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NCT06831149 · ClinicalTrials.gov registry record · Phase 2
Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction
A Phase 2 study of Squamous Cell Carcinoma and Pharyngocutaneous Fistula, sponsored by Matthew Spector.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 225
- Enrollment target
- 1
- Study location
NCT06831149: Recruiting Phase 2 study of Squamous Cell Carcinoma and Pharyngocutaneous Fistula, sponsored by Matthew Spector.
NCT06831149 is a Phase 2 study of Squamous Cell Carcinoma and Pharyngocutaneous Fistula that is actively recruiting participants, run by Matthew Spector. The registered enrollment target is 225 participants, above the 99-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (127% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06831149, a Phase 2 study of Squamous Cell Carcinoma and Pharyngocutaneous Fistula, is actively recruiting participants, sponsored by Matthew Spector.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 225 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Incidence of PCF, in participants identified as "high risk", utilizing the SPY Fluorescence Imaging System during total laryngectomy (TL) surgical procedure, within one month post TL. Incidence of PCF will be monitored during post operative, inpatient hospitalization as well as clinical outpatient follow up.
Conditions Studied
Interventions
- DEVICE SPY-PHI
- PROCEDURE Removal of pharyngeal mucosa with decreased perfusion will be performed
- DRUG ICG (Indocyanine Green)
Study Locations (1)
Pennsylvania
- UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2025-02-28 |
| Est. Completion | 2030-02-28 |
| Phase | Phase 2 |
What NCT06831149 shows while recruiting
NCT06831149 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 99-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (127% higher).
The record links to 2 conditions, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which SPY-PHI is the first listed.
NCT06831149 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06831149 about?
NCT06831149 is a clinical study titled "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 ...
What is the current status of trial NCT06831149?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2025-02-28. Estimated completion is 2030-02-28.
What conditions does trial NCT06831149 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma, Pharyngocutaneous Fistula.
What interventions are being tested in trial NCT06831149?
The interventions under investigation include: SPY-PHI (DEVICE), Removal of pharyngeal mucosa with decreased perfusion will be performed (PROCEDURE), ICG (Indocyanine Green) (DRUG).
Who is sponsoring clinical trial NCT06831149?
This trial is sponsored by Matthew Spector, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06831149 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06831149's enrollment target sits among peer trials
225 5th of 47 higher than 43 of 47 other Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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