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

Primary Purpose

Barrett's Oesophagus, Oesophageal Varices

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Magnet assissted capsule endoscopy
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Barrett's Oesophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nottingham University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MACE

OGD

Arm Description

MACE procedure

Clinically indicated gastroscopy

Outcomes

Primary Outcome Measures

Diagnostic accuarcy
endoscopic

Secondary Outcome Measures

comfort
questionnaire

Full Information

First Posted
July 28, 2016
Last Updated
January 6, 2022
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT02852161
Brief Title
The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study
Acronym
MACE
Official Title
The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy in detecting esophageal pathology compared to standard endoscopy.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Oesophagus, Oesophageal Varices

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MACE
Arm Type
Experimental
Arm Description
MACE procedure
Arm Title
OGD
Arm Type
Active Comparator
Arm Description
Clinically indicated gastroscopy
Intervention Type
Device
Intervention Name(s)
Magnet assissted capsule endoscopy
Intervention Description
Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day
Primary Outcome Measure Information:
Title
Diagnostic accuarcy
Description
endoscopic
Time Frame
immediate
Secondary Outcome Measure Information:
Title
comfort
Description
questionnaire
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krish Ragunath
Organizational Affiliation
Nottingham University
Official's Role
Study Chair
Facility Information:
Facility Name
Nottingham University Hospital
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31678203
Citation
Beg S, Card T, Warburton S, Rahman I, Wilkes E, White J, Ragunath K. Diagnosis of Barrett's esophagus and esophageal varices using a magnetically assisted capsule endoscopy system. Gastrointest Endosc. 2020 Apr;91(4):773-781.e1. doi: 10.1016/j.gie.2019.10.031. Epub 2019 Oct 31.
Results Reference
derived

Learn more about this trial

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

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