University Medical Center
Collaborators: Radboud University Medical Center, Erasmus Medical Center
Conditions
(from sponsor)		 Lymphedema, Secondary, Lymphedema of Upper Limb, Lymphedema, Lower Limb, Lymphedema Arm, Lymphedema of Leg
Related terms Lymphedema, Neoplasm Metastasis
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov