Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06831149

Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

Led by Matthew Spector · Updated on 2026-01-09

225

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)
  • Prior treatment with radiation with or without chemotherapy
  • Presence of local recurrence of disease, radiation necrosis, or an incompetent larynx
  • 18 years or older
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Allergy to iodine or shellfish
  • Contraindication to surgery under general anesthesia
  • Anticipated extended laryngectomy requiring free tissue transfer for pharyngeal reconstruction
  • Pregnancy or lactation
  • Patients residing in prison

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UPMC

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

M

Matthew E Spector, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction | DecenTrialz