Colon Capsule for Colonic Polyps

No longer recruiting at 3 trial locations
KJ
RP
Overseen ByRebecca Petersen
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Capso Vision, Inc.
Must be taking: Pro-kinetic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on developing software to detect colonic polyps using capsule images from the CapsoCam® Colon device. The goal is to enhance image analysis for future colonoscopy procedures. Participants must follow specific dietary guidelines, take medication to aid the capsule's movement through the digestive system, and return the capsule after it passes. This trial suits individuals referred for a colonoscopy who have not recently undergone a procedure showing no polyps. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve future colonoscopy experiences.

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 prior data suggests that the CapsoCam® Colon (CV-3E) is safe for use in healthy volunteers?

Research shows that the CapsoCam® Colon (CV-3E) is generally easy for patients to handle. Patients swallow this tiny camera capsule to capture images of the colon, aiding doctors in identifying polyps. In past uses of similar technology, most people did not experience significant side effects. Some might feel mild discomfort, such as bloating or cramping, but these effects usually resolve quickly.

This trial is in the "Not Applicable" phase, focusing on gathering data to develop AI software with the CapsoCam® Colon. This phase indicates that safety is not the primary concern, likely because previous studies have already demonstrated the technology's safety. Although this trial does not include a specific safety analysis, earlier studies have not reported major safety issues with similar capsule cameras.12345

Why are researchers excited about this trial?

Researchers are excited about the CV-3E AI Software because it introduces a new way to detect colonic polyps using the CapsoCam® Colon capsule. Unlike traditional colonoscopies, which are invasive and require sedation, this method involves swallowing a small capsule equipped with a camera, making the process less uncomfortable and more accessible. The AI software assists in analyzing the images captured by the capsule, potentially increasing the accuracy and efficiency of polyp detection. This innovative approach could lead to earlier detection and treatment of colonic polyps, improving outcomes for patients.

What evidence suggests that this device is effective for detecting colonic polyps?

Studies have shown that artificial intelligence (AI) technology, such as the CV-3E AI software, effectively identifies growths in the colon called polyps. Research indicates that AI use during colonoscopies helps doctors more easily detect adenomas, polyps that might become cancerous. In this trial, participants will swallow the CapsoCam® Colon (CV-3E), which captures images of the colon. The AI analyzes these images to spot polyps with greater accuracy. Early findings suggest this method could be more reliable than regular screenings alone. Although still in development, initial results demonstrate its potential to improve early detection of colon issues.12356

Are You a Good Fit for This Trial?

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
See 22 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Capso Vision, Inc.

Lead Sponsor

Trials
6
Recruited
1,800+

Published Research Related to This Trial

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.
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]

Citations

Data Collection for CV-3E AI Software DevelopmentThe 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 ...
Colon Capsule for Colonic Polyps · Info for ParticipantsThis suggests that AI software like CV-3E could be highly effective in identifying colonic polyps. Show more ...
Effectiveness of artificial intelligence-assisted colonoscopy ...The results showed that different adjuvant interventions had significant differences in the detection rate of adenoma compared with routine ...
Data Collection for CV-3E AI Software DevelopmentThe goal of this clinical trial is to collect capsule images for the development of CADe software for use with the CapsoCam® Colon (CV-3E) ...
Data Collection for CV-3E AI Software Development | MedPathThe 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 ...
Colon Cancer Clinical TrialsThe purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps. It is ...
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