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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.
The first phase of the study investigated the first generation of the capsule. The second generation capsule will be investigated in the final phase of enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Experimental | Subjects swallows the investigational device and undergoes a colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsule Endoscope | Device | Capsule endoscope used to view colonic mucosa |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive Percent Agreement/Negative Percent Agreement |
| 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Percent Agreement/Negative Percent Agreement--secondary |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Shields, MD | Gastroenterology Consultant at San Mateo County Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| Gastro Care Institute |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2024 | Jul 2, 2025 |
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Data collected from this study investigated the first generation CV-3 capsule.
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| 6 weeks |
| Lancaster |
| California |
| 93534 |
| United States |
| inSite Digestive Health Care | Los Gatos | California | 95032 | United States |
| Knowledge Research Center | Orange | California | 92868 | United States |
| Kaiser Permanente Northern California | San Leandro | California | 94577 | United States |
| Advanced Research Institute | New Port Richey | Florida | 34653 | United States |
| Digestive and Liver Center of Florida | Orlando | Florida | 32825 | United States |
| Advanced Gastroenterology Associates, LLC | Palm Harbor | Florida | 34684 | United States |
| Advanced Research Institute | St. Petersburg | Florida | 33710 | United States |
| Digestive Health Services | Downers Grove | Illinois | 60515 | United States |
| Northshore Center for Gastroenterology | Libertyville | Illinois | 60048 | United States |
| Suburban Gastroenterology | Naperville | Illinois | 60540 | United States |
| Southwest Gastroenterology | New Lenox | Illinois | 60451 | United States |
| Digestive Health Specialists | Chelmsford | Massachusetts | 01824 | United States |
| West Michigan Clinical Research Center | Wyoming | Michigan | 49519 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Hattiesburg GI Associates | Hattiesburg | Mississippi | 39402 | United States |
| NY total Medical Care, PC | Brooklyn | New York | 11215 | United States |
| Gastroenterology Group of Rochester | Rochester | New York | 14618 | United States |
| Great Lakes Gastroenterology Research | Mentor | Ohio | 44060 | United States |
| Tri-Cities Gastroenterology | Kingsport | Tennessee | 37663 | United States |
| Vilo Research Group | Houston | Texas | 77017 | United States |
| Gastroenterology Consultants of SW Virginia | Roanoke | Virginia | 24014 | United States |
| Prot_000.pdf |
| 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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| ID | Term |
|---|---|
| D053705 | Capsule Endoscopes |
| ID | Term |
|---|---|
| D020776 | Endoscopes, Gastrointestinal |
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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