Intraoperative Ureter Injury Clinical Trial
Official title:
A Phase 2 Open-label Study to Evaluate the Use of Nerindocianine as a Surgical Aid in the Delineation of Abdominopelvic Ureter Anatomy Via Near-infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03106038 -
Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery
|
Phase 1/Phase 2 |