NCT02852161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 10, 2022

Status Verified

January 1, 2022

Enrollment Period

2.3 years

First QC Date

July 28, 2016

Last Update Submit

January 6, 2022

Conditions

Barrett's OesophagusOesophageal Varices

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuarcy

    endoscopic

    immediate

Secondary Outcomes (1)

  • comfort

    2 weeks

Study Arms (2)

MACE

EXPERIMENTAL

MACE procedure

Device: Magnet assissted capsule endoscopy

OGD

ACTIVE COMPARATOR

Clinically indicated gastroscopy

Device: Magnet assissted capsule endoscopy

Interventions

Magnet assissted capsule endoscopyDEVICE

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

MACEOGD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to give consent Pregnant Pacemaker swallowing difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospital

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31678203DERIVED

MeSH Terms

Conditions

Barrett EsophagusEsophageal and Gastric Varices

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Krish Ragunath

    Nottingham University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 2, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

January 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)