Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery (e.g. gynecological, lower gastrointestinal, or other lower abdominal surgery).
The primary objective of this study is to assess the acceptance of near-infrared (NIR) fluorescence imaging (650 to 900 nm) compared to white light (WL) using 3 3-point Likert scales.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Procedure: routine minimally invasive abdominopelvic surgery.
Cleveland Clinic Florida
Weston, Florida, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Evaluation of ureter delineation using a Likert scale to measure ureter visualization
Evaluation of the pelvic ureter under WL and NIR illumination
Time frame: Surgical procedure duration, estimated up to 5 hours
Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events
Time frame: 30 +/- 5 days
Hourly time point scores concurrence with video review
Three 3-pt Likert scale scores at hourly time points during the procedure.
Time frame: Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours)
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