Actively Recruiting
Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam4 Colon (CV-3) in Detecting Colonic Polyps Using Colonoscopy as Reference
Led by Capso Vision, Inc. · Updated on 2026-05-08
330
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the CapsoCam4 Colon (CV-3) endoscope system in detecting colonic polyps. This study aims to determine whether the AI-based computer-aided detection (CADe) feature improves the accuracy and efficiency of reading capsule videos. Colonoscopy results will be used as the reference standard to compare findings from the capsule system. Participants will prepare for and swallow the study capsule, which includes a new second-generation design. After the capsule procedure, participants will undergo a colonoscopy either the following day or between 3 to 6 weeks later. This allows researchers to compare the capsule findings with the colonoscopy results. During the study, participants will be monitored from the time of the capsule swallow up to the colonoscopy within 6 weeks. The main outcomes measured include the positive and negative percentage agreement between the capsule system and the colonoscopy in detecting polyps. Participants will complete required preparation and procedures, and safety and effectiveness data will be collected throughout the study period.
CONDITIONS
Brief 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
- Committed to undergo a colonoscopy
- Provided signed informed consent and agreed to release colonoscopy images and results to the Sponsor
You will not qualify if you...
- Colonoscopy or CT-colonography within 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 syndrome
- 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 with recent HbA1C >6.4 or related symptoms
- Cardiac function worse than NYHA Class II
- History of small or large bowel obstruction
- Known swallowing disorder, ischemic bowel disease neuropathies, or radiation enteritis
- NSAID enteropathy or strictures from regular NSAID use causing risk for capsule retention
- Allergy 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 deemed exclusionary
- Known or suspected megacolon
- Scheduled MRI within 7 days after capsule ingestion
- Known slow gastric emptying or gastroparesis
- Pregnant, nursing, or of childbearing potential not practicing contraception; negative pregnancy test required
- Unable to follow or tolerate fasting, bowel preparation, or study procedures
- Significant medical or psychological conditions making participation unsafe or invalid
- Currently enrolled in other interventional clinical studies or pharmaceutical trials within last 30 days
- Chronic constipation defined as fewer than 3 bowel movements per week or regular laxative use (other than fiber) to maintain regular bowel movements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants swallow the investigational capsule device for colonic polyp detection.
1 visit for capsule swallow and follow-up assessments
Duration - Up to 6 weeks
Participants undergo colonoscopy as a reference to evaluate the capsule device's accuracy.
1 colonoscopy visit
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
R
Rebecca Petersen Sr. Director of Clinical Affairs
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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