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CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema

NCT04116099 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2022-03-31

No results posted yet for this study

Summary

Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.

Conditions

  • Lymphedema

Interventions

OTHER

Conservative care

May include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.

DEVICE

Flexitouch Plus

Flexitouch Plus treatment.

Sponsors & Collaborators

  • Tactile Medical

    lead INDUSTRY

Principal Investigators

  • Peter Pappas · Center for Vein Restoration

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2021-11-24
Completion
2021-11-24
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04116099 on ClinicalTrials.gov