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Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

NCT06831149 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-01-09

No results posted yet for this study

Summary

Investigators performing this research want to look at the use of a special imaging process during a specific throat surgery. Using this imaging may help to lower a common complication that called a pharyngocutaneous fistula (PCF). A PCF is a leak in the tube in the throat that helps with breathing and digesting food.

The imaging is called the SPY Fluorescence System. This system can identify tissue that is not receiving enough blood. The SPY Fluorescence System uses a special dye, called Indocyanine green (ICG) to better see the tissues that are not receiving enough blood. When tissue does not receive enough blood, it can lead to infection. Infection of tissue in this area of the throat can lead to PCF. The imaging takes about 1 minute and is performed in the operating room during surgery.

For this study, the investigators (who are also surgeons) will decide to remove tissue that is identified by the SPY Fluorescence System to have decreased blood flow. They will then continue with the rest of the surgery as usual. The investigators will monitor participants as they recover from surgery to identify any complications that may occur. For this research they are interested in complications during the first month after surgery since this is when PCF usually happens.

Investigators will use information that has been documented in the medical records of participants as well as during in-person physical examinations during inpatient recovery and outpatient clinical visits.

Conditions

Interventions

DRUG

ICG (Indocyanine Green)

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

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)

Sponsors & Collaborators

  • Matthew Spector

    lead OTHER

Principal Investigators

  • Matthew E Spector, MD · University of Pittsburgh/UPMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2028-02-28
Completion
2030-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06831149 on ClinicalTrials.gov