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

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

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

Conditions
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Colonic Polyp

Intervention / Treatment
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* Device: Capsule Endoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 (Uncontrolled defined as HbA1C>6.4 within the past 3 months and/or with 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 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsule<br>Participants will swallow the capsule for imaging prior to completing colonoscopy. Capsule swallow may be 1 day prior or 3-6 weeks prior to colonoscopy. | Device: Capsule Endoscope<br>* Capsule endoscope used to view colonic mucosa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Percent Agreement/Negative Percent Agreement | Positive Percent Agreement (PPA) of CapsoCam® Colon (CV-3) for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is ≥ 6 mm Negative Percent Agreement (NPA) of the device for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Percent Agreement/Negative Percent Agreement--secondary | PPA of the device for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is, ≥ 6 mm and < 10 mm, or ≥ 10 mm (same matching rules) NPA of the device for not detecting any polyp ≥ 10 mm in a subject for whom OC did not detect any polyp ≥ 6 mm and < 10 mm or ≥ 10 mm. PPA of the device for detecting the presence of a polyp ≥ 6 mm in a subject with OC as the reference (without regard to polyp matching). PPA of the device for detecting the presence in a subject of a polyp ≥ 6 mm and < 10 mm with OC as the reference (without regard to polyp matching). PPA of the device for detecting the presence in a subject of the largest sessile serrated polyp detected by OC if that polyp is ≥ 6 mm, (same matching rules) PPA of the device for detecting the presence in a subject of a cancerous polyp biopsied by OC and diagnosed by histopathology, (same matching rules as above) | 6 weeks |