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

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

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

Study Overview

• Status: Recruiting
• Conditions: Colonic Polyp
• Intervention / Treatment: Device: Capsule Endoscope

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Petersen; Phone Number: 510-566-8824; Email: rebecca.petersen@capsovision.com

Study Locations

• United States
  • California
    • Lancaster, California, United States, 93534
      • Recruiting
      • Gastro Care Institute
      • Contact: Ruben Varguas; Phone Number: 661-520-9944; Email: Rvargas@gciav.com
      • Principal Investigator: Kamaravel Perumalsamy, MD
    • San Leandro, California, United States, 94577
      • Recruiting
      • Kaiser Permanente Northern California
      • Contact: Jacquelene Catap; Phone Number: 619-316-3821
      • Principal Investigator: Sanja Garuda, MD
  • Florida
    • New Port Richey, Florida, United States, 34653
      • Recruiting
      • Advanced Research Institute
      • Contact: Lauren Scott; Phone Number: 727-835-3261; Email: lauren.scott@ariclinical.com
      • Principal Investigator: Curtis Freedland, DO
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • Recruiting
      • Digestive Health Services
      • Contact: Fatema Nomani; Email: fatema.nomani@avicennaclinical.com
      • Contact: Rashida Boxwalla; Phone Number: 708 212 1947; Email: munira@avicennaclinical.com
      • Principal Investigator: Rockford Yapp, MD
    • New Lenox, Illinois, United States, 60451
      • Recruiting
      • Southwest Gastroenterology
      • Principal Investigator: Kamran Ayub, MD
      • Contact: Katherine "Kiki" Sawertailo, PA-C; Phone Number: 630-276-3119; Email: ksawertailo@giparthersofil.com
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Recruiting
      • West Michigan Clinical Research Center
      • Contact: Rochelle Copeland; Phone Number: 616-608-8730; Email: rcopeland@gastro-assoc-wm.com
      • Principal Investigator: Allan Coates, DO
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Elizabeth Rajan, MD
      • Contact: Haley Thie; Email: Thie.Haley@mayo.edu
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • Recruiting
      • Hattiesburg GI Associates
      • Contact: Clay Foley; Phone Number: 601-268-5185; Email: cfoley@hgia.net
      • Principal Investigator: Stephen Buckley, MD
  • New York
    • Rochester, New York, United States, 14618
      • Recruiting
      • Gastroenterology Group of Rochester
      • Contact: Brielle Visciannie; Phone Number: 585-278-1116; Email: bvasciannie@ggr1.com
      • Principal Investigator: Jonathan Wilmont, MD
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Recruiting
      • Great Lakes Gastroenterology Research
      • Contact: Sue Davies; Phone Number: 440-205-1125; Email: susand@greatlakesgastro.net
      • Principal Investigator: Keith Friedenberg, MD
  • Tennessee
    • Kingsport, Tennessee, United States, 37633
      • Recruiting
      • Tri-Cities Gastroenterology
      • Contact: Maggie Powers; Email: mpowers@digestivewellness.net
      • Principal Investigator: Stephen Fry, MD
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Gastroenterology Consultants of SW Virginia
      • Principal Investigator: Nirish Shah, MD
      • Sub-Investigator: Vishal Bhagat, MD
      • Contact: Jody Caretti, MSc; Phone Number: 540-510-3330; Email: jcaretti@roanokegastro.onmicrosoft.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsule; 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.	Device: Capsule Endoscope; Capsule endoscope used to view colonic mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Capso Vision, Inc.
• Investigators: Principal Investigator: David Shields, MD, Private Practice

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: CLN-CVI-5794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No