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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02852161
Other study ID # 15109
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date October 2018

Study information

Verified date January 2022
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United Kingdom Nottingham University Hospital Nottingham

Sponsors (1)

Lead Sponsor Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuarcy endoscopic immediate
Secondary comfort questionnaire 2 weeks
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