Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
Study Details
Study Description
Brief Summary
This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Capsule 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
Capsule endoscope used to view colonic mucosa
|
Outcome Measures
Primary Outcome Measures
- Positive Percent Agreement/Negative Percent Agreement [6 weeks]
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.
Secondary Outcome Measures
- Positive Percent Agreement/Negative Percent Agreement--secondary [6 weeks]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
At least 45-75 years of age
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Committed to undergo a colonoscopy, independent of this study
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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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Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
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Has contraindication for capsule endoscopy or colonoscopy
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Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
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Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
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History of incomplete colonoscopy
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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.)
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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 swallowing disorder, and/or ischemic bowel disease neuropathies 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 subject at greater risk for capsule endoscope retention
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Known allergy to ingredients used in bowel preparation and boosters
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Daily and/or regular narcotic use
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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 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
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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. WOCBP must have a negative urine pregnancy test at screening.
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Unable to follow or tolerate fasting, bowel preparation, and other study procedures
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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 or would affect the validity of the study results
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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, or the use of routine laxatives (other than fiber) to attain regular bowel movements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Scottsdale | Arizona | United States | 85259 |
| 2 | Kaiser Permanente Northern California | San Leandro | California | United States | 94577 |
| 3 | Advanced Research Institute | New Port Richey | Florida | United States | 34653 |
| 4 | Southwest Gastroenterology | New Lenox | Illinois | United States | 60451 |
| 5 | Digestive Health Specialists | Chelmsford | Massachusetts | United States | 01824 |
| 6 | West Michigan Clinical Research Center | Wyoming | Michigan | United States | 49519 |
| 7 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 8 | Hattiesburg GI Associates | Hattiesburg | Mississippi | United States | 39402 |
| 9 | Great Lakes Gastroenterology Research | Mentor | Ohio | United States | 44060 |
| 10 | Gastroenterology Consultants of SW Virginia | Roanoke | Virginia | United States | 24014 |
Sponsors and Collaborators
- Capso Vision, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLN-CVI-5794