NCT06831149RecruitingPhase 2
Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction
A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 225 (estimated)
- First submitted
- 13 Feb 2025
- Start date
- 28 Feb 2025
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- Matthew Spector
- Diseases
- Head and neck cancer
- NCT number
- NCT06831149
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 225
- From 28 Feb 2025 to the primary completion date, 28 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to surgery under general anesthesia
- Anticipated extended laryngectomy (laryngopharyngectomy or laryngopharyngoesophagectomy) with the need for free tissue transfer to reconstruct the pharyngeal mucosa. This may only be determined at the time of surgery
Other illness
- Iodine and Shellfish allergy
Other
- Pregnancy or lactation.
- Patients residing in prison.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.