CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
Flexitouch head and neck lymphedema treatment system +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03332160
NCT03332160N/ACompleted

A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment

Tactile Medical·interventional·Posted Nov 6, 2017·Updated Aug 6, 2020

In Brief

A clinical study evaluating Flexitouch head and neck lymphedema treatment system and Standard home lymphedema care for Head and Neck Neoplasms and 2 related conditions. Completed, enrolled 49 participants across 2 sites.

Detailed Summary

The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 6, 2017
Enrollment StartJan 2, 2018
Primary CompletionJun 4, 2019
Study CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.7 years ago

Interventions

Flexitouch head and neck lymphedema treatment systemdevice

Pneumatic compression device cleared for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: lymphedema; primary lymphedema; post mastectomy edema; edema following trauma and sports injuries; post immobilization edema; venous insufficiency; reducing wound healing time; treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. The Flexitouch system and garments for head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

Standard home lymphedema careother

May include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate).