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

Phase 2

Completed

• Conditions: Ureter Injury
• Interventions: Drug: IS-001

• Registration Number: NCT05769257
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-15
• Study Start: 2023-06-14
• Primary Completion: 2024-03-18
• Study Completion: 2024-04-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	IS-001	Single Arm Safety and Feasibility Study of IS-001 with 20 mg in Multiple Injections

Primary Outcome Measures

Name	Time	Method
Evaluate ureter visualization by Independent Reader	45 minutes after second IS-001 injection during surgery	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

Secondary Outcome Measures

Name	Time	Method
Evaluate fluorescent intensity of ureter by signal to background analysis	45 minutes after second IS-001 injection during surgery	Fluorescent intensity of ureter evaluated as signal to background
Incidence of abnormal blood work in tests results	14 days post surgery	Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
Evaluate ureter visualization by Intra-operative surgeon	45 minutes after second IS-001 injection during surgery	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
Safety 12-Lead EKG Change from Baseline	6 hours after first IS-001 injection post surgery	12-Lead EKG change from baseline in QTc
Incidence of abnormal urinalysis results	14 days post surgery	Routine urinalysis laboratory assessment change from baseline
Safety Adverse Events Monitoring	14 days post surgery	Drug related adverse events monitoring through 14-days
Ureter Delineation Efficacy as Length of Line Drawn	45 minutes after second IS-001 injection during surgery	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.

Trial Locations

Locations (2)

MultiCare Tacoma General Hospital; 🇺🇸 Tacoma, Washington, United States

St. David's North Austin Medical Center; 🇺🇸 Austin, Texas, United States