Actively Recruiting
Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference
Led by Capso Vision, Inc. · Updated on 2026-05-08
330
Participants Needed
11
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: 1. prep for and swallow a study capsule and then 2. prep for and undergo a colonoscopy either the following day or 3-6 weeks later
CONDITIONS
Official Title
Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 and 75 years
- Willingness to undergo a colonoscopy
- Signed informed consent and agreement to release colonoscopy images and reports to the Sponsor
You will not qualify if you...
- Colonoscopy or CT colonography within the past 5 years showing no polyps
- Contraindications for capsule endoscopy or colonoscopy
- Suspected or diagnosed familial adenomatous polyposis, hereditary non-polyposis colon cancer, or high-risk genetic syndromes
- Suspected or diagnosed inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- History of incomplete colonoscopy
- Type I or uncontrolled Type II diabetes (HbA1C >6.4 in past 3 months or history of constipation or gastroparesis)
- Impaired cardiac function above NYHA Class II
- History of small or large bowel obstruction
- Known swallowing disorders, ischemic bowel disease neuropathies, or radiation enteritis
- NSAID enteropathy or strictures from regular NSAID use increasing risk of capsule retention
- Allergies to bowel preparation ingredients or boosters
- Daily or regular narcotic use
- Decompensated cirrhosis
- Prior abdominal radiation therapy
- Diagnosis of anorexia or bulimia
- History or suspicion of strictures, volvulus, intestinal obstruction, internal hernias, or abdominal surgeries excluding participation
- Known or suspected megacolon
- Scheduled MRI within 7 days after capsule ingestion
- Known slow gastric emptying or diagnosed gastroparesis
- Pregnant, nursing, or child-bearing potential without agreed contraception
- Unable to follow fasting, bowel preparation, or study procedures
- Medical or psychological conditions or illnesses making participation unsafe or affecting study validity
- Current enrollment in interventional or pharmaceutical clinical studies within last 30 days
- Chronic constipation defined as fewer than 3 bowel movements per week or routine laxative use (other than fiber)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
SB Gastro Clinical Research
Chula Vista, California, United States, 91910
Actively Recruiting
2
Gastro Care Institute
Lancaster, California, United States, 93534
Actively Recruiting
3
Knowledge Research Center
Orange, California, United States, 92868
Actively Recruiting
4
Advanced Research Institute
St. Petersburg, Florida, United States, 33710
Actively Recruiting
5
Digestive Health Services
Downers Grove, Illinois, United States, 60515
Actively Recruiting
6
Gastroenterology and Internal Medicine Specialists
Lake Barrington, Illinois, United States, 60010
Actively Recruiting
7
Northshore Center for Gastroenterology
Libertyville, Illinois, United States, 60048
Actively Recruiting
8
Suburban Gastroenterology
Naperville, Illinois, United States, 60540
Actively Recruiting
9
Southwest Gastroenterology
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
10
Gastroenterology Group of Rochester
Rochester, New York, United States, 14618
Actively Recruiting
11
Great Lakes Gastroenterology Research
Mentor, Ohio, United States, 44060
Actively Recruiting
Research Team
T
Taylor Williamsen Principle CRA/Study Lead
CONTACT
R
Rebecca Petersen Sr. Director of Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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