CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open label Single arm study, all subjects receive device |
Device: CapsoCam Colon Capsule Endoscopy
CapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults.
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Outcome Measures
Primary Outcome Measures
- Efficacy Assessments [Day 1]
Determine the Accuracy of CapsoCam® to detect and measure size of colon polyps relative to the colonoscopy procedure.
Secondary Outcome Measures
- Safety Assessments: Incidence of device related serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) [Day 1-3]
All adverse events including SAEs/UADEs will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be reported. A serious adverse event is one that meets the definition outlined in Section 8 of this protocol.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Between the ages of 50 and 75 years old
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Subject meets at least one of the following criteria for increased risk for polyps:
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Recent history (within 6 months) of positive FIT/iFOBT or Cologuard test
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Older than 55 years of age, without prior history of colonoscopy
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Has had a positive colonoscopy ≥ 5 years prior to screening visit
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And/or having at least two of the following risk factors:
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Current smoker
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BMI of ≥30
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Family history (blood relative) of colorectal cancer
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Sedentary lifestyle
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Low fiber/ high fat diet
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No contraindication for capsule endoscopy or colonoscopy
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Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion
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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:
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History of negative colonoscopy within the last 10 years
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History of incomplete colonoscopy
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Impaired cardiac function assessed as greater than NYHA Class II
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History of small- or large-bowel obstructive condition
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Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease and/or radiation enteritis
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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
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Unable to follow or tolerate fasting, bowel preparation, and other study procedures
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Known allergy to ingredients used in bowel preparation and boosters
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Daily and/or regular use of narcotics
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Known or suspected AIDS
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Uncompensated cirrhosis
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Prior abdominal radiation therapy
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Diagnosis of anorexia or bulimia
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History of or suspicion for: strictures, volvulus or intestinal obstruction; internal hernias or abdominal surgeries that the Investigator considers as an exclusion
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Known or suspected megacolon
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Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
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Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
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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.
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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
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Are currently enrolled in, or participated in within the last 30 days, another clinical study
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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
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History of diabetes in which the prolonged fasting schedule could impose additional safety risks, as determined by the investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Silicon Valley Research Institute, Inc. | San Jose | California | United States | 95116 |
| 2 | CapsoVision Research Clinic | Saratoga | California | United States | 95070 |
| 3 | West Michigan Clinical Research Center | Wyoming | Michigan | United States | 49519 |
Sponsors and Collaborators
- Capso Vision, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLN-CVI-5248