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

Primary Purpose

Colonic Polyp

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Capsule Endoscope
Sponsored by
Capso Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyp

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kaiser Permanente Northern CaliforniaRecruiting
  • Advanced Research InstituteRecruiting
  • Southwest GastroenterologyRecruiting
  • West Michigan Clinical Research CenterRecruiting
  • Mayo ClinicRecruiting
  • Hattiesburg GI AssociatesRecruiting
  • Great Lakes Gastroenterology ResearchRecruiting
  • Tri-Cities GastroenterologyRecruiting
  • Gastroenterology Consultants of SW VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capsule

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
October 23, 2020
Last Updated
June 7, 2023
Sponsor
Capso Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04607746
Brief Title
Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Capso Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capsule
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Capsule Endoscope
Intervention Description
Capsule endoscope used to view colonic mucosa
Primary Outcome Measure Information:
Title
Positive Percent Agreement/Negative Percent Agreement
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Positive Percent Agreement/Negative Percent Agreement--secondary
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 45-75 years of age Committed to undergo a colonoscopy, independent of this study 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: Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps Has contraindication for capsule endoscopy or colonoscopy Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease History of incomplete colonoscopy 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.) Impaired cardiac function assessed as greater than NYHA Class II History of small- or large-bowel obstructive condition Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis 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 Known allergy to ingredients used in bowel preparation and boosters Daily and/or regular narcotic use Decompensated cirrhosis Prior abdominal radiation therapy Diagnosis of anorexia or bulimia 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 Known or suspected megacolon Scheduled to undergo MRI examination within 7 days after ingestion of the capsule Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis 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. Unable to follow or tolerate fasting, bowel preparation, and other study procedures 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 Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study Chronic constipation as defined by <3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Petersen
Phone
510-566-8824
Email
rebecca.petersen@capsovision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Shields, MD
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northern California
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacquelene Catap
Phone
619-316-3821
First Name & Middle Initial & Last Name & Degree
Sanja Garuda, MD
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Scott
Phone
727-835-3261
Email
lauren.scott@ariclinical.com
First Name & Middle Initial & Last Name & Degree
Curtis Freedland, DO
Facility Name
Southwest Gastroenterology
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Alles, PA-C
Phone
708-717-9110
Email
leahalles03@gmail.com
First Name & Middle Initial & Last Name & Degree
Kamran Ayub, MD
Facility Name
West Michigan Clinical Research Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochelle Copeland
Phone
616-608-8730
Email
rcopeland@gastro-assoc-wm.com
First Name & Middle Initial & Last Name & Degree
Allan Coates, DO
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Crystal Lavey
Email
lavey.crystal@mayo.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Rajan, MD
Facility Name
Hattiesburg GI Associates
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clay Foley
Phone
601-268-5185
Email
cfoley@hgia.net
First Name & Middle Initial & Last Name & Degree
Stephen Buckley, MD
Facility Name
Great Lakes Gastroenterology Research
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Davies
Phone
440-205-1125
Email
susand@greatlakesgastro.net
First Name & Middle Initial & Last Name & Degree
Keith Friedenberg, MD
Facility Name
Tri-Cities Gastroenterology
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37633
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Powers
Email
mpowers@digestivewellness.net
First Name & Middle Initial & Last Name & Degree
Stephen Fry, MD
Facility Name
Gastroenterology Consultants of SW Virginia
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darian Trojacek, MSc
Email
dtrojacek@roanokegastro.onmicrosoft.com
First Name & Middle Initial & Last Name & Degree
Nirish Shah, MD
First Name & Middle Initial & Last Name & Degree
Vishal Bhagat, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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