Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
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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