330 Participants Needed

Capsule Swallow for Colonic Polyps

Recruiting at 10 trial locations
TW
RP
Overseen ByRebecca Petersen Sr. Director of Clinical Affairs
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 tests a new capsule camera, CapsoCam® Colon (CV-3), to evaluate its effectiveness in detecting polyps in the colon. The study also aims to determine if AI can enhance the accuracy and efficiency of video readings from these capsules. Participants will swallow the capsule and later undergo a traditional colonoscopy for comparison. Ideal candidates are those committed to a future colonoscopy and have not had any polyp-free colon tests in the past five years. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve future colonoscopy procedures.

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 regularly use narcotics or NSAIDs (non-steroidal anti-inflammatory drugs), you may not be eligible to participate. It's best to discuss your specific medications with the trial team.

What prior data suggests that the CapsoCam® Colon (CV-3) endoscope system is safe for detecting colonic polyps?

Research has shown that the CapsoCam® Colon (CV-3) is being tested for its safety and effectiveness in detecting colon polyps. Studies suggest that this capsule, swallowed like a pill, is generally easy for people to handle. Trials reviewed have reported no major harmful side effects.

While further testing continues, the capsule is designed to be comfortable and less invasive than traditional methods. Participants typically manage the capsule well, and research has noted no significant safety concerns. This suggests that the CapsoCam® Colon (CV-3) could be a safe option for those considering joining the clinical trial.12345

Why are researchers excited about this trial?

Unlike the standard of care for detecting colonic polyps, which typically involves a colonoscopy, the CapsoCam® Colon (CV-3) system offers a non-invasive alternative. This treatment is unique because it uses a swallowable capsule endoscope that captures images as it travels through the digestive tract. Researchers are excited about this innovation because it could make screening for colonic polyps more comfortable and accessible, especially for individuals who are hesitant about traditional colonoscopy procedures. Additionally, the capsule’s design improvements from earlier studies might enhance imaging capabilities, potentially leading to better polyp detection rates.

What evidence suggests that the CapsoCam® Colon (CV-3) endoscope system is effective for detecting colonic polyps?

Research shows that the CapsoCam® Colon (CV-3) capsule, used by participants in this trial, effectively detects colon polyps, which can indicate colon cancer. Studies have found that this capsule accurately identifies these polyps. AI technology enhances the accuracy and speed of polyp detection in video images. The capsule's results are compared to traditional colonoscopy, the current standard method. Early results are promising, suggesting that the capsule could serve as a reliable alternative for detecting polyps.12367

Who Is on the Research Team?

SK

Suejin Kim Study PI, M.D.

Principal Investigator

Are You a Good Fit for This Trial?

This clinical trial is for adults aged 45-75 who are planning to have a colonoscopy. It's designed to test the CapsoCam® Colon (CV-3) endoscope system, which involves swallowing a capsule that examines the colon for polyps.

Inclusion Criteria

I am willing to have a colonoscopy.
I am between 45 and 75 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Capsule Ingestion

Participants prep for and swallow a study capsule

1 day
1 visit (in-person)

Colonoscopy

Participants prep for and undergo a colonoscopy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CapsoCam® Colon (CV-3) endoscope system
Trial Overview The study compares the effectiveness of a new capsule endoscope system against traditional colonoscopy in detecting colonic polyps. Participants will swallow a second-generation capsule with AI-based technology and later undergo a standard colonoscopy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: A new capsule design is being used from that of the first phase of the study.Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Capso Vision, Inc.

Lead Sponsor

Trials
6
Recruited
1,800+

Citations

Pivotal Study of the CapsoCam Colon (CV-3) in Detecting ...This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps. Detailed Description.
A Study to Evaluate the Accuracy of the CapsoCam® ...The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic ...
Study Details | NCT07089615 | Prospective, Open-label, ...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 ...
Oncology (Medical) - 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 ...
Colon Capsule for Colonic Polyps · Info for ParticipantsWhat data supports the effectiveness of the treatment CV-3E AI Software for detecting colonic polyps? Research shows that artificial intelligence ...
Oncology (Medical) - 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 ...
Capsule Swallow for Colonic PolypsThis N/A medical study run by Capso Vision, Inc. is evaluating whether CapsoCam® Colon (CV-3) endoscope system will have tolerable side effects & efficacy ...
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