NCT02946021

Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema

Assessment of Lymphatic Structure and Function Pre- and Post- Treatment and During Recovery in Head and Neck Cancer Patients Using NIR Fluorescence Lymphatic Imaging

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Tactile Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assessment of lymphatic structure and function pre- and post- treatment and during recovery in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging: Response to ICD therapy in HNC Patients.

Detailed description

A non-randomized, non-blinded, single site pilot study designed to assess whether near-infrared fluorescence imaging can report on the efficacy of a pneumatic compression device to move lymph in head and neck cancer survivors with resulting head and neck lymphedema.

Conditions

• Head and Neck Neoplasms
• Head and Neck Lymphedema
• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	Head and neck garments for pneumatic compression device	Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds; and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
DRUG	NIRFLI with ICG	Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-10-26
• Last updated: 2019-04-09
• Results posted: 2019-03-20

Locations

1 site across 1 country: United States