CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)

NCT ID: NCT04246632

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-25
• Study Completion Date: 2021-03-15

Brief Summary

This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy.

Conditions

Colonoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Open label

Single arm study, all subjects receive device

Group Type: EXPERIMENTAL

CapsoCam Colon Capsule Endoscopy

Intervention Type: DEVICE

CapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults.

Interventions

CapsoCam Colon Capsule Endoscopy

CapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Between the ages of 50 and 75 years old

2. Subject meets at least one of the following criteria for increased risk for polyps:

1. Recent history (within 6 months) of positive FIT/iFOBT or Cologuard test

2. Older than 55 years of age, without prior history of colonoscopy

3. Has had a positive colonoscopy ≥ 5 years prior to screening visit

4. And/or having at least two of the following risk factors:

• Current smoker
• BMI of ≥30
• Family history (blood relative) of colorectal cancer
• Sedentary lifestyle
• Low fiber/ high fat diet

3. No contraindication for capsule endoscopy or colonoscopy

4. Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion

5. 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. History of negative colonoscopy within the last 10 years

2. History of incomplete colonoscopy

3. Impaired cardiac function assessed as greater than NYHA Class II

4. History of small- or large-bowel obstructive condition

5. Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease and/or radiation enteritis

6. 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 patient at greater risk for capsule endoscope retention

7. Unable to follow or tolerate fasting, bowel preparation, and other study procedures

8. Known allergy to ingredients used in bowel preparation and boosters

9. Daily and/or regular use of narcotics

10. Known or suspected AIDS

11. Uncompensated cirrhosis

12. Prior abdominal radiation therapy

13. Diagnosis of anorexia or bulimia

14. History of or suspicion for: strictures, volvulus or intestinal obstruction; internal hernias or abdominal surgeries that the Investigator considers as an exclusion

15. Known or suspected megacolon

16. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule

17. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis

18. Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening.

19. 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

20. Are currently enrolled in, or participated in within the last 30 days, another clinical study

21. Chronic constipation as defined by <3 bowel movements per week for at least 3 months prior to Screening, or the use of routine laxatives (other than fiber) to attain r regular bowel movements for at least 3 months prior to Screening

22. History of diabetes in which the prolonged fasting schedule could impose additional safety risks, as determined by the investigator

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capso Vision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Silicon Valley Research Institute, Inc.

San Jose, California, United States

CapsoVision Research Clinic

Saratoga, California, United States

West Michigan Clinical Research Center

Wyoming, Michigan, United States

Countries

United States

Other Identifiers

CLN-CVI-5248

Identifier Type: -

Identifier Source: org_study_id