NCT03937505 is a Phase 2 clinical trial of IS-001 in Ureter Injury, sponsored by Intuitive Surgical.

Who is sponsoring NCT03937505?

NCT03937505 is sponsored by Intuitive Surgical.

What drugs are being tested in NCT03937505?

Interventions in NCT03937505: IS-001, No treatment.

What condition does NCT03937505 study?

NCT03937505 studies Ureter Injury.

Is NCT03937505 still recruiting?

NCT03937505 is currently completed. Last updated 5 August 2021.

Last reviewed 2021-08-05 · How we verify

NCT03937505

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy

Completed Phase 2 Last updated 5 August 2021

What this trial tests

Phase 2 trial testing IS-001 in Ureter Injury in 94 participants. Completed in 22 July 2021.

Timeline

28 May 2019

Primary endpoint
8 July 2021

22 July 2021

Quick facts

Lead sponsor	Intuitive Surgical
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	94
Start date	28 May 2019
Primary completion	8 July 2021
Estimated completion	22 July 2021
Sites	3 locations across United States

Drugs / interventions tested

IS-001 — full drug profile →
No treatment — full drug profile →

Conditions studied

Ureter Injury — all drugs for Ureter Injury →

Sponsor

Intuitive Surgical — full company profile →

Who can join

Adults 18 to 75, female only, with Ureter Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Fluorescence Image-Guided Surgery - a Perspective on Contrast Agent Development.
Barth CW, Gibbs SL. · · 2020 · cited 79× · PMID 32255887 · DOI 10.1117/12.2545292

Verify or expand the search:

Other trials of IS-001

Trials testing the same drug.

NCT05954767 — IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery · Phase 3 · completed
NCT05769257 — A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery · Phase 2 · completed

Other recruiting trials for Ureter Injury

Currently open trials in the same condition.

NCT06987760 — Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones · NA · recruiting
NCT06085183 — Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment · Phase 4 · recruiting
NCT06054880 — Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency · Phase 4 · recruiting

Other Intuitive Surgical trials

Trials by the same sponsor.

NCT07346066 — IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery · Phase 3 · not yet recruiting
NCT07259759 — JURA Study - Observational First-in-human Feasibility Study · completed
NCT06434727 — Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures. · completed
NCT06308120 — A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis · NA · active not recruiting
NCT05954767 — IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03937505 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Intuitive Surgical
Last refreshed: 5 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03937505.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing