The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study (MACE)

January 6, 2022 updated by: University of Nottingham
A pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy in detecting esophageal pathology compared to standard endoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a single centre feasibility study performed at Nottingham University Hospitals NHS Trusts.

We will assess the accuracy of MACE compared to gastroscopy in diagnosing Barretts oesophagus and esophageal varices. Patients will have both tests on the same ay, with the endoscopic findings compared.

Study Type

Interventional

Enrollment (Actual)

50

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
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Due to have a clinically indicated gastroscopy Barrett's oesophagus/ oesophageal varices or Controls Able to give informed consent

Exclusion Criteria:

Unable to give consent Pregnant Pacemaker swallowing difficulties

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MACE
MACE procedure
Device: Magnet assissted capsule endoscopy
Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day
ACTIVE_COMPARATOR: OGD
Clinically indicated gastroscopy
Device: Magnet assissted capsule endoscopy
Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuarcy
Time Frame: immediate
endoscopic
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comfort
Time Frame: 2 weeks
questionnaire
2 weeks

Collaborators and Investigators

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

Sponsor

University of Nottingham

Investigators

  • Study Chair: Krish Ragunath, Nottingham University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2016

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

October 1, 2018

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (ESTIMATE)

August 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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