Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule in Patients With Obscure Digestive Bleedings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hôpital Edouard Herriot
- Enrollment
- 73
- Primary Endpoint
- number of discordant films between the two capsules with two different readers
Study Overview
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 Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated.
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 specificity of both capsule readings To copmpare the sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To check the tecnical fiability (incidence of technical issues To check the feasibility To evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
capsocam capsula
capsocam capsula readings
Intervention: capsule endoscopies (Device)
Outcomes
Primary Outcomes
number of discordant films between the two capsules with two different readers
Time Frame: 14 days
Reading of the two capsules film is randomized order by two different readers in each center
Secondary Outcomes
No secondary outcomes reported
Investigators
Jean Christophe Saurin
Proffessor
Hôpital Edouard Herriot