Recruiting
Phase 3

IS-001

Sponsor:

Intuitive Surgical

Code:

NCT07346066

Conditions

Ureter Injury

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

filricianine

Study Details

Brief summary:

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

Conditions

Ureter Injury

Study ID

NCT07346066

Start date

May 14, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

146 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

filricianine

IV injection of IS-001 filricianine with near infrared (NIR) imaging

Primary outcome measure

  • 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. [ Time Frame: 10 minutes after first injection ]

Central Contacts and Locations

Central contacts

Clinical Project Manager

4085232100info.is-001@intusurg.com

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Contacts

Principal Investigator:

Babak Rad, MD

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Principal Investigator:

Haddon Pantel, MD

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Principal Investigator:

Marco Ferrara, MD

Mountain View Hospital

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

Principal Investigator:

Garrett Friedman, MD

St David's North Austin Medical Center

Recruiting

Austin, Texas, United States, 78758

Contacts

Principal Investigator:

Thiru Lakshman, MD

HCA Houston Healthcare Medical Center

Recruiting

Houston, Texas, United States, 77004

Contacts

Principal Investigator:

Eric Haas, MD

More Information

Sponsor

Intuitive Surgical

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intuitive Surgical on 2026-08-05.