Can Steerable Capsule Endoscopy Enhance Gastric Emptying?

March 20, 2015 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Randomised Comparison of a Standard Protocol Using Metoclopramide Versus a Hand Held Magnet to Enhance Gastric Emptying of the Small Bowel Capsule.

Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected diseases of the small bowel. The procedure is safe and noninvasive, the main risk being capsule retention occurring in approximately 2% of procedures. Other problems such as incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric emptying, slow small bowel transit, faulty equipment and poor bowel preparation.

Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime' viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an intramuscular prokinetic injection if this fails. This approach has disadvantages since an intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly used for this purpose, has a risk of acute dystonic reactions particularly in young patients.

Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the capsule in the upper GI tract. We propose that this could be used, alongside positional changes, to expedite capsule transit through the stomach thus improving completion rates and avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled study comparing a standard protocol for small bowel capsule endoscopy against a hand held magnet and positional change protocol to enhance gastric emptying of the wireless capsule.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 20 years or over
  • Patients attending hospital for small bowel endoscopy examination

Exclusion Criteria:

  • Patients under the age of 20 years
  • Patients with a permanent pacemaker, or implantable cardioverter-defibrillator
  • Patients with any electronic/magnetic/mechanically controlled devices
  • Patients that are pregnant
  • Patients who are unable to understand or speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wireless Capsule Endoscopy
Wireless capsule endoscopy is the investigation modality of choice for suspected diseases of the small bowel. A small pill-sized capsule contianing a camera is swallowed by the patient. The procedure is safe and non-invasive. Normally, the pill camera travels through the gut an exits the bowel via natural means. In a small number of cases the capsule is maintained. If the capsule is still in the stomach, mobilisation is encouraged followed by an intramuscular pro-kinetic injection if this fails.
Device: Wireless Capsule Endoscopy
Other Names:
  • Swallowable pill camera
Active Comparator: Magnetically steerable capsule endoscopy
A handheld magnet (manufactured by Intromedic Ltd.) has been developed to allow some control of the pill camera (that contains a small amount of magnetic material) in the upper GI tract. We propose that this could be used, alongside positional changes, to expedite capsule transit through the stomach thus improving completion rates and avoiding the risks of unnecessary medication.
Device: Magnetically steerable capsule endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion rate of small bowel endoscopy examination
Time Frame: Baseline
Baseline
Duration of time taken for camera capsule to enter duodenum.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • STH17268

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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