COMPLETED

Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.

Official Title

Prospective Open Label, Pivotal Study of the Accuracy of The CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

Quick Facts

Study Start:2021-01-06

Study Completion:2025-02-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04607746

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 45-75 years of age 2. Committed to undergo a colonoscopy, independent of this study 3. Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor	1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps 2. Has contraindication for capsule endoscopy or colonoscopy 3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome 4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease 5. History of incomplete colonoscopy 6. 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.) 7. Impaired cardiac function assessed as greater than NYHA Class II 8. History of small- or large-bowel obstructive condition 9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis 10. 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 11. Known allergy to ingredients used in bowel preparation and boosters 12. Daily and/or regular narcotic use 13. Decompensated cirrhosis 14. Prior abdominal radiation therapy 15. Diagnosis of anorexia or bulimia 16. 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 17. Known or suspected megacolon 18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule 19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis 20. Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. WOCBP must have a negative urine pregnancy test at screening. 21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures 22. 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 23. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study 24. Chronic constipation as defined by \<3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements

Inclusion Criteria

Exclusion Criteria

1. At least 45-75 years of age
2. Committed to undergo a colonoscopy, independent of this study
3. Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor

1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
2. Has contraindication for capsule endoscopy or colonoscopy
3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
5. History of incomplete colonoscopy
6. 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.)
7. Impaired cardiac function assessed as greater than NYHA Class II
8. History of small- or large-bowel obstructive condition
9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
10. 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
11. Known allergy to ingredients used in bowel preparation and boosters
12. Daily and/or regular narcotic use
13. Decompensated cirrhosis
14. Prior abdominal radiation therapy
15. Diagnosis of anorexia or bulimia
16. 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
17. Known or suspected megacolon
18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
20. Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. WOCBP must have a negative urine pregnancy test at screening.
21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
22. 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
23. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
24. Chronic constipation as defined by \<3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements

Contacts and Locations

Principal Investigator

David Shields, MD

PRINCIPAL_INVESTIGATOR

Gastroenterology Consultant at San Mateo County Medical Center

Study Locations (Sites)

Mayo Clinic

Scottsdale, Arizona, 85259

United States

Gastro Care Institute

Lancaster, California, 93534

United States

inSite Digestive Health Care

Los Gatos, California, 95032

United States

Knowledge Research Center

Orange, California, 92868

United States

Kaiser Permanente Northern California

San Leandro, California, 94577

United States

Advanced Research Institute

New Port Richey, Florida, 34653

United States

Digestive and Liver Center of Florida

Orlando, Florida, 32825

United States

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684

United States

Advanced Research Institute

Saint Petersburg, Florida, 33710

United States

Digestive Health Services

Downers Grove, Illinois, 60515

United States

Northshore Center for Gastroenterology

Libertyville, Illinois, 60048

United States

Suburban Gastroenterology

Naperville, Illinois, 60540

United States

Southwest Gastroenterology

New Lenox, Illinois, 60451

United States

Digestive Health Specialists

Chelmsford, Massachusetts, 01824

United States

West Michigan Clinical Research Center

Wyoming, Michigan, 49519

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Hattiesburg GI Associates

Hattiesburg, Mississippi, 39402

United States

NY total Medical Care, PC

Brooklyn, New York, 11215

United States

Gastroenterology Group of Rochester

Rochester, New York, 14618

United States

Great Lakes Gastroenterology Research

Mentor, Ohio, 44060

United States

Tri-Cities Gastroenterology

Kingsport, Tennessee, 37663

United States

Vilo Research Group

Houston, Texas, 77017

United States

Gastroenterology Consultants of SW Virginia

Roanoke, Virginia, 24014

United States

Collaborators and Investigators

Sponsor: Capso Vision, Inc.

David Shields, MD, PRINCIPAL_INVESTIGATOR, Gastroenterology Consultant at San Mateo County Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-06

Study Completion Date2025-02-14

Study Record Updates

Study Start Date2021-01-06

Study Completion Date2025-02-14

Terms related to this study

Additional Relevant MeSH Terms

Colonic Polyp