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Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema

NCT02734979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-10-27

Study results available
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Summary

To investigate whether 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 arm.

Conditions

Interventions

DEVICE

Biobridge and lymph node transfer

Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery

Sponsors & Collaborators

Principal Investigators

  • Stanley G Rockson, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-20
Primary Completion
2018-07-07
Completion
2020-10-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734979 on ClinicalTrials.gov