Colon Capsule for Colonic Polyps

Recruiting at 3 trial locations

Overseen By Rebecca Petersen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Capso Vision, Inc.

Must be taking: Pro-kinetic

Must not be taking: Narcotics, NSAIDs

Disqualifiers: Diabetes, Cardiac issues, Bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you use narcotics regularly or have a history of NSAID-related issues, you may not be eligible to participate.

What data supports the effectiveness of the treatment CV-3E AI Software for detecting colonic polyps?

Research shows that artificial intelligence, particularly using deep learning methods like convolutional neural networks, can effectively detect polyps in colon capsule endoscopy images with a sensitivity of up to 98.1%. This suggests that AI software like CV-3E could be highly effective in identifying colonic polyps. ^{1 2 3 4 5}

Is the Colon Capsule for Colonic Polyps safe for humans?

The Colon Capsule, used for viewing the colon, is considered safe and minimally invasive, with no major adverse events reported in studies. It does not require sedation and is generally well-tolerated by patients. ^{1 6 7 8 9}

How does the Colon Capsule treatment for colonic polyps differ from other treatments?

The Colon Capsule treatment is unique because it is a minimally invasive procedure that uses a small camera capsule to capture images of the colon, unlike traditional colonoscopy which requires inserting a tube. This method, combined with artificial intelligence, enhances polyp detection and reduces the time needed for experts to review the images. ^{1 3 10 11 12}

Eligibility Criteria

This clinical trial is for healthy volunteers who need a colonoscopy. Participants will follow specific preparation and dietary guidelines, swallow a capsule (CapsoCam® Colon CV-3E), ensure its passage through the digestive system, retrieve it, and return it to the sponsor.

Inclusion Criteria

I am between 45 and 75 years old.

I have agreed to join the study and signed the consent form.

Exclusion Criteria

Scheduled to undergo MRI examination within 7 days after ingestion of the capsule

Unable to follow or tolerate fasting, bowel preparation, and other study procedures

Currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants adhere to bowel prep, ingest pro-kinetic medication and CapsoCam® Colon (CV-3E), and follow dietary requirements until capsule passes

1 week

1 visit (in-person)

Follow-up

Participants retrieve capsule and mail it back, followed by a follow-up phone call

1 week

1 call (virtual)

Treatment Details

Interventions

• CV-3E AI Software

Trial Overview The trial aims to collect images from a swallowed capsule device in order to develop computer-aided detection software. There's no analysis during this study; it's purely for data collection purposes as participants go about the process.

Participant Groups

Group I: All Participants Experimental Treatment 1 Intervention

All participants will swallow the CapsoCam® Colon (CV-3E).

Who Is Running the Clinical Trial?

Capso Vision, Inc.

Lead Sponsor

Trials

6

Recruited

1,800+

Findings from Research

Colon capsule endoscopy (CCE) shows high diagnostic accuracy for detecting colorectal polyps, with sensitivities of 87% for polyps ≥6 mm and ≥10 mm, and specificities of 87% and 95%, respectively, based on a systematic review of 13 studies.

Despite its effectiveness, patient preference for CCE over traditional optical colonoscopy remains unclear, indicating a need for further research to improve acceptance and adherence to CCE as a screening method for colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials. Möllers, T., Schwab, M., Gildein, L., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Artificial Intelligence in Colon Capsule Endoscopy-A Systematic Review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Current status and limitations of artificial intelligence in colonoscopy. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Automatic detection of colorectal neoplasia in wireless colon capsule endoscopic images using a deep convolutional neural network. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Automatic textual description of colorectal polyp features: explainable artificial intelligence. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Benefits and challenges in implementation of artificial intelligence in colonoscopy: World Endoscopy Organization position statement. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The colon - the latest terrain for capsule endoscopy. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Addressing priority challenges in the detection and assessment of colorectal polyps from capsule endoscopy and colonoscopy in colorectal cancer screening using machine learning. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Second-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Accuracy of capsule colonoscopy and computed tomographic colonography in individuals with positive results from the fecal occult blood test. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Comprehensive review of publicly available colonoscopic imaging databases for artificial intelligence research: availability, accessibility, and usability. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Artificial intelligence to improve polyp detection and screening time in colon capsule endoscopy. [2022]