Phase
Condition
Polyps
Colon Polyps
Treatment
Capsule Endoscope
Clinical Study ID
Ages 45-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 consentdocument and agreed to release colonoscopy images and results report to Sponsor
Exclusion
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, hereditarynon polyposis colon cancer, or any high-risk genetic syndrome
Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerativecolitis or Crohn's disease
History of incomplete colonoscopy
Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C>6.4 within thepast 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 neuropathiesand/or radiation enteritis
Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on aregular basis that, in the opinion of the Investigator, would put the subject atgreater 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 intestinalobstruction, or internal hernias or abdominal surgeries that the Investigatorbelieves 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 medicallyacceptable methods of contraception. WOCBP must have a negative urine pregnancy testat screening.
Unable to follow or tolerate fasting, bowel preparation, and other study procedures
Any documented medical or psychological condition or significant concurrent illnesswhich, in the Investigator's opinion, would make it unsafe for the subject toparticipate in this research study or would affect the validity of the study results
Are currently enrolled in an interventional clinical study or currently enrolled inor within the last 30 days, a pharmaceutical clinical study
Chronic constipation as defined by <3 bowel movements per week, or the use ofroutine laxatives (other than fiber) to attain regular bowel movements
Study Design
Connect with a study center
Mayo Clinic
Scottsdale, Arizona 85259
United StatesSite Not Available
Gastro Care Institute
Lancaster, California 93534
United StatesActive - Recruiting
InSite Digestive Health Care
San Jose, California 95116
United StatesSite Not Available
Kaiser Permanente Northern California
San Leandro, California 94577
United StatesActive - Recruiting
Advanced Research Institute
New Port Richey, Florida 34653
United StatesActive - Recruiting
Digestive Health Services
Downers Grove, Illinois 60515
United StatesActive - Recruiting
Northshore Center for Gastroenterology
Libertyville, Illinois 60048
United StatesActive - Recruiting
Suburban Gastroenterology
Naperville, Illinois 60540
United StatesActive - Recruiting
Southwest Gastroenterology
New Lenox, Illinois 60451
United StatesActive - Recruiting
Digestive Health Specialists
Chelmsford, Massachusetts 01824
United StatesSite Not Available
West Michigan Clinical Research Center
Wyoming, Michigan 49519
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Hattiesburg GI Associates
Hattiesburg, Mississippi 39402
United StatesActive - Recruiting
NY Total Medical Care
Brooklyn, New York 11215
United StatesSite Not Available
Gastroenterology Group of Rochester
Rochester, New York 14618
United StatesActive - Recruiting
Great Lakes Gastroenterology Research
Mentor, Ohio 44060
United StatesActive - Recruiting
Tri-Cities Gastroenterology
Kingsport, Tennessee 37633
United StatesActive - Recruiting
Vilo Research
Houston, Texas 77017
United StatesSite Not Available
Gastroenterology Consultants of SW Virginia
Roanoke, Virginia 24014
United StatesActive - Recruiting
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