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NCT03937505 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Ureter Injury, sponsored by Intuitive Surgical.

Completed
Registry status
Phase 2
Development phase
94
Enrollment target
3
Study locations

NCT03937505 is a Phase 2 study of Ureter Injury that has completed, run by Intuitive Surgical. The registered enrollment target is 94 participants, roughly in line with the 97-participant average among 5 other Ureter Injury trials with a reported enrollment target. The trial reports 3 study locations across 2 states.

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The verdict

NCT03937505, a Phase 2 study of Ureter Injury, has completed, sponsored by Intuitive Surgical.

COMPLETED
Registry status
Phase 2
Development phase
94 participants
Enrollment target
3
Study locations

Study Summary

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.

Conditions Studied

Ureter Injury

Interventions

  • DRUG IS-001
  • DRUG No treatment

Study Locations (3)

Texas

  • St.David's Medical Center - Austin
  • Las Palmas Medical Center - El Paso

District of Columbia

  • George Washington University Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2019-05-28
Est. Completion 2021-07-22
Phase Phase 2

Sponsor

Intuitive Surgical

40 total trials

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What the Registry Record Tells You About NCT03937505

The ClinicalTrials.gov registry entry for NCT03937505 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 97-participant average among 5 other Ureter Injury trials with a reported enrollment target. The listed sponsor is Intuitive Surgical, which has 40 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ureter Injury appearing as the primary indexed condition, and to 2 interventions - of which IS-001 is the first listed.

NCT03937505 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Texas, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT03937505 about?

NCT03937505 is a clinical study titled "A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy". 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...

What is the current status of trial NCT03937505?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2019-05-28. Estimated completion is 2021-07-22.

What conditions does trial NCT03937505 study?

This clinical trial studies the following conditions: Ureter Injury.

What interventions are being tested in trial NCT03937505?

The interventions under investigation include: IS-001 (DRUG), No treatment (DRUG).

Who is sponsoring clinical trial NCT03937505?

This trial is sponsored by Intuitive Surgical, which has 40 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03937505 being conducted?

This trial has 3 study locations across District of Columbia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.