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NCT04574401 · ClinicalTrials.gov registry record · Phase 1

A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy

A Phase 1 study of Prostate Cancer, sponsored by Intuitive Surgical.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT04574401: Completed Phase 1 study of Prostate Cancer, sponsored by Intuitive Surgical.

NCT04574401 is a Phase 1 study of Prostate Cancer that has completed, run by Intuitive Surgical. The registered enrollment target is 24 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04574401, a Phase 1 study of Prostate Cancer, has completed, sponsored by Intuitive Surgical.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.

Conditions Studied

Interventions

  • DRUG IS-002

Study Locations (1)

California

  • UCSF Medical Center, Mission Bay - San Francisco

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-10-10
Est. Completion 2021-09-20
Phase Phase 1

Sponsor

Intuitive Surgical

40 total trials

What the Registry Record Tells You About NCT04574401

The ClinicalTrials.gov registry entry for NCT04574401 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Intuitive Surgical, which has 40 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which IS-002 is the first listed.

NCT04574401 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04574401 about?

NCT04574401 is a clinical study titled "A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy". This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgica...

What is the current status of trial NCT04574401?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-10-10. Estimated completion is 2021-09-20.

What conditions does trial NCT04574401 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT04574401?

The interventions under investigation include: IS-002 (DRUG).

Who is sponsoring clinical trial NCT04574401?

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

Where is trial NCT04574401 being conducted?

This trial has 1 study location across California. 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

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, the data changelog, or report a data error.