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NCT05825157 · ClinicalTrials.gov registry record · NA
Evaluation of Combination Therapy for Upper Extremity Lymphedema
A NA study of Lymphedema Arm, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05825157: Recruiting NA study of Lymphedema Arm, sponsored by Stanford University.
NCT05825157 is a NA study of Lymphedema Arm that is actively recruiting participants, run by Stanford University. The registered enrollment target is 60 participants, below the 125-participant average among 4 other Lymphedema Arm trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05825157, a NA study of Lymphedema Arm, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Investigate whether the addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. Will Biobridge improve upon the low success rate of the currently practiced surgery by facilitating the lymphatic connections to the transplanted node that are crucial to its viability and function.
Primary Outcome
To measure the post-surgical percent change in excess limb volume measured at 12 months following surgery using BioBridge scaffold as an adjunct to vascularized lymph node transfer for treatment of upper extremity lymphedema
Conditions Studied
Interventions
- DEVICE BioBridge
Study Locations (1)
California
- Stanford Hospital and Clinics - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-11-17 |
| Est. Completion | 2029-01-01 |
| Phase | NA |
What NCT05825157 shows while recruiting
NCT05825157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 125-participant average among 4 other Lymphedema Arm trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Lymphedema Arm appearing as the primary indexed condition, and to 1 intervention - of which BioBridge is the first listed.
NCT05825157 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05825157 about?
NCT05825157 is a clinical study titled "Evaluation of Combination Therapy for Upper Extremity Lymphedema". Investigate whether the addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. Will Biobridge improve upon the low success rate of the currently practiced surgery by facilita...
What is the current status of trial NCT05825157?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2023-11-17. Estimated completion is 2029-01-01.
What conditions does trial NCT05825157 study?
This clinical trial studies the following conditions: Lymphedema Arm.
What interventions are being tested in trial NCT05825157?
The interventions under investigation include: BioBridge (DEVICE).
Who is sponsoring clinical trial NCT05825157?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05825157 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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