Phase
Condition
Polyps
Colon Polyps
Treatment
Colon Capsule
Clinical Study ID
Ages 45-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
45-75 years of age
Choose to participate and must have signed the IRB-approved informed consentdocument.
Exclusion
Exclusion Criteria:
Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
Colonoscopy within the past 4 years that demonstrated polyps that were removed.
Has contraindication for capsule endoscopy
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 of child-bearing potential and does not agree to practicemedically acceptable methods of contraception. Women of child bearing potential (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 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
Advanced Research Institute Inc
New Port Richey, Florida 34653
United StatesActive - Recruiting
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida 34684
United StatesActive - Recruiting
Digestive Diseases Center of Hattiesburg, LLC
Hattiesburg, Mississippi 39402
United StatesActive - Recruiting
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia 24014
United StatesActive - Recruiting
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