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

  • STATUS
    Recruiting
  • days left to enroll
    40
  • participants needed
    102
  • sponsor
    Intuitive Surgical
Updated on 29 October 2020
Investigator
Alwin Klaassen, PhD
Primary Contact
George Washington University Hospital (7.0 mi away) Contact
+2 other location

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.

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 IdentifierNCT03937505
SponsorIntuitive Surgical
Last Modified on29 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Are you female?
Do you have Ureter Injury?
Female subject is between the ages of 18 and 75, inclusive
Subject is scheduled to undergo robotic hysterectomy using a da Vinci surgical system with Firefly fluorescent imaging
Subject is willing and able to provide informed consent
Subject is considered capable of complying with study procedures

Exclusion Criteria

Subject is pregnant or nursing
Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Subject has been diagnosed with or treated for cancer in the last 12 months
Subject is already enrolled in another investigational study
Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
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