IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery

Ureter Injury Clinical Trial

Official title:

A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954767
• Other study ID #: ISI-124804-3
• Status: Recruiting
• Phase: Phase 3
• Start date: January 17, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Intuitive Surgical
• Contact: Karen Hwang
• Phone: 1-800-876-1310
• Email: karen.hwang[@]intusurg.com
• 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 237
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Inclusion Criteria

1. Female subject is between the ages of 18 and 75, inclusive.

2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® surgical system with Firefly® fluorescent imaging.

3. Subject is willing and able to provide informed consent.

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 drug or device study receiving therapeutic agents within the past 6 months

4. 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.

5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG)

6. Subject has any of the following screening laboratory values:

1. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2

2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) = 2.5 × upper limit normal (ULN)

3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) = 2.5 × upper limit normal (ULN).

Related Conditions & MeSH terms

• Ureter Injury

Intervention

Drug:
• IS-001
IV injection of IS-001 drug substance with near infrared (NIR) imaging

Locations

Country	Name	City	State
United States	St. David's Surgical Hospital	Austin	Texas
United States	OhioHealth	Columbus	Ohio
United States	The Ohio State Unversity	Columbus	Ohio
United States	The Hospital of Providence Transmountain Campus	El Paso	Texas
United States	E.W. Sparrow Hospital	Lansing	Michigan
United States	MountainView Hospital	Las Vegas	Nevada
United States	HCA Mercy Hospital	Miami	Florida
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible after second injection	Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes	10 minutes
Other	Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible after second injection	Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes	30 minutes
Other	Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible after second injection	Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes	45 minutes
Other	Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection	Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode after second injection for procedures lasting longer than 60 minutes	10 minutes
Other	Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection	Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode after second injection for procedures lasting longer than 60 minutes.	30 minutes
Other	Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection	Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode after second injection for procedures lasting longer than 60 minutes.	45 minutes
Other	Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible - 2nd injection	Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes	10 minutes
Other	Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible - 2nd injection	Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes	30 minutes
Other	Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible - 2nd injection	Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes	45 minutes
Primary	Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.	Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection	10 minutes
Primary	Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible	Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection	30 minutes
Secondary	Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length	Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after injection	10
Secondary	Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length	Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after injection	30
Secondary	Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible	Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection	10 minutes
Secondary	Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible	Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection	30 minutes
Secondary	Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible	Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection	45 minutes
Secondary	Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length	Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection	45 minutes
Secondary	Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible	Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection	45 minutes
Secondary	Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode	Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.	10 minutes
Secondary	Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode	Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.	30 minutes
Secondary	Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode	Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.	45 minutes
Secondary	concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment	Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location	10 minutes
Secondary	concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment	Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location	30 minutes
Secondary	concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment	Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location	45 minutes
Secondary	Determine degree of concordance of ureter visualization between independent readers	Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location	10 minutes
Secondary	Determine degree of concordance of ureter visualization between independent readers	Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location	30 minutes
Secondary	Determine degree of concordance of ureter visualization between independent readers	Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location	45 minutes
Secondary	degree of concordance of ureter visualization within independent readers	Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location	10 minutes
Secondary	degree of concordance of ureter visualization within independent readers	Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location	30 minutes
Secondary	degree of concordance of ureter visualization within independent readers	Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location	45 minutes