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Colonic PolypNCT04607746

Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

A study testing Capsule Endoscope in people with Colonic Polyp, run by Capso Vision, Inc. at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Colonic Polyp
What is being tested?
Capsule Endoscope
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,337 participants
Where
23 sitesUnited States
Study dates
6 Jan 2021to 14 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 45-75 years of age
  • Committed to undergo a colonoscopy, independent of this study
  • Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor

Who cannot join

  • Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
  • Has contraindication for capsule endoscopy or colonoscopy
  • Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
  • Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
  • History of incomplete colonoscopy
  • Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C>6.4 within the past 3 months and/or with history of constipation or gastroparesis.)
Show all 24Show fewer
  • Impaired cardiac function assessed as greater than NYHA Class II
  • History of small- or large-bowel obstructive condition
  • Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
  • Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the subject at greater risk for capsule endoscope retention
  • Known allergy to ingredients used in bowel preparation and boosters
  • Daily and/or regular narcotic use
  • Decompensated cirrhosis
  • Prior abdominal radiation therapy
  • Diagnosis of anorexia or bulimia
  • History of or suspicion of any of the following: strictures, volvulus or intestinal obstruction, or internal hernias or abdominal surgeries that the Investigator believes should exclude the patient from study participation
  • Known or suspected megacolon
  • Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
  • Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
  • Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. WOCBP must have a negative urine pregnancy test at screening.
  • Unable to follow or tolerate fasting, bowel preparation, and other study procedures
  • Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study or would affect the validity of the study results
  • Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
  • Chronic constipation as defined by <3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • NY total Medical Care, PC

    Brooklyn, New York, 11215

  • Digestive Health Specialists

    Chelmsford, Massachusetts, 01824

  • Digestive Health Services

    Downers Grove, Illinois, 60515

  • Hattiesburg GI Associates

    Hattiesburg, Mississippi, 39402

  • Vilo Research Group

    Houston, Texas, 77017

  • Tri-Cities Gastroenterology

    Kingsport, Tennessee, 37663

  • Gastro Care Institute

    Lancaster, California, 93534

  • Northshore Center for Gastroenterology

    Libertyville, Illinois, 60048

  • inSite Digestive Health Care

    Los Gatos, California, 95032

  • Great Lakes Gastroenterology Research

    Mentor, Ohio, 44060

  • Suburban Gastroenterology

    Naperville, Illinois, 60540

  • Southwest Gastroenterology

    New Lenox, Illinois, 60451

  • Advanced Research Institute

    New Port Richey, Florida, 34653

  • Knowledge Research Center

    Orange, California, 92868

  • Digestive and Liver Center of Florida

    Orlando, Florida, 32825

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Gastroenterology Consultants of SW Virginia

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Gastroenterology Group of Rochester

    Rochester, New York, 14618

  • Kaiser Permanente Northern California

    San Leandro, California, 94577

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Advanced Research Institute

    St. Petersburg, Florida, 33710

  • West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: Prospective Open Label, Pivotal Study of the Accuracy of The CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.

Read the detailed description

The first phase of the study investigated the first generation of the capsule. The second generation capsule will be investigated in the final phase of enrollment.

Conditions
Colonic Polyp
Being tested
Capsule Endoscope
Medical subject headings
Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capsule EndoscopeDevice

    Capsule endoscope used to view colonic mucosa

Study groups in NCT04607746
Study groupRoleWhat they receive
Single arm studyExperimentalSubjects swallows the investigational device and undergoes a colonoscopy
Receives: Device: Capsule Endoscope

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive Percent Agreement/Negative Percent Agreement

    1. Positive Percent Agreement (PPA) of study device (SD) with computer assisted detection (CADe) for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is >= 6mm, where a match is considered to have occurred if a polyp detected by the device is assessed as having a size within plus or minus 50% of the size of the polyp detected by OC and as having a location within the same or an adjacent colon segment.
    2. Negative percent agreement (NPA) of the SD with CADe for not detecting any polyp >= 6mm in a subject for whom OC did not detect any polyp >=6mm.

    Measured: 6 weeks

Secondary outcomes (1)

  1. Positive Percent Agreement/Negative Percent Agreement--secondary

    1. PPA...relying on CADe versus not using CADe for detecting the presence....if that polyp is ≥ 6 mm, where there is a match..
    2. NPA....relying on CADe versus not using CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm.
    3. PPA with CADe for detecting the presence...if that polyp is ≥ 10 mm, where there is a match..
    4. NPA with CADe for not detecting any polyp ≥ 10 mm in a subject for whom OC did not detect any polyp ≥ 10 mm.
    5. Sensitivity with CADe for detecting advanced neoplasia \& is assessed to be =>10 mm in size.
    6. Specificity with CADe for not detecting any lesion ≥ 10 mm when OC did not detect any advanced neoplasia.
    7. PPA with CADe if that polyp is ≥ 6 mm and < 10 mm
    8. Sensitivity with CADe for polyp ≥ 6 mm.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start6 Jan 2021
  3. Primary completion14 Feb 2025
  4. Study completion14 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Data collected from this study investigated the first generation CV-3 capsule.
Masking
None (open label)
Enrolment
1,337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607746
Sponsor's protocol ID
CLN-CVI-5794
Status last verified
Jul 2025
First submitted
23 Oct 2020
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Capsule Endoscope in people with Colonic Polyp, run by Capso Vision, Inc. at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Percent Agreement/Negative Percent Agreement (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607746.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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