The trial is taking place at:
W

West Michigan Clinical Research Center | Wyoming, MI

Veeva-enabled site

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

C

Capso Vision

Status

Enrolling

Conditions

Colonic Polyp

Treatments

Device: Capsule Endoscope

Study type

Interventional

Funder types

Industry

Identifiers

NCT04607746
CLN-CVI-5794

Details and patient eligibility

About

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

Enrollment

1,200 estimated patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,200 participants in 1 patient group

Capsule
Experimental group
Description:
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.
Treatment:
Device: Capsule Endoscope

Trial contacts and locations

12

Loading...

Central trial contact

Rebecca Petersen

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems