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

Part of paid clinical trials in Newport Beach, California.

Sponsor
Intuitive Surgical
Study ID
NCT07346066
Phase
PHASE3
Status
Recruiting
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Conditions

  • Ureter Injury

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Jan 16, 2026
Start date
May 14, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
146 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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.

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

Locations (9)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Vianh Truong
[email protected]
949-764-5597
Babak Rad, MD (PRINCIPAL_INVESTIGATOR)
Yale New Haven HospitalNew HavenConnecticut06510
Kyra Jersey
[email protected]
203-688-4242
Haddon Pantel, MD (PRINCIPAL_INVESTIGATOR)
Orlando HealthOrlandoFlorida32806
Patty Camacho
[email protected]
321-842-4130
Marco Ferrara, MD (PRINCIPAL_INVESTIGATOR)
Antonio Caycedo, MD (SUB_INVESTIGATOR)
Mountain View HospitalLas VegasNevada89128
Coral Rodriguez
[email protected]
702-255-5000
Garrett Friedman, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UnversityColumbusOhio43210
Chandler Lowe
[email protected]
(614) 293-9955
Emily Huang, MD (PRINCIPAL_INVESTIGATOR)
Philip Bauer, MD (SUB_INVESTIGATOR)
Kettering HealthKetteringOhio45429
Clinical Research Coordinator
855-500-2873
Minia Hellan, MD (PRINCIPAL_INVESTIGATOR)
St David's North Austin Medical CenterAustinTexas78758
Krishna Saini
[email protected]
5125448070
Thiru Lakshman, MD (PRINCIPAL_INVESTIGATOR)
HCA Houston Healthcare Medical CenterHoustonTexas77004
Jimena Alcocer-Barrios
[email protected]
713-527-5000
Eric Haas, MD (PRINCIPAL_INVESTIGATOR)
Jean-Paul LeFave, MD (SUB_INVESTIGATOR)
MultiCare Tacoma General HospitalTacomaWashington98405
Stacey Macon
[email protected]
253-403-0791
Laila Rashidi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Newport Beach, CA

By research site
Hoag Memorial Hospital Presbyterian· Newport Beach, CAYale New Haven Hospital· New Haven, CTOrlando Health· Orlando, FLMountain View Hospital· Las Vegas, NVThe Ohio State Unversity· Columbus, OHKettering Health· Kettering, OH

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