- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04607746
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
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rebecca Petersen
- Phone Number: 510-566-8824
- Email: rebecca.petersen@capsovision.com
Study Locations
-
-
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
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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
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Principal Investigator:
- Keith Friedenberg, MD
-
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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
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
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
Time Frame: 6 weeks
|
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
Time Frame: 6 weeks
|
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
Investigators
- Principal Investigator: David Shields, MD, Private Practice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN-CVI-5794
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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