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

  • STATUS
    Recruiting
  • End date
    Mar 4, 2022
  • participants needed
    1500
  • sponsor
    Capso Vision, Inc.
Updated on 4 July 2021
colonoscopy

Summary

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

Details
Condition COLONIC POLYP, Colon Polyps
Treatment Capsule Endoscope, Capsule Endoscope
Clinical Study IdentifierNCT04607746
SponsorCapso Vision, Inc.
Last Modified on4 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 50-75 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

Exclusion Criteria

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 (HbA1C>6.4 within the past 3 months) with a history of constipation or gastroparesis
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
Uncompensated 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, or participated in within the last 30 days, another 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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