CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
NIRFLI with ICG +1 moredrug
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/NCT02946021
NCT02946021Phase 2Completed

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

Tactile Medical·interventional·Posted Oct 26, 2016·Updated Apr 9, 2019

In Brief

A Phase 2 clinical trial evaluating Head and neck garments for pneumatic compression device and NIRFLI with ICG for Head and Neck Neoplasms and 2 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 26, 2016
Enrollment StartOct 1, 2016
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.7 years ago

Interventions

Head and neck garments for pneumatic compression devicedevice

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

NIRFLI with ICGdrug

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.