Clinical trial NCT04607746: Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
Official title: Prospective Open Label, Pivotal Study of the Accuracy of The CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Polyp
Lead sponsor: Capso Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 1200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: Inclusion Criteria:

1. At least 45-75 years of age
2. Committed to undergo a colonoscopy, independent of this study
3. 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:

1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
2. Has contraindication for capsule endoscopy or colonoscopy
3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
5. History of incomplete colonoscopy
6. 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.)
7. Impaired cardiac function assessed as greater than NYHA Class II
8. History of small- or large-bowel obstructive condition
9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
10. 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
11. Known allergy to ingredients used in bowel preparation and boosters
12. Daily and/or regular narcotic use
13. Decompensated cirrhosis
14. Prior abdominal radiation therapy
15. Diagnosis of anorexia or bulimia
16. 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
17. Known or suspected megacolon
18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
20. 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.
21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
22. 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
23. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
24. Chronic constipation as defined by \<3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements

Primary outcomes:
measure: Positive Percent Agreement/Negative Percent Agreement
timeFrame: 6 weeks
Secondary outcomes:
measure: Positive Percent Agreement/Negative Percent Agreement--secondary
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Gastro Care Institute
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente Northern California
state: California
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Downers Grove
country: United States
facility: Digestive Health Services
state: Illinois
city: Libertyville
country: United States
facility: Northshore Center for Gastroenterology
state: Illinois
city: Naperville
country: United States
facility: Suburban Gastroenterology
state: Illinois
city: New Lenox
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg GI Associates
state: Mississippi
city: Rochester
country: United States
facility: Gastroenterology Group of Rochester
state: New York
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research
state: Ohio
city: Kingsport
country: United States
facility: Tri-Cities Gastroenterology
state: Tennessee
city: Roanoke
country: United States
facility: Gastroenterology Consultants of SW Virginia
state: Virginia
Study officials:
affiliation: Private Practice
name: David Shields, MD
role: PRINCIPAL_INVESTIGATOR
References: