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

Status: Terminated
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• A diagnosis of head and/or neck lymphedema

• Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation

• Head and chest measurements within the following:

• Crown of head circumference: ≤ 72 cm

• Chest circumference: ≤ 158 cm

• Prescribed the Flexitouch system or Flexitouch Plus

Locations
United States
Iowa
Iowa ENT Center
West Des Moines
North Carolina
Charles George VA Medical Center
Asheville
Ohio
The Ohio State University
Columbus
Pennsylvania
Allegheny General Hospital
Pittsburgh
Time Frame
Start Date: 2018-09-14
Completion Date: 2020-05-01
Participants
Target number of participants: 18
Related Therapeutic Areas
Sponsors
Leads: Tactile Medical

This content was sourced from clinicaltrials.gov