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

A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ureter Injury
• Intervention / Treatment: Drug: filricianine

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

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Project Manager; Phone Number: 4085232100; Email: info.is-001@intusurg.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female participants between the ages of 16 and 75, inclusive
2. Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging Exclusion Criteria

1. Participant is pregnant or nursing 2. Participant has known current acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Participant has any of the following screening laboratory values: eGFR < 30 mL/min/1.73 m2

1. Aspartate aminotransferase (AST) ≥ 2.5 × ULN
2. Alanine aminotransferase (ALT) ≥ 2.5 × ULN
3. Total Bilirubin > 2mg/dL 4. Participant has any concomitant non-colorectal cancer 5. Participant has any circumstances that, in the judgment of the Investigator, might make them not a suitable candidate for the study 6. Participants have already been enrolled in another investigational drug or device study within the past 6 months 7. Participants with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used 8. Participant is expected to receive or has received other methods for ureter identification during the surgery (e.g., ureteral stent placement, illuminated catheters, retrograde ICG injections) before the administration of IS-001 9. The duration of the surgery is expected to be less than 90 minutes as determined during preoperative planning.

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
Other: IS-001 Injection; Ureter visualization and delineation will be compared between white light (standard of care) and near-infrared (NIR) imaging mode after each of the two single intravenous injections of IS-001.	Drug: filricianine; IV injection of IS-001 filricianine with near infrared (NIR) imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 each independent reader at (a) the pelvic brim (PB) and (b) Inferior Mesenteric Artery (IMA) locations in Sensitive Firefly (SFF) mode compared to white light mode up to 30 minutes after the first IS-001 injection.	10 minutes after first injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length	Evaluate ureter length delineation at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the first IS-001 injection	30 minutes after the first injection
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 each independent reader at (a) PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the second IS-001 injection	30 miinutes after second injection
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length	Evaluate ureter length delineation at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the second IS-001 injection	30 minutes after second injection
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 the intra-operative surgeon's rating at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the first IS-001 injection	30 minutes after first IS-001 injection
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 each independent reader at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 45 minutes after the first and second IS-001injection	45 minutes after first injection
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 each independent reader at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 45 minutes after the first and second IS-001injection	45 minutes after second injection
Concordance of ureter visualization between independent readers	Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location	10 minutes after first injection
Concordance of ureter visualization between independent readers	Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location	30 minutes after first injection
Concordance of ureter visualization between independent readers	Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location	45 minutes after first injection
Concordance of ureter visualization between independent readers	Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location	10 minutes after second injection
Concordance of ureter visualization between independent readers	Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location	30 minutes after second injection
Concordance of ureter visualization between independent readers	Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location	45 minutes after second injection
Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment	Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment	10 minutes after first injection
Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment	Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment	30 minutes after first injection
Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment	Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment	45 minutes after first injection
Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment	Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment	10 minutes after second injection
Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment	Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment	30 minutes after second injection
Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment	Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment	45 minutes after second injection
Degree of concordance of ureter visualization within independent readers	Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location	10 minutes after first injection
Degree of concordance of ureter visualization within independent readers	Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location	30 minutes after first injection
Degree of concordance of ureter visualization within independent readers	Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location	45 minutes after first injection
Degree of concordance of ureter visualization within independent readers	Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location	10 minutes after second injection
Degree of concordance of ureter visualization within independent readers	Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location	30 minutes after second injection
Degree of concordance of ureter visualization within independent readers	Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location	45 minutes after second injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode	Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location	10 minutes after first injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode	Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location	30 minutes after first injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode	Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location	45 minutes after first injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode	Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location	10 minutes after second injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode	Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location	30 minutes after second injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode	Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location	45 minutes after second injection

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ISI-124804-CR-3

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