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Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy

NCT01085513 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2020-07-22

Study results available
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Summary

Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients, and requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world.

A novel method for evaluation of intestinal motility has been developed based on endoluminal image analysis using the endoscopic PillCam capsule, In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is fully automated by a computer program.

The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity.

This technique needs now to be validated in a large multinational population, to further develop a robust discrimination algorithm for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved.

This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.

Conditions

  • Intestinal Abnormalities

Interventions

DEVICE

PillCam SB2

The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Fernando Azpiroz, Prof. · Universitat Autonoma de Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-12-31
Completion
2013-06-30

Countries

  • United States
  • Belgium
  • Italy
  • Spain
  • Sweden

Study Locations

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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 NCT01085513 on ClinicalTrials.gov