Colonic PolypsNCT06916845
Data Collection for CV-3E AI Software Development
A study testing Colon Capsule in people with Colonic Polyps, run by Capso Vision, Inc. at 4 sites in United States.
Trial summary
The goal of this clinical trial is to collect capsule images for the development of CADe software for use with the CapsoCam® Colon (CV-3E) in healthy volunteers who have been referred for colonoscopy. There will be no analysis performed as part of this protocol. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Colon Capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Mar 2025to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 45-75 years of age
- Choose to participate and must have signed the IRB-approved informed consent document.
Who cannot join
- Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
- Colonoscopy within the past 4 years that demonstrated polyps that were removed.
- Has contraindication for capsule endoscopy
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Digestive Diseases Center of Hattiesburg, LLC
Hattiesburg, Mississippi, 39402
Advanced Research Institute Inc
New Port Richey, Florida, 34653
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, 34684
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, 24014
About this study
Official title: Data Collection for CapsoView AI Software Development for the CapsoCam® Colon (CV-3E)
The goal of this clinical trial is to collect capsule images for the development of CADe software for use with the CapsoCam® Colon (CV-3E) in healthy volunteers who have been referred for colonoscopy. There will be no analysis performed as part of this protocol.
Participants will
- adhere to bowel prep instructions and dietary requirements
- ingest pro-kinetic medication and CapsoCam® Colon (CV-3E)
- adhere to booster regimen and dietary requirements until capsule passes
- retrieve capsule with retrieval kit per instructions and mail back to sponsor
- participate in follow-up phone call
- Conditions
- Colonic Polyps
- Being tested
- Colon Capsule
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon CapsuleDevice
All participants will swallow the CapsoCam® Colon (CV-3E) for this study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | All participants will swallow the CapsoCam® Colon (CV-3E). Receives: Device: Colon Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Capsule Images
No assessment will be done for this protocol. Videos will be collected for AI development for use in future study.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start16 Mar 2025
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capso Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916845
- Sponsor's protocol ID
- CLN-CVI-7472
- Status last verified
- Jul 2025
- First submitted
- 17 Mar 2025
- Last updated
- 3 Jul 2025
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for CapsoView AI Software Development for the CapsoCam® Colon (CV-3E)
- ClinicalTrials.gov ID
- NCT06916845
- Acronym / sponsor ID
- CLN-CVI-7472
- Conditions
- Colonic Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Capso Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2025 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 8 Apr 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.
The goal of this clinical trial is to collect capsule images for the development of CADe software for use with the CapsoCam® Colon (CV-3E) in healthy volunteers who have been referred for colonoscopy. There will be no analysis performed as part of this protocol.
Participants will
- adhere to bowel prep instructions and dietary requirements
- ingest pro-kinetic medication and CapsoCam® Colon (CV-3E)
- adhere to booster regimen and dietary requirements until capsule passes
- retrieve capsule with retrieval kit per instructions and mail back to sponsor
- participate in follow-up phone call
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Device: Colon CapsuleAll participants will swallow the CapsoCam® Colon (CV-3E). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 45-75 years of age
- Choose to participate and must have signed the IRB-approved informed consent document.
Key exclusion criteria (25 listed)
- Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
- Colonoscopy within the past 4 years that demonstrated polyps that were removed.
- Has contraindication for capsule endoscopy
- 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
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 |
|---|---|---|
| Colon CapsuleAll participants will swallow the CapsoCam® Colon (CV-3E) for this study. | Device | All Participants |
Primary outcome
Collect Capsule Images
Time frame: 4-6 months
No assessment will be done for this protocol. Videos will be collected for AI development for use in future study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colon Capsule in people with Colonic Polyps, run by Capso Vision, Inc. at 4 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 2 inclusion and 25 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: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect Capsule Images (time frame: 4-6 months). 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 3 Jul 2025.