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

Completed · Not applicable

Conditions studied: Colonoscopy

In brief

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.

Key facts

Study ID

NCT04246632

Run by

Capso Vision, Inc.

People needed

112

Starts

2020-01-25

Expected to finish

2021-03-15

Last updated by the study team

2021-08-06

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Current smoker
• BMI of ≥30
• Family history (blood relative) of colorectal cancer
• Sedentary lifestyle
• Low fiber/ high fat diet
• No contraindication for capsule endoscopy or colonoscopy
• Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion
• Choose to participate and must have signed the IRB-approved informed-consent document and agreed to release colonoscopy images and results report to Sponsor

You may not qualify if…

• 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
• Daily and/or regular use of narcotics
• Known or suspected AIDS
• Uncompensated cirrhosis
• Prior abdominal radiation therapy
• Diagnosis of anorexia or bulimia
• History of or suspicion for: strictures, volvulus or intestinal obstruction; internal hernias or abdominal surgeries that the Investigator considers as an exclusion
• 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. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening.
• 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
• 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 for at least 3 months prior to Screening, or the use of routine laxatives (other than fiber) to attain r regular bowel movements for at least 3 months prior to Screening
• History of diabetes in which the prolonged fasting schedule could impose additional safety risks, as determined by the investigator

Where it is running

• Silicon Valley Research Institute, Inc. — San Jose, California, United States
• CapsoVision Research Clinic — Saratoga, California, United States
• West Michigan Clinical Research Center — Wyoming, Michigan, United States

Full record on ClinicalTrials.gov

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