Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT07089615 · View on ClinicalTrials.gov ↗

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

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

4 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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Capso Vision, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07089615 reports 11 study locations spanning 5 distinct geographic areas — top geographies include Illinois, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07089615?

The interventions under investigation include: Capsule swallow (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07089615?

This trial is sponsored by Capso Vision, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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