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Capsule Endoscope

Capsule Endoscopy for Detecting Polyps

N/A
Recruiting
Led By David Shields, MD
Research Sponsored by Capso Vision, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 45-75 years of age
Committed to undergo a colonoscopy, independent of this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will test a new camera to see if it's effective and safe for detecting colon polyps.

Who is the study for?
This trial is for adults aged 45-75 who plan to have a colonoscopy. They must consent to share their results and not have diabetes, severe heart issues, cirrhosis, or past abdominal radiation. Excluded are those with certain bowel diseases, recent other trials participation, pregnancy, swallowing disorders or regular narcotic use.Check my eligibility
What is being tested?
The CapsoCam Colon (CV-3) capsule endoscope's ability to detect colonic polyps is being tested against the standard colonoscopy procedure. Participants will swallow this camera pill that takes pictures of their colon as it passes through.See study design
What are the potential side effects?
Potential side effects may include discomfort from fasting and bowel preparation required for the procedure. There might also be risks associated with swallowing the capsule such as obstruction if there's an unknown stricture or blockage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 45 and 75 years old.
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I am willing to have a colonoscopy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive Percent Agreement/Negative Percent Agreement
Secondary outcome measures
Positive Percent Agreement/Negative Percent Agreement--secondary

Trial Design

1Treatment groups
Experimental Treatment
Group I: CapsuleExperimental Treatment1 Intervention
Participants will swallow the capsule for imaging prior to completing colonoscopy. Capsule swallow may be 1 day prior or 3-6 weeks prior to colonoscopy.

Find a Location

Who is running the clinical trial?

Capso Vision, Inc.Lead Sponsor
5 Previous Clinical Trials
590 Total Patients Enrolled
David Shields, MDPrincipal InvestigatorPrivate Practice
1 Previous Clinical Trials
84 Total Patients Enrolled

Media Library

CapsoCam Colon (CV-3) (Capsule Endoscope) Clinical Trial Eligibility Overview. Trial Name: NCT04607746 — N/A
Colorectal Adenomas Research Study Groups: Capsule
Colorectal Adenomas Clinical Trial 2023: CapsoCam Colon (CV-3) Highlights & Side Effects. Trial Name: NCT04607746 — N/A
CapsoCam Colon (CV-3) (Capsule Endoscope) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04607746 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for participants in this research project?

"The latest information from clinicaltrials.gov indicates that this investigation is actively seeking volunteers, with the original post date of January 6th 2021 and most recent edit on November 8th 2022."

Answered by AI

Do individuals aged 55 and older meet the requirements to be admitted into this trial?

"As outlined by the study's eligibility criteria, participants must fall between 45 and 75 years of age. Separately, there are 4 clinical studies for minors and 80 trials that cater to seniors over 65."

Answered by AI

How many individuals are being monitored for this clinical investigation?

"To meet the desired quota, 1500 eligible patients will need to enroll in this trial from locations like Hattiesburg GI Associates (Hattiesburg, Mississippi) and Gastroenterology Consultants of SW Virginia (Roanoke, Virginia)."

Answered by AI

At how many sites is this experiment administered?

"The trial is currently accepting patients at Hattiesburg GI Associates in Mississippi, Gastroenterology Consultants of SW Virginia in Roanoke, and Southwest Gastroenterology in New Lenox. Additionally, there are 8 other sites that prospective participants can attend."

Answered by AI

Is enrolment in this trial still open for participants?

"The target demographic for this clinical trial are individuals with polyps aged between 45 and 75, of whom around 1500 will be accepted."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
2021. "Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04607746.
~30 spots leftby Jun 2024
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