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Note: This is the same study protocol as NCT04607746 with slight changes to how the videos will be read and a 2nd generation capsule is being studied.
The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps and to show that AI-based CADe improves the polyp-detection accuracy and efficiency of capsule video readers. It will use colonoscopy results as a reference.
The participant will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A new capsule design is being used from that of the first phase of the study. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsule swallow | Device | Participant will swallow the investigational device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive Percentage Agreement | • Positive Percent Agreement (PPA) of the study device with computer assisted detection (CADe) for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is ≥ 6 mm, where a match is considered to have occurred if a polyp detected by the device is assessed as having a size within plus or minus 50% of the size of the polyp detected by OC and as having a location within the same or an adjacent colon segment. | From capsule swallow to Colonoscopy - up to 6 weeks |
| Negative Percentage Agreement | • Negative percent agreement (NPA) of the study device with CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm. | From Capsule swallow to colonoscopy - Up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taylor Williamsen Principle CRA/Study Lead | Contact | 815-861-9575 | taylor.williamsen@capsovision.com | |
| Rebecca Petersen Sr. Director of Clinical Affairs | Contact | 510-566-8824 | rebecca.petersen@capsovision.com |
| Name | Affiliation | Role |
|---|---|---|
| Suejin Kim Study PI, M.D. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SB Gastro Clinical Research | Recruiting | Chula Vista | California | 91910 | United States |
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| Gastro Care Institute | Recruiting | Lancaster | California | 93534 | United States |
|
| Knowledge Research Center | Recruiting | Orange | California | 92868 | United States |
|
| Advanced Research Institute | Recruiting | St. Petersburg | Florida | 33710 | United States |
|
| Digestive Health Services | Recruiting | Downers Grove | Illinois | 60515 | United States |
|
| Gastroenterology and Internal Medicine Specialists | Recruiting | Lake Barrington | Illinois | 60010 | United States |
|
| Northshore Center for Gastroenterology | Recruiting | Libertyville | Illinois | 60048 | United States |
|
| Suburban Gastroenterology | Recruiting | Naperville | Illinois | 60540 | United States |
|
| Southwest Gastroenterology | Recruiting | Oak Lawn | Illinois | 60453 | United States |
|
| Gastroenterology Group of Rochester | Recruiting | Rochester | New York | 14618 | United States |
|
| Great Lakes Gastroenterology Research | Recruiting | Mentor | Ohio | 44060 | United States |
|
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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