Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction
Recruiting
Phase 2
Interventional Study
Squamous Cell Carcinoma
Pharyngocutaneous Fistula
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 225 (estimated)
- Sponsor
- Matthew Spector · Other
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About This Trial
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 tis…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)
2. Prior treatment with radiation +/- chemotherapy
3. Presence of local recurrence of disease, radiation necrosis or an incompetent larynx
4. 18 years or older. 5. Ability to u…
Contacts