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NCT07089615 · ClinicalTrials.gov registry record · NA

Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

A NA study of Colonic Polyps, sponsored by Capso Vision.

Recruiting
Registry status
NA
Development phase
330
Enrollment target
11
Study locations

NCT07089615 is a NA study of Colonic Polyps that is actively recruiting participants, run by Capso Vision. The registered enrollment target is 330 participants, below the 735-participant average among 6 other Colonic Polyps trials with a reported enrollment target (55% lower). The trial reports 11 study locations across 5 states.

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The verdict

NCT07089615, a NA study of Colonic Polyps, is actively recruiting participants, sponsored by Capso Vision.

RECRUITING
Registry status
NA
Development phase
330 participants
Enrollment target
11
Study locations

Study Summary

Note: This is the same study protocol as NCT04607746 with slight changes to how the videos will be read and a 2nd generation capsule is being studied. The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps and to show that AI-based CADe improves the polyp-detection accuracy and efficiency of capsule video readers. It will use colonoscopy results as a reference. The participant will: 1. prep for and swallow a study capsule and then 2. prep for and undergo a colonoscopy either the following day or 3-6 weeks later

Conditions Studied

Colonic Polyps

Interventions

  • DEVICE Capsule swallow

Study Locations (11)

Illinois

  • Digestive Health Services - Downers Grove
  • Gastroenterology and Internal Medicine Specialists - Lake Barrington
  • Northshore Center for Gastroenterology - Libertyville
  • Suburban Gastroenterology - Naperville
  • Southwest Gastroenterology - Oak Lawn

California

  • SB Gastro Clinical Research - Chula Vista
  • Gastro Care Institute - Lancaster
  • Knowledge Research Center - Orange

Florida

  • Advanced Research Institute - St. Petersburg

New York

  • Gastroenterology Group of Rochester - Rochester

Ohio

  • Great Lakes Gastroenterology Research - Mentor

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2025-06-26
Est. Completion 2026-01
Phase NA

Sponsor

Capso Vision

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07089615

The ClinicalTrials.gov registry entry for NCT07089615 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 735-participant average among 6 other Colonic Polyps trials with a reported enrollment target (55% lower). The listed sponsor is Capso Vision, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colonic Polyps appearing as the primary indexed condition, and to 1 intervention - of which Capsule swallow is the first listed.

NCT07089615 reports 11 study locations spanning 5 distinct geographic areas - top geographies include Illinois, California, Florida.

Frequently Asked Questions

What is clinical trial NCT07089615 about?

NCT07089615 is a clinical study titled "Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference". Note: This is the same study protocol as NCT04607746 with slight changes to how the videos will be read and a 2nd generation capsule is being studied. The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps...

What is the current status of trial NCT07089615?

This trial is currently recruiting. It is a NA study. The enrollment target is 330 participants. The study started on 2025-06-26. Estimated completion is 2026-01.

What conditions does trial NCT07089615 study?

This clinical trial studies the following conditions: Colonic Polyps.

What interventions are being tested in trial NCT07089615?

The interventions under investigation include: Capsule swallow (DEVICE).

Who is sponsoring clinical trial NCT07089615?

This trial is sponsored by Capso Vision, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07089615 being conducted?

This trial has 11 study locations across California, Florida, Illinois, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.