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

Ureter Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937505
• Other study ID #: ISI-124804-2
• Status: Completed
• Phase: Phase 2
• Start date: May 28, 2019
• Est. completion date: July 22, 2021

Study information

• Verified date: August 2021
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 22, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ureter Injury

Intervention

Drug:
• IS-001
intravenous injection of IS-001 investigational drug
• No treatment
no drug injection

Locations

Country	Name	City	State
United States	St.David's Medical Center	Austin	Texas
United States	Las Palmas Medical Center	El Paso	Texas
United States	George Washington University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate fluorescent intensity of ureter by signal to background analysis	Fluorescent intensity of ureter evaluated as signal to background	10 minutes
Primary	Evaluate fluorescent intensity of ureter by signal to background analysis	Fluorescent intensity of ureter evaluated as signal to background	30 minutes
Primary	Evaluate fluorescent intensity of ureter by signal to background analysis	Fluorescent intensity of ureter evaluated as signal to background	60 minutes
Secondary	Safety 12-Lead EKG Change from Baseline	12-Lead EKG change from baseline in QTc	6 hours
Secondary	Incidence of abnormal blood work in tests results	Safety hematology complete blood count laboratory assessments Change from Baseline	24 hours
Secondary	Incidence of abnormal blood work in tests results	Safety hematology complete blood count laboratory assessments Change from Baseline	14 days
Secondary	Incidence of abnormal blood work in tests results	Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline	24 hours
Secondary	Incidence of abnormal blood work in tests results	Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline	14 days
Secondary	Incidence of abnormal urinalysis results	Routine urinalysis laboratory assessment change from baseline	14 days
Secondary	Safety Adverse Events Monitoring	Drug related adverse events monitoring through 14-days	14 days
Secondary	Pharmacokinetics Maximal Concentration (Cmax) of Drug Plasma Levels	Maximal concentration of investigational drug-plasma levels (Cmax)	0, 1-2 hours and 2-3 hours
Secondary	Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero to Last Sampling (AUClast)	Area under the plasma curve from t(0) to last plasma sample	0, 1-2 hours and 2-3 hours
Secondary	Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUCinf)	Area under the plasma curve from t(0) extrapolated to infinity	0, 1-2 hours and 2-3 hours
Secondary	Pharmacokinetics Drug Plasma Clearance (CL)	Clearance of the investigational drug from plasma	0, 1-2 hours and 2-3 hours
Secondary	Pharmacokinetics Terminal Elimination Half-life (t1/2)	Half-life of the investigational drug in plasma	0, 1-2 hours and 2-3 hours
Secondary	Pharmacokinetics Apparent Volume of Distribution (Vz)	The apparent volume of distribution of the investigational drug	0, 1-2 hours and 2-3 hours
Secondary	Ureter Identification Efficacy on a Nominal Scale	Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes	10 minutes
Secondary	Ureter Identification Efficacy on a Nominal Scale	Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes	30 minutes
Secondary	Ureter Identification Efficacy on a Nominal Scale	Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes.	60 minutes
Secondary	Ureter Delineation Efficacy as Length of Line Drawn in Millimeters	Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.	10 minutes
Secondary	Ureter Delineation Efficacy as Length of Line Drawn	Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.	30 minutes
Secondary	Ureter Delineation Efficacy as Length of Line Drawn	Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.	60 minutes
Secondary	Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale	Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.	10 minutes post-dose
Secondary	Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale	Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.	30 minutes post-dose
Secondary	Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale	Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.	60 minutes post-dose
Secondary	Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale	Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points.	10 minutes post-dose
Secondary	Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale	Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points	30 minutes post-dose
Secondary	Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale	Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points.	60 minutes post-dose