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

Not Applicable

Completed

• Conditions: Angiodysplasia; Méléna; Gastrointestinal Bleedings; Polyps; Anemia
• Interventions: Device: capsule endoscopies

• Registration Number: NCT01820182
• Lead Sponsor: Hôpital Edouard Herriot

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
capsocam capsula	capsule endoscopies	capsocam capsula readings

Primary Outcome Measures

Name	Time	Method
number of discordant films between the two capsules with two different readers	14 days	Reading of the two capsules film is randomized order by two different readers in each center