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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Polyps; Angiodysplasia; Gastrointestinal Bleedings; Méléna
• Intervention / Treatment: Device: capsule endoscopies

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: capsocam capsula; capsocam capsula readings	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; Other Names: Pillcam SB2; Capsocam

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hôpital Edouard Herriot
• Collaborators: Capso Vision, Inc.
• Investigators: Principal Investigator: Saurin JS Jean Christophe, Msd

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 21, 2013
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimated): March 28, 2013

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Angiodysplasia
• Other Study ID Numbers: 2010-023341-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes