[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579965":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":59,"collaborators":21,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":21,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":21,"enrollmentInfo":72,"targetDuration":21,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":45,"whyStopped":21,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"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",[12,13,14],"Procedure: Removal of pharyngeal mucosa with decreased perfusion will be performed","Device: SPY-PHI","Drug: ICG (Indocyanine Green)",[16,22,27],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"PROCEDURE","Removal of pharyngeal mucosa with decreased perfusion will be performed","Surgical removal of underperfused tissue versus nonremoval of tissue",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DEVICE","SPY-PHI","SPY Portable Handheld Imaging (SPY-PHI)",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":21},"DRUG","ICG (Indocyanine Green)","ICG will be used in conjunction with the SPY-PHI system for tissue imaging.",[9],[33],{"name":34,"affiliation":35,"role":36},"Matthew E Spector, MD","University of Pittsburgh\u002FUPMC","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":21,"email":41},"CONTACT","412-647-2100","spectorme@upmc.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"UPMC","RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-79.99589,40.44062,{"lat":55,"lon":54},[58],{"name":34,"role":39,"phone":40,"phoneExt":21,"email":41},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Matthew Spector","Professor of Otolaryngology - Head and Neck Surgery and Chief of the Head and Neck Surgery and Oncology Division.","100579965","phase-2-use-of-spy-imaging-system-to-minimize-fistulas-after-hypopharyngeal-reconstruction-100579965",false,"NCT06831149","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","Inclusion Criteria:\n\n1. Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)\n2. Prior treatment with radiation +\u002F- chemotherapy\n3. Presence of local recurrence of disease, radiation necrosis or an incompetent larynx\n4. 18 years or older. 5. Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n1. Iodine and Shellfish allergy\n2. Contraindication to surgery under general anesthesia\n3. 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\n4. Pregnancy or lactation.\n5. Patients residing in prison.","ALL","18 Years",{"count":73,"type":74},225,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","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.\n\nThe 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.\n\nFor 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.\n\nInvestigators 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.",[80,81],"Squamous Cell Carcinoma","Pharyngocutaneous Fistula",[83,84,85],"squamous cell carcinoma hypopharynx","squamous cell carcinoma larynx","SPY Fluorescence Imaging System","2026-01-07",{"date":88,"type":89},"2026-01-09","ACTUAL",{"date":91,"type":89},"2025-02-28",{"date":93,"type":74},"2030-02-28",{"name":61,"class":6},1]