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

NCT01820182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

  • Anemia
  • Gastrointestinal Bleedings
  • Méléna
  • Angiodysplasia
  • Polyps

Interventions

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

Sponsors & Collaborators

  • Capso Vision, Inc.

    collaborator INDUSTRY

  • Hôpital Edouard Herriot

    lead OTHER

Principal Investigators

  • Saurin JS Jean Christophe, Msd

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-06-30
Completion
2012-06-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01820182 on ClinicalTrials.gov