Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

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 n

Trial Details

NCT ID
NCT06831149
Phase
PHASE2
Sponsor
Matthew Spector
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Removal of pharyngeal mucosa with decreased perfusion will be performed
  • SPY-PHI
  • ICG (Indocyanine Green)
Locations (sample)
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility Criteria

  • Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)
  • Prior treatment with radiation +/- chemotherapy
  • Presence of local recurrence of disease, radiation necrosis or an incompetent larynx
  • 18 years or older. 5. Ability to understand and sign informed consent

For full eligibility, visit ClinicalTrials.gov.

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