Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule

Study Overview
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Brief Summary
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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
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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

Official Title
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Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule in Patients With Obscure Digestive Bleedings

Conditions
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Anemia, Gastrointestinal Bleedings, Méléna, Angiodysplasia, Polyps

Intervention / Treatment
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* Device: capsule endoscopies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: capsocam capsula<br>capsocam capsula readings | Device: capsule endoscopies<br>* Patients inclusion following inclusion criterias Randomization of capsule ingestion order Videocapsule recording by the two capsules Reading of the two capsules films in randomized order by two different readers in each center Reviewing of discordant capsule films by an expert panel<br>* Other names: Capsocam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of discordant films between the two capsules with two different readers | Reading of the two capsules film is randomized order by two different readers in each center | 14 days |