None listed
Conditions
Interventions
This is a prospective study aimed to validate the ability of capsule endoscopy to accurately diagnose small bowel Crohns disease in symptomatic patients who have a non-diagnostic standard workup. Patients will be randomized to undergo capsule endoscopy either one week or five weeks after enrolment. Patients will be followed up for up to 3 months after capsule endoscopy.
Sponsors
Given Imaging Ltd., New Industrial Park, Yoqneam, Israel
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient suffers from abdominal pain and/or diarrhea for the last 6 weeks and/or expresses extra-intestinal manifestations of CD. 2.Patient has at least one of the following over the preceding 6 months (plus symptoms suspicious of small bowel Crohns Disease): oPositive inflammatory marker (ESR, CRP, thrombocytosis, leucocytosis, fecal lactoferrin, fecal antitrypsin)ounexplained anemia,orecurrent fever,oweight loss (at least 10% of normal body weight in adults),ohypoalbuminaemia (<3.5 g/dL),ogastro-intestinal bleeding,ochronic perianal disease (fistula, fissure),oabnormal white cell scanopositive ASCAofirst degree relative of a person suffering from IBD (only for subjects without known IBD), 3.Patient underwent standard evaluation that includes colonoscopy and attempted ileoscopy and also SBFT within six months prior to enrollment, which were non-diagnostic. Blood tests should have been done within one month of enrolment. 4.Patient or legal guardian agrees to sign the Informed Consent Form
Exclusion criteria
1.Patients with indeterminate colitis where the purpose is only to make a definitive diagnosis and where the inclusion criteria are not otherwise met2.Patient is known to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting)3.Definite stricture seen on SBFT 4.Patient had suspected GI stricture, a Given® Patency capsule was administered and Patient did not pass the Patency capsule. 5.Patient has a pacemaker or other implanted electro-medical device6.Patient has known history of small bowel Crohns disease7.Patient on treatment for active IBD 8.Patient with suspected celiac disease that has not been excluded 9.Patient on non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or higher) during the 3 months preceding enrolment10.Patient is pregnant11.Patient has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems12.Patient suffers from life threatening conditions13.Patient is currently participating in another clinical study that may directly or indirectly affect the results of this study
Outcome results
None listed