What this study is
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
What's being tested
- Capsule swallow
Intervention · DEVICE
Participant will swallow the investigational device
Study details
- 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
- Sponsor
- Capso Vision, Inc.
- Conditions
- Colonic Polyps
- Enrolling
- 330 people
- Starts
- 2025-06-26
- Est. completion
- 2026-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 45-75 years of age
- Committed to undergo a colonoscopy.
- Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor
You can't join if
- 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 of child-bearing potential and does not agree to practice medically acceptable methods of contraception. Women of child bearing potential (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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (11)
11 openSB Gastro Clinical Research
Chula Vista, California, United States
- Study Coordinator · Contact619-513-3372judy@gastrosb.com
- Erick Alayo, M.D. · Principal investigator
RecruitingGastro Care Institute
Lancaster, California, United States
- Lead Study Coordinator · Contact661-529-7550Rvargas@gciav.com
- Kumaravel Perumalsamy, M.D. · Principal investigator
RecruitingKnowledge Research Center
Orange, California, United States
- Regulatory/Study Coordinator · Contact657-247-0087j.bermudez@knowledgeresearchcenter.com
- Alla Abousaif, M.D. · Principal investigator
RecruitingAdvanced Research Institute
St. Petersburg, Florida, United States
- Study Coordinator · Contact727-835-3261lauren.scott@ariclinical.com
- Jatin Bidani, M.D. · Principal investigator
RecruitingDigestive Health Services
Downers Grove, Illinois, United States
- Site Manager · Contact(708) 253-5810devang.shah@avicennaclinical.com
- Rockford Yapp, M.D. · Principal investigator
RecruitingGastroenterology and Internal Medicine Specialists
Lake Barrington, Illinois, United States
- Site Manager · Contact708-253-5810devang.shah@avicennaclinical.com
- Nicole Gentile, M.D. · Principal investigator
RecruitingNorthshore Center for Gastroenterology
Libertyville, Illinois, United States
- Site Manager · Contact708-253-5810devang.shah@avicennaclinical.com
- Sean Lee, M.D. · Principal investigator
RecruitingSuburban Gastroenterology
Naperville, Illinois, United States
- Site Manager · Contact708-253-5810devang.shah@avicennaclinical.com
- Thomas Couri, M.D. · Principal investigator
RecruitingSouthwest Gastroenterology
Oak Lawn, Illinois, United States
- Site Manager · Contact708-253-5810devang.shah@avicennaclinical.com
- Kamran Ayub, M.D. · Principal investigator
RecruitingGastroenterology Group of Rochester
Rochester, New York, United States
- Lead Study Coordinator · Contact585-278-1116bvasciannie@ggr1.com
- Jonathan Wilmot, M.D. · Principal investigator
RecruitingGreat Lakes Gastroenterology Research
Mentor, Ohio, United States
- Lead Clinical Research Coordinator · Contact216-387-4966susand@greatlakesgastro.net
- Keith Friedenberg, M.D. · Principal investigator
Recruiting
Study team
Sponsor
Capso Vision, Inc.
Study ID CLN-CVI-5794 2nd Generation
Principal investigator
Suejin Kim Study PI, M.D.
CONTACT
Rebecca Petersen Sr. Director of Clinical Affairs
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.