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

NCT ID: NCT02852161

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-10-31

Brief Summary

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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

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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.

Conditions

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Barrett's Oesophagus Oesophageal Varices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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MACE

MACE procedure

Group Type EXPERIMENTAL

Magnet assissted capsule endoscopy

Intervention Type DEVICE

Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day

OGD

Clinically indicated gastroscopy

Group Type ACTIVE_COMPARATOR

Magnet assissted capsule endoscopy

Intervention Type DEVICE

Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day

Interventions

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Magnet assissted capsule endoscopy

Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krish Ragunath

Role: STUDY_CHAIR

Nottingham University

Locations

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Nottingham University Hospital

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31678203 (View on PubMed)

Other Identifiers

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15109

Identifier Type: -

Identifier Source: org_study_id

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