A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
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- STATUS
- Recruiting
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- days left to enroll
- 44
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- participants needed
- 102
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- sponsor
- Intuitive Surgical
Alwin Klaassen, PhD
Primary Contact
George Washington University Hospital (7.0 mi away) Contact
+2 other locationSummary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.
Description
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci Surgical System and Firefly imaging. Stage A will be a dose-escalation to determine the optimal dose for ureter visualization and Stage B will be an expanded safety and efficacy evaluation of the optimal dose. Stage B will include a no-drug safety control to evaluate the effects of surgery alone on the safety parameters of the study.
Details
| Treatment | No Treatment, IS-001 |
|---|---|
| Clinical Study Identifier | NCT03937505 |
| Sponsor | Intuitive Surgical |
| Last Modified on | 29 October 2020 |
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