CompletedNot Applicable

CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)

United States112 participantsStarted 2020-01-25

Plain-language summary

This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy.

Who can participate

Age range50 Years – 75 Years

SexALL

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Inclusion criteria

✓. Between the ages of 50 and 75 years old
✓. Subject meets at least one of the following criteria for increased risk for polyps:
✓. Recent history (within 6 months) of positive FIT/iFOBT or Cologuard test
✓. Older than 55 years of age, without prior history of colonoscopy
✓. Has had a positive colonoscopy ≥ 5 years prior to screening visit
✓. And/or having at least two of the following risk factors:
✓. No contraindication for capsule endoscopy or colonoscopy
✓. Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion

Exclusion criteria

✕. History of negative colonoscopy within the last 10 years
✕. History of incomplete colonoscopy
✕. Impaired cardiac function assessed as greater than NYHA Class II
✕. History of small- or large-bowel obstructive condition
✕. Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease 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 patient at greater risk for capsule endoscope retention
✕. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
✕. Known allergy to ingredients used in bowel preparation and boosters

What they're measuring

Efficacy Assessments

Timeframe: Day 1

Trial details

NCT IDNCT04246632

SponsorCapso Vision, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-25

View on ClinicalTrials.gov More Colonoscopy trials