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

NCT ID: NCT01820182

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-06-30

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

Conditions

Anemia; Gastrointestinal Bleedings; Méléna; Angiodysplasia; Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

capsocam capsula

capsocam capsula readings

Group Type: EXPERIMENTAL

capsule endoscopies

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Pillcam SB2; Capsocam

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capso Vision, Inc.

INDUSTRY

Sponsor Role: collaborator

Hôpital Edouard Herriot

OTHER

Sponsor Role: lead

Responsible Party

Jean Christophe Saurin

Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saurin JS Jean Christophe, Msd

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2010-023341-29

Identifier Type: -

Identifier Source: org_study_id