Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months after treatment
Awards & highlights
Study Summary
This trial looks into how adding a device to standard surgery for upper arm lymphedema may improve outcomes.
Who is the study for?
This trial is for breast cancer survivors aged 18-75 with Stage I-II upper limb lymphedema after treatment, who've completed a full course of decongestive therapy. Participants must be free of cancer for 3 years, have no severe organ dysfunction or clotting disorders, not be pregnant or nursing, and able to undergo surgery.Check my eligibility
What is being tested?
The study tests if adding BioBridge® Collagen Matrix to standard vascularized lymph node transfer surgery improves outcomes in treating arm swelling due to lymphedema in breast cancer survivors.See study design
What are the potential side effects?
Potential side effects may include reactions related to the surgical procedure such as infection, pain at the site of surgery, swelling beyond the preoperative condition, and possible allergic reactions to materials used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 months after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Excess limb volume change
Secondary outcome measures
Histology
ICG fluorescence imaging
L-Dex bioimpedance spectroscopy.
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BioBridge treatment groupExperimental Treatment2 Interventions
Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation
Group II: Control groupActive Control1 Intervention
Vascularized Lymph Node Transplant surgery (VLNT) only
Find a Location
Who is running the clinical trial?
Fibralign CorporationLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Lymphedema
60 Patients Enrolled for Lymphedema
Stanford UniversityOTHER
2,397 Previous Clinical Trials
17,342,295 Total Patients Enrolled
13 Trials studying Lymphedema
6,512 Patients Enrolled for Lymphedema
Dung H Nguyen, MD, PharmDStudy DirectorStanford University
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Lymphedema
60 Patients Enrolled for Lymphedema
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swelling due to fluid leakage from blood vessels.I finished my breast cancer treatment 3 years ago and currently have no signs of the disease.I have not had an infection in my swollen limb in the last month.I have a long-lasting infection in my limb.I have had cancer or signs of it in the last 3 years.I have long-term kidney problems.I am a candidate for surgery.I have swelling in one limb that doesn't go away with rest or compression.I will wear compression garments for the whole study.I have a history of blood clots.I am between 18 and 75 years old.I have a condition causing sudden swelling in my limbs.My lymphedema is in the early to mid-stage.I am willing and able to follow all study requirements.The size of your affected limb cannot be significantly different (more than 10%) from the size of your unaffected limb.I cannot safely have surgery under general anesthesia for lymph node transfer.I am a breast cancer survivor, 3 years post-treatment, disease-free, and can undergo surgery.I can care for myself and am up and about more than 50% of my waking hours.I am currently undergoing chemotherapy or radiation therapy.I have liver problems.I completed lymphedema therapy over 12 weeks ago.I have swelling in my arm due to breast cancer treatment.I have swelling in one limb that doesn't go away with rest or compression.I started treatment for lymphedema less than 12 weeks ago.I completed a full lymphedema treatment program 12 weeks ago, including wearing compression garments.
Research Study Groups:
This trial has the following groups:- Group 1: BioBridge treatment group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I partake in this medical study?
"This study is seeking out people aged 18 to 75 who are suffering from lymphedema; enrolment for the trial will be capped at 60 participants."
Answered by AI
Does this study encompass those aged thirty and above?
"This trial is open to all individuals aged between 18 and 75. Specialized studies are available for those younger than 18, as well as over 65s who can choose from 155 different options."
Answered by AI
What is the upper limit of participants enrolled in this medical trial?
"Affirmative. The information provided on clinicaltrials.gov suggests that this trial is still open to participants, and it was initially posted on March 1st 2023 with the last edit transpiring on January 13th 2023. This medical study requires 60 people from a single research site."
Answered by AI
Are individuals currently being accepted into this experiment?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial is actively seeking recruits, which began being posted on March 1st 2023 and was most recently updated January 13th of the same year. 60 patients must be enrolled from a single medical center for the study to move forward."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger