Active — Not RecruitingNot Applicable

A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery

United States15 participantsStarted 2021-09-24

Plain-language summary

The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK. * Age ≥18 years. Exclusion Criteria: * Women with hepatic dysfunction as evidenced by elevated transaminases (two times the upper limit of normal). * Women with a history of cirrhosis or other chronic liver disease. * Women with a documented severe or life threatening allergy to iodine. * Women with an allergy to ICG or severe allergy to iodinated contrast. * Women undergoing any free flap (non-pedicled) reconstruction.

What they're measuring

Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans

Timeframe: Up to 24 months

Trial details

NCT IDNCT05071976

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-24

View on ClinicalTrials.gov More Gynecologic Surgery trials