COMPLETED

Data Collection for CV-3E AI Software Development

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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

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

Official Title

Data Collection for CapsoView AI Software Development for the CapsoCam® Colon (CV-3E)

Quick Facts

Study Start:2025-03-16

Study Completion:2025-06-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06916845

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:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 45-75 years of age 2. Choose to participate and must have signed the IRB-approved informed consent document.	1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps 2. Colonoscopy within the past 4 years that demonstrated polyps that were removed. 3. Has contraindication for capsule endoscopy 4. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome 5. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease 6. History of incomplete colonoscopy 7. 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). 8. Impaired cardiac function assessed as greater than NYHA Class II 9. History of small- or large-bowel obstructive condition 10. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis 11. 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 12. Known allergy to ingredients used in bowel preparation and boosters 13. Daily and/or regular narcotic use 14. Decompensated cirrhosis 15. Prior abdominal radiation therapy 16. Diagnosis of anorexia or bulimia 17. 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 18. Known or suspected megacolon 19. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule 20. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis 21. Pregnant or nursing or of child-bearing potential and does not agree to practice medically acceptable methods of contraception. Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at screening. 22. Unable to follow or tolerate fasting, bowel preparation, and other study procedures 23. 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 24. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study 25. 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. 45-75 years of age
2. Choose to participate and must have signed the IRB-approved informed consent document.

1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
2. Colonoscopy within the past 4 years that demonstrated polyps that were removed.
3. Has contraindication for capsule endoscopy
4. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
5. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
6. History of incomplete colonoscopy
7. 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).
8. Impaired cardiac function assessed as greater than NYHA Class II
9. History of small- or large-bowel obstructive condition
10. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
11. 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
12. Known allergy to ingredients used in bowel preparation and boosters
13. Daily and/or regular narcotic use
14. Decompensated cirrhosis
15. Prior abdominal radiation therapy
16. Diagnosis of anorexia or bulimia
17. 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
18. Known or suspected megacolon
19. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
20. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
21. Pregnant or nursing or of child-bearing potential and does not agree to practice medically acceptable methods of contraception. Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at screening.
22. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
23. 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
24. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
25. 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

Study Locations (Sites)

Advanced Research Institute Inc

New Port Richey, Florida, 34653

United States

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684

United States

Digestive Diseases Center of Hattiesburg, LLC

Hattiesburg, Mississippi, 39402

United States

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia, 24014

United States

Collaborators and Investigators

Sponsor: Capso Vision, Inc.

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 Date2025-03-16

Study Completion Date2025-06-06

Study Record Updates

Study Start Date2025-03-16

Study Completion Date2025-06-06

Terms related to this study

Additional Relevant MeSH Terms

Colonic Polyps