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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

Must not have

Participants diagnosed and/or treated for BCRL

Participants with bilateral BC (ie. contralateral staging SLNB or ALND)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6, 9 and 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am a woman over 18 who had breast cancer surgery with lymph node removal.

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I am at high risk of lymphedema because I had lymph nodes removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed or treated for lymphedema after breast cancer.

Select...

I have breast cancer in both breasts.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 9 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arm Volume

Secondary study objectives

Adherence rate to compression

Questionnaire Completion

Sensor Accuracy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met