A Registry to Evaluate the Flexitouch System & Flexitouch Plus for

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Terminated	`NCT04335981` - Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression	N/A
Completed	`NCT02946021` - Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema	Phase 1/Phase 2
Completed	`NCT03332160` - A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment	N/A

NCT number	NCT03558672
Study type	Observational [Patient Registry]
Source	Tactile Medical
Contact
Status	Terminated
Phase
Start date	September 14, 2018
Completion date	May 1, 2020

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms