Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852161
Recruitment Status : Unknown
Verified August 2017 by University of Nottingham.
Recruitment status was:  Recruiting
First Posted : August 2, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Barrett's Oesophagus Oesophageal Varices Device: Magnet assissted capsule endoscopy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study
Study Start Date : July 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. Diagnostic accuarcy [ Time Frame: immediate ]
    endoscopic


Secondary Outcome Measures :
  1. comfort [ Time Frame: 2 weeks ]
    questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852161


Contacts
Layout table for location contacts
Contact: Sabina Beg, MBBS, Bsc sabina.beg@nhs.net
Contact: Krish Ragunath k.ragunath@nottingham.ac.uk

Locations
Layout table for location information
United Kingdom
Nottingham University Hospital Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: SABINA BEG, MMS, BSC       SABINA.BEG@NHS.NET   
Contact: KRISH RAGUNATH       K.RAGUNATH@NOTTINGHAM.AC.UK   
Sponsors and Collaborators
University of Nottingham
Investigators
Layout table for investigator information
Study Chair: Krish Ragunath Nottingham University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02852161    
Other Study ID Numbers: 15109
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases