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

Intuitive Surgical

Status and phase: Completed; Phase 2

Conditions: Ureter Injury

Treatments: Drug: IS-001; Drug: No treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03937505

ISI-124804-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Female subject is between the ages of 18 and 75, inclusive
2. Subject is scheduled to undergo robotic gynecological surgery using a da Vinci® surgical system with Firefly® fluorescent imaging
3. Subject is willing and able to provide informed consent
4. Subject is considered capable of complying with study procedures

Exclusion criteria

1. Subject is pregnant or nursing

2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

3. Subject is already enrolled in another investigational study 5. 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Dose-escalation

Experimental group

Description:

Dose-cohort escalation of single intravenous injection of IS-001 starting with 20 mg (n=8), escalating in 20 mg increments until optimal dose is determined.

Treatment:

Drug: IS-001

Optimal dose-characterization

Experimental group

Description:

Single intravenous injection of IS-001 at the optimal dose will be administered to subjects assigned to the treatment group. Safety control subjects will not receive any study drug but will undergo robotic surgery and all associated safety assessment clinical trial procedures.

Treatment:

Drug: IS-001

Drug: No treatment