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

Colonic Polyp Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04607746
• Other study ID #: CLN-CVI-5794
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Capso Vision, Inc.
• Contact: Rebecca Petersen
• Phone: 510-566-8824
• Email: rebecca.petersen[@]capsovision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Device:
• Capsule Endoscope
Capsule endoscope used to view colonic mucosa

Locations

Country	Name	City	State
United States	Digestive Health Services	Downers Grove	Illinois
United States	Hattiesburg GI Associates	Hattiesburg	Mississippi
United States	Tri-Cities Gastroenterology	Kingsport	Tennessee
United States	Gastro Care Institute	Lancaster	California
United States	Great Lakes Gastroenterology Research	Mentor	Ohio
United States	Southwest Gastroenterology	New Lenox	Illinois
United States	Advanced Research Institute	New Port Richey	Florida
United States	Gastroenterology Consultants of SW Virginia	Roanoke	Virginia
United States	Gastroenterology Group of Rochester	Rochester	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Kaiser Permanente Northern California	San Leandro	California
United States	West Michigan Clinical Research Center	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Capso Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Percent Agreement/Negative Percent Agreement	Positive Percent Agreement (PPA) of CapsoCam® Colon (CV-3) for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is = 6 mm Negative Percent Agreement (NPA) of the device for not detecting any polyp = 6 mm in a subject for whom OC did not detect any polyp = 6 mm.	6 weeks
Secondary	Positive Percent Agreement/Negative Percent Agreement--secondary	PPA of the device for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is, = 6 mm and < 10 mm, or = 10 mm (same matching rules) NPA of the device for not detecting any polyp = 10 mm in a subject for whom OC did not detect any polyp = 6 mm and < 10 mm or = 10 mm.; PPA of the device for detecting the presence of a polyp = 6 mm in a subject with OC as the reference (without regard to polyp matching).; PPA of the device for detecting the presence in a subject of a polyp = 6 mm and < 10 mm with OC as the reference (without regard to polyp matching).; PPA of the device for detecting the presence in a subject of the largest sessile serrated polyp detected by OC if that polyp is = 6 mm, (same matching rules) PPA of the device for detecting the presence in a subject of a cancerous polyp biopsied by OC and diagnosed by histopathology, (same matching rules as above)	6 weeks