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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2021-07-22

Brief Summary

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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.

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Detailed Description

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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

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Ureter Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Stage A is a dose-cohort escalation to determine optimal efficacious dose, Stage B is an expanded safety and efficacy evaluation of the optimal dose with a no-drug safety control group

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dose-escalation

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.

Group Type EXPERIMENTAL

IS-001

Intervention Type DRUG

intravenous injection of IS-001 investigational drug

Optimal dose-characterization

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.

Group Type EXPERIMENTAL

IS-001

Intervention Type DRUG

intravenous injection of IS-001 investigational drug

No treatment

Intervention Type DRUG

no drug injection

Interventions

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IS-001

intravenous injection of IS-001 investigational drug

Intervention Type DRUG

No treatment

no drug injection

Intervention Type DRUG

Eligibility Criteria

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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

4\. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes