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

NCT05769257 | Completed Phase 2 FDA Drug

• 1 other identifier: ISI-124804-CR-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Ureter Injury

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (25)

• Evaluate ureter visualization by Intra-operative surgeon

  10 minutes after first IS-001 injection during surgery

• Evaluate ureter visualization by Intra-operative surgeon

  30 minutes after first IS-001 injection during surgery

• Evaluate ureter visualization by Intra-operative surgeon

  45 minutes after first IS-001 injection during surgery

• Evaluate ureter visualization by Intra-operative surgeon

  10 minutes after second IS-001 injection during surgery

• Evaluate ureter visualization by Intra-operative surgeon

  30 minutes after second IS-001 injection during surgery

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: IS-001

Interventions

IS-001 DRUG

Intravenous injection of IS-001 investigational drug

Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between the ages of 18 and 75, inclusive
• 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

You may not qualify if:

• Subject is pregnant or nursing
• Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Subject has any of the following screening laboratory values:
• eGFR \< 60 mL/min/1.73 m\^2
• Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
• Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
• Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
• 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
• Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (2)

St. David's North Austin Medical Center

Austin, Texas, 78758, United States

Location

MultiCare Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Interventions

IS 001

Study Officials

• Thiru Lakshman, MD

  St. David's North Austin Medical Center

  PRINCIPAL INVESTIGATOR

• Laila Rashidi, MD

  MultiCare Tacoma General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: March 15, 2023
• Study Start: June 14, 2023
• Primary Completion: March 18, 2024
• Study Completion: April 4, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)