Clinical trial NCT03937505: A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ureter Injury
Keywords: robotic-assisted surgery
minimally invasive surgery
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2019-05-03
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate fluorescent intensity of ureter by signal to background analysis
timeFrame: 10 minutes
measure: Evaluate fluorescent intensity of ureter by signal to background analysis
timeFrame: 30 minutes
measure: Evaluate fluorescent intensity of ureter by signal to background analysis
timeFrame: 60 minutes
Secondary outcomes:
measure: Safety 12-Lead EKG Change from Baseline
timeFrame: 6 hours
measure: Incidence of abnormal blood work in tests results
timeFrame: 24 hours
measure: Incidence of abnormal blood work in tests results
timeFrame: 14 days
measure: Incidence of abnormal blood work in tests results
timeFrame: 24 hours
measure: Incidence of abnormal blood work in tests results
timeFrame: 14 days
measure: Incidence of abnormal urinalysis results
timeFrame: 14 days
measure: Safety Adverse Events Monitoring
timeFrame: 14 days
measure: Pharmacokinetics Maximal Concentration (Cmax) of Drug Plasma Levels
timeFrame: 0, 1-2 hours and 2-3 hours
measure: Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero to Last Sampling (AUClast)
timeFrame: 0, 1-2 hours and 2-3 hours
measure: Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUCinf)
timeFrame: 0, 1-2 hours and 2-3 hours
measure: Pharmacokinetics Drug Plasma Clearance (CL)
timeFrame: 0, 1-2 hours and 2-3 hours
measure: Pharmacokinetics Terminal Elimination Half-life (t1/2)
timeFrame: 0, 1-2 hours and 2-3 hours
measure: Pharmacokinetics Apparent Volume of Distribution (Vz)
timeFrame: 0, 1-2 hours and 2-3 hours
measure: Ureter Identification Efficacy on a Nominal Scale
timeFrame: 10 minutes
measure: Ureter Identification Efficacy on a Nominal Scale
timeFrame: 30 minutes
measure: Ureter Identification Efficacy on a Nominal Scale
timeFrame: 60 minutes
measure: Ureter Delineation Efficacy as Length of Line Drawn in Millimeters
timeFrame: 10 minutes
measure: Ureter Delineation Efficacy as Length of Line Drawn
timeFrame: 30 minutes
measure: Ureter Delineation Efficacy as Length of Line Drawn
timeFrame: 60 minutes
measure: Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
timeFrame: 10 minutes post-dose
measure: Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
timeFrame: 30 minutes post-dose
measure: Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
timeFrame: 60 minutes post-dose
measure: Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
timeFrame: 10 minutes post-dose
measure: Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
timeFrame: 30 minutes post-dose
measure: Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
timeFrame: 60 minutes post-dose
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Austin
country: United States
facility: St.David's Medical Center
state: Texas
city: El Paso
country: United States
facility: Las Palmas Medical Center
state: Texas
Study officials:
affiliation: Las Palmas Medical Center
name: Richard Farnam, MD
role: PRINCIPAL_INVESTIGATOR
References: