A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery

A Phase 2 Multi-Center Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation

Study Overview

• Status: Completed
• Conditions: Ureter Injury
• Intervention / Treatment: Drug: IS-001

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 feasibility of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78758
      • St. David's North Austin Medical Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Tacoma General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female subjects between the ages of 18 and 75, inclusive
2. Subject is scheduled to undergo robotic-assisted rectal, sigmoid, or left colon resection surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging

Exclusion Criteria:

1. Subject is pregnant or nursing
2. Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

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

   1. eGFR < 60 mL/min/1.73 m^2
   2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
   3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
4. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
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
6. Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Single Arm Safety and Feasibility Study of IS-001 with 20 mg in Multiple Injections	Drug: IS-001; Intravenous injection of IS-001 investigational drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate ureter visualization by Independent Reader	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 Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	10 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader	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 Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	30 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader	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 Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	45 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader	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 Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	10 minutes after second IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader	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 Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	30 minutes after second IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader	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 Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	45 minutes after second IS-001 injection during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate ureter visualization by Intra-operative surgeon	Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	10 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon	Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	30 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon	Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	45 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon	Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	10 minutes after second IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon	Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	30 minutes after second IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon	Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible	45 minutes after second IS-001 injection during surgery
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.	10 minutes after first IS-001 injection during surgery
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 after first IS-001 injection during surgery
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.	45 minutes after first IS-001 injection during surgery
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.	10 minutes after second IS-001 injection during surgery
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 after second IS-001 injection during surgery
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.	45 minutes after second IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis	Fluorescent intensity of ureter evaluated as signal to background	10 minutes after first IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis	Fluorescent intensity of ureter evaluated as signal to background	30 minutes after first IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis	Fluorescent intensity of ureter evaluated as signal to background	45 minutes after first IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis	Fluorescent intensity of ureter evaluated as signal to background	10 minutes after second IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis	Fluorescent intensity of ureter evaluated as signal to background	30 minutes after second IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis	Fluorescent intensity of ureter evaluated as signal to background	45 minutes after second IS-001 injection during surgery
Safety 12-Lead EKG Change from Baseline	12-Lead EKG change from baseline in QTc	6 hours after first IS-001 injection post surgery
Incidence of abnormal blood work in tests results	Safety hematology complete blood count laboratory assessments Change from Baseline	14 days post surgery
Incidence of abnormal blood work in tests results	Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline	14 days post surgery
Incidence of abnormal urinalysis results	Routine urinalysis laboratory assessment change from baseline	14 days post surgery
Safety Adverse Events Monitoring	Drug related adverse events monitoring through 14-days	14 days post surgery
Incidence of abnormal blood work in tests results	Safety hematology complete blood count laboratory assessments Change from Baseline	Before same-day discharge or 24 hours after first IS-001 injection post surgery
Incidence of abnormal blood work in tests results	Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline	Before same-day discharge or 24 hours after first IS-001 injection post surgery

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Thiru Lakshman, MD, St. David's North Austin Medical Center; Principal Investigator: Laila Rashidi, MD, MultiCare Tacoma General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Actual): March 18, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ISI-124804-CR-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No