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Compression Sleeve
Sensor-Embedded Compression Sleeve for Lymphedema
N/A
Waitlist Available
Led By Alphonse G Taghian, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participants >/= 18 years who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (ALND) (with or without contralateral prophylactic SLNB)
Patients at high risk of BCRL, i.e., those who have undergone ALND
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 9 and 12 months
Awards & highlights
Study Summary
This trial is testing whether a compression sleeve with an embedded sensor can help prevent lymphedema.
Who is the study for?
This trial is for women over 18 who've had breast cancer surgery with lymph node removal and are at high risk of developing arm swelling (lymphedema). They must understand English, be able to consent, and have slight swelling post-surgery. It's not for those with bilateral breast cancer, existing lymphedema treatment, metastases causing lymphedema, or pregnant women.Check my eligibility
What is being tested?
The study tests a Juzo Compression Sleeve and Glove equipped with a sensor designed to prevent lymphedema in patients after breast cancer surgery. This pilot study aims to see if the smart sleeve can detect changes that might indicate early stages of swelling.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the compression sleeve and glove. Since it's non-invasive monitoring equipment, significant side effects are unlikely compared to drug interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 18 who had breast cancer surgery with lymph node removal.
Select...
I am at high risk of lymphedema because I had lymph nodes removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, 6, 9 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 9 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Arm Volume
Secondary outcome measures
Adherence rate to compression
Questionnaire Completion
Sensor Accuracy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Compression therapyExperimental Treatment2 Interventions
Participants will receive a ready to wear compression sleeve and glove with embedded sensor.
Compression sleeve will be set to 20-30mm Hg pressure with instructions to wear for 12 hours a day for four consecutive weeks.
Participants will also receive a journal to record usage and standard of care post-operative lymphedema monitoring and education and asked to fill out questionnaires.
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Who is running the clinical trial?
Olayan-Xefos Family Fund for Breast Cancer ResearchUNKNOWN
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,315 Total Patients Enrolled
80 Trials studying Breast Cancer
132,872 Patients Enrolled for Breast Cancer
Adele McKinnon Research Fund for Breast Cancer-Related LymphedemaUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed or treated for lymphedema after breast cancer.I have breast cancer in both breasts.I am a woman over 18 who had breast cancer surgery with lymph node removal.I have cancer spread that could lead to lymphedema in my arm.I have had swelling of 5-10% for more than 12 weeks after surgery.I am at high risk of lymphedema because I had lymph nodes removed.You have a heart device implanted in your body, or you are pregnant, for the Sozo measurement part of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Compression therapy
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.
Are there any available positions in this medical trial for new participants?
"This specific investigation is no longer recruiting, as per the information accessible on clinicaltrials.gov. The trial was initially published on October 1st 2022 and last amended thirteen days ago in April 2022. However, there are currently 2,641 other trials that require participants to join their study programs."
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