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

NACompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

January 2, 2018

Primary Completion Date

June 4, 2019

Study Completion Date

July 31, 2019

Conditions
Head and Neck NeoplasmsHead and Neck CancerHead and Neck Lymphedema
Interventions
DEVICE

Flexitouch head and neck lymphedema treatment system

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.

OTHER

Standard home lymphedema care

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

Trial Locations (2)

37240

Vanderbilt University, Nashville

62702

SIU School of Medicine, Springfield

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Vanderbilt University

OTHER

lead

Tactile Medical

INDUSTRY

NCT03332160 - A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment | Biotech Hunter | Biotech Hunter