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A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema

NCT03558672 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2020-09-02

Study results available
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Summary

The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events.

Conditions

  • Head and Neck Lymphedema

Interventions

DEVICE

Flexitouch system with Head and Neck Garments

Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed

Sponsors & Collaborators

  • Tactile Medical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2020-05-01
Completion
2020-05-01
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 NCT03558672 on ClinicalTrials.gov