Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Matthew Spector
Study ID
NCT06831149
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Removal of pharyngeal mucosa with decreased perfusion will be performed — PROCEDURE
    Surgical removal of underperfused tissue versus nonremoval of tissue
  • SPY-PHI — DEVICE
    SPY Portable Handheld Imaging (SPY-PHI)
  • ICG (Indocyanine Green) — DRUG
    ICG will be used in conjunction with the SPY-PHI system for tissue imaging.

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Jan 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2030

Study Design

Enrollment
225 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Patients having salvage TL after failure with radiation or chemoradiation
    SPY intraoperative fluorescent angiography system to risk stratify patients intraoperatively into low and high risk groups for developing pharyngocutaneous fistula (PCF) postoperatively

Primary Outcome Measure

Incidence of PCF, within one month post total laryngectomy (TL) [ Time Frame: From enrollment through 1 month post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMCPittsburghPennsylvania15213
Matthew E Spector, MD
[email protected]
412-647-2100

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