NCT06831149View on ClinicalTrials.gov

Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

PHASE2RecruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

February 28, 2028

Study Completion Date

February 28, 2030

Conditions
Squamous Cell CarcinomaPharyngocutaneous Fistula
Interventions
PROCEDURE

Removal of pharyngeal mucosa with decreased perfusion will be performed

Surgical removal of underperfused tissue versus nonremoval of tissue

DEVICE

SPY-PHI

SPY Portable Handheld Imaging (SPY-PHI)

DRUG

ICG (Indocyanine Green)

ICG will be used in conjunction with the SPY-PHI system for tissue imaging.

Trial Locations (1)

15213

RECRUITING

UPMC, Pittsburgh

All Listed Sponsors
lead

Matthew Spector

OTHER