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

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.

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Key information

Conditions

Anemia Angiodysplasia Cardiovascular Diseases Gastrointestinal Bleedings Hematologic Diseases Hemic and Lymphatic Diseases Méléna Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

capsule endoscopies

Device

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

Other names: Pillcam SB2, Capsocam

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

Sponsors and collaborators

Lead sponsor

Hôpital Edouard Herriot

Other

Collaborators

Capso Vision, Inc.

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Mar 28, 2013
Registry last updated: Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed