NCT03937505

A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy

A Phase 2 Multi-Center Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Ureter Injury

Interventions

Type	Name	Description
DRUG	IS-001	intravenous injection of IS-001 investigational drug
DRUG	No treatment	no drug injection

Timeline

• Start date: 2019-05-28
• Primary completion: 2021-07-08
• Completion: 2021-07-22
• First posted: 2019-05-03
• Last updated: 2021-08-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study