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Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease

NCT03095573 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-03-30

No results posted yet for this study

Summary

Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration. The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small bowel through 360 degree lateral viewing. Celiac disease is the most common autoimmune enteropathy in Western countries, and is usually associated with a good response to the gluten free diet and an excellent prognosis. However, a minority of patients develop complications of the disease, such as refractory celiac disease, ulcerative jejunoileitis and neoplastic complications such as adenocarcinoma of the small bowel and enteropathy associated T cell lymphoma. In recent years, the detection of small bowel lesions has dramatically improved thank to the availability of capsule endoscopy exploration. The aim of this study was to evaluate detection rate and diagnostic concordance of the axial view capsule and CapsoCam capsules in the same patients.

Conditions

Interventions

DEVICE

Lateral-viewing CapsoCam device

Small bowel capsule endoscopy examination with the Lateral-viewing CapsoCam device

DEVICE

Axial-viewing capsule

Small bowel capsule endoscopy examination with the Axial-viewing capsule device

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    collaborator OTHER

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Luca Elli, MD, PhD · Fondazione IRCCS Ca´Granda Ospedale Maggiore Policlinico, Milano, Italy

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-10-31
Completion
2019-02-28
FDA Device
Yes

Countries

  • Italy

Study Locations

More Related Trials

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 NCT03095573 on ClinicalTrials.gov