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NCT01820182 Clinical Trial

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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01820182
Other study ID # 2010-023341-29
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date June 2012

Study information
Verified date September 2023
Source Hôpital Edouard Herriot
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• capsule endoscopies
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

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Hôpital Edouard Herriot Capso Vision, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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