Status:
COMPLETED
Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule
Lead Sponsor:
Hôpital Edouard Herriot
Collaborating Sponsors:
Capso Vision, Inc.
Conditions:
Anemia
Gastrointestinal Bleedings
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the...
Detailed Description
Objectives Main objective To compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k\>0,6 Secondary objectives To compare the sensitivity and...
Eligibility Criteria
Inclusion
- over 18 years old
- obscure digestive bleeding justifying capsule endoscopy
- complete endoscopic work up including colonoscopy with ileoscopy and gastroscopy with aneathesia or sedation
- absence of concomittent ongoing study
- absence of occlusive symptoms of suspected Crohn's disease nor of previous small bowel radiotherapy
- filled inform consent
- no implanted pace maker
- patient being affiliated to the CPAM
Exclusion
- under 18 years old
- oral iron within 8 days before capsule endoscopy
- gastroparesis
- pacemaker
- swallowing troubles
- presence of oclusive symptoms suspected Crohn's disease nor of previous small bowel radiotherapy
- pregnancy or risk of pregnancy without efficient oral contraception
- absence of written informed consent
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01820182
Start Date
January 1 2011
End Date
June 1 2012
Last Update
September 21 2023
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