Colonic PolypsNCT07089615
Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference
A study testing Capsule swallow in people with Colonic Polyps, run by Capso Vision, Inc. at 11 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Capsule swallow
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 11 sitesUnited States
- Study dates
- 26 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rebecca Petersen Sr. Director of Clinical Affairs contact
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
SB Gastro Clinical Research
Chula Vista, California, 91910
Study Coordinator, 619-513-3372, judy@gastrosb.com
Erick Alayo, M.D.
- Recruiting
Digestive Health Services
Downers Grove, Illinois, 60515
Site Manager, (708) 253-5810, devang.shah@avicennaclinical.com
Rockford Yapp, M.D.
- Recruiting
Gastroenterology and Internal Medicine Specialists
Lake Barrington, Illinois, 60010
Site Manager, 708-253-5810, devang.shah@avicennaclinical.com
Nicole Gentile, M.D.
- Recruiting
Gastro Care Institute
Lancaster, California, 93534
Lead Study Coordinator, 661-529-7550, Rvargas@gciav.com
Kumaravel Perumalsamy, M.D.
- Recruiting
Northshore Center for Gastroenterology
Libertyville, Illinois, 60048
Site Manager, 708-253-5810, devang.shah@avicennaclinical.com
Sean Lee, M.D.
- Recruiting
Great Lakes Gastroenterology Research
Mentor, Ohio, 44060
Lead Clinical Research Coordinator, 216-387-4966, susand@greatlakesgastro.net
Keith Friedenberg, M.D.
- Recruiting
Suburban Gastroenterology
Naperville, Illinois, 60540
Site Manager, 708-253-5810, devang.shah@avicennaclinical.com
Thomas Couri, M.D.
- Recruiting
Southwest Gastroenterology
Oak Lawn, Illinois, 60453
Site Manager, 708-253-5810, devang.shah@avicennaclinical.com
Kamran Ayub, M.D.
- Recruiting
Knowledge Research Center
Orange, California, 92868
Regulatory/Study Coordinator, 657-247-0087, j.bermudez@knowledgeresearchcenter.com
Alla Abousaif, M.D.
- Recruiting
Gastroenterology Group of Rochester
Rochester, New York, 14618
Lead Study Coordinator, 585-278-1116, bvasciannie@ggr1.com
Jonathan Wilmot, M.D.
- Recruiting
Advanced Research Institute
St. Petersburg, Florida, 33710
Study Coordinator, 727-835-3261, lauren.scott@ariclinical.com
Jatin Bidani, M.D.
About this study
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
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:
- prep for and swallow a study capsule and then
- prep for and undergo a colonoscopy either the following day or 3-6 weeks later
- Conditions
- Colonic Polyps
- Being tested
- Capsule swallow
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule swallowDevice
Participant will swallow the investigational device
| Study group | Role | What they receive |
|---|---|---|
| A new capsule design is being used from that of the first phase of the study. | Experimental | Not described Receives: Device: Capsule swallow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Percentage Agreement
- Positive Percent Agreement (PPA) of the study device 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 ≥ 6 mm, 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.
Measured: From capsule swallow to Colonoscopy - up to 6 weeks
Negative Percentage Agreement
- Negative percent agreement (NPA) of the study device with CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm.
Measured: From Capsule swallow to colonoscopy - Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start26 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capso Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suejin Kim Study PI, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089615
- Sponsor's protocol ID
- CLN-CVI-5794 2nd Generation
- Status last verified
- May 2026
- First submitted
- 16 Jul 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07089615
- Acronym / sponsor ID
- CLN-CVI-5794 2nd Generation
- Conditions
- Colonic Polyps
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Capso Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- prep for and swallow a study capsule and then
- prep for and undergo a colonoscopy either the following day or 3-6 weeks later
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A new capsule design is being used from that of the first phase of the study. | Experimental | Device: Capsule swallow |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsule swallowParticipant will swallow the investigational device | Device | A new capsule design is being used from that of the first phase of the study. |
Primary outcome
Positive Percentage Agreement
Time frame: From capsule swallow to Colonoscopy - up to 6 weeks
• Positive Percent Agreement (PPA) of the study device 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 ≥ 6 mm, 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.
Negative Percentage Agreement
Time frame: From Capsule swallow to colonoscopy - Up to 6 weeks
• Negative percent agreement (NPA) of the study device with CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Petersen Sr. Director of Clinical Affairs contact
Suejin Kim Study PI, M.D. principal investigator
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsule swallow in people with Colonic Polyps, run by Capso Vision, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Williamsen Principle CRA/Study Lead (815-861-9575, taylor.williamsen@capsovision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Percentage Agreement (time frame: From capsule swallow to Colonoscopy - up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.