Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
- Conditions
- Colonic Polyp
- Interventions
- Device: Capsule Endoscope
- Registration Number
- NCT04607746
- Lead Sponsor
- Capso Vision, Inc.
- Brief Summary
This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Capsule Capsule Endoscope 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.
- Primary Outcome Measures
Name Time Method Positive Percent Agreement/Negative Percent Agreement 6 weeks 1. Positive Percent Agreement (PPA) of study device (SD) 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 \>= 6mm, 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.
2. Negative percent agreement (NPA) of the SD with CADe for not detecting any polyp \>= 6mm in a subject for whom OC did not detect any polyp \>=6mm.
- Secondary Outcome Measures
Name Time Method Positive Percent Agreement/Negative Percent Agreement--secondary 6 weeks 1. PPA...relying on CADe versus not using CADe for detecting the presence....if that polyp is ≥ 6 mm, where there is a match..
2. NPA....relying on CADe versus not using CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm.
3. PPA with CADe for detecting the presence...if that polyp is ≥ 10 mm, where there is a match..
4. NPA with CADe for not detecting any polyp ≥ 10 mm in a subject for whom OC did not detect any polyp ≥ 10 mm.
5. Sensitivity with CADe for detecting advanced neoplasia \& is assessed to be =\>10 mm in size.
6. Specificity with CADe for not detecting any lesion ≥ 10 mm when OC did not detect any advanced neoplasia.
7. PPA with CADe if that polyp is ≥ 6 mm and \< 10 mm
8. Sensitivity with CADe for polyp ≥ 6 mm.
Trial Locations
- Locations (14)
Hattiesburg GI Associates
🇺🇸Hattiesburg, Mississippi, United States
Gastro Care Institute
🇺🇸Lancaster, California, United States
Kaiser Permanente Northern California
🇺🇸San Leandro, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
Northshore Center for Gastroenterology
🇺🇸Libertyville, Illinois, United States
Digestive Health Services
🇺🇸Downers Grove, Illinois, United States
Suburban Gastroenterology
🇺🇸Naperville, Illinois, United States
Southwest Gastroenterology
🇺🇸New Lenox, Illinois, United States
West Michigan Clinical Research Center
🇺🇸Wyoming, Michigan, United States
Great Lakes Gastroenterology Research
🇺🇸Mentor, Ohio, United States
Gastroenterology Group of Rochester
🇺🇸Rochester, New York, United States
Gastroenterology Consultants of SW Virginia
🇺🇸Roanoke, Virginia, United States
Tri-Cities Gastroenterology
🇺🇸Kingsport, Tennessee, United States