Barrett's OesophagusMACENCT02852161
The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study
A study testing Magnet assissted capsule endoscopy in people with Barrett's Oesophagus and Oesophageal Varices, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Oesophagus, Oesophageal Varices
- What is being tested?
- Magnet assissted capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Due to have a clinically indicated gastroscopy Barrett's oesophagus/ oesophageal varices or Controls Able to give informed consent
Who cannot join
- Unable to give consent Pregnant Pacemaker swallowing difficulties
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospital
Nottingham, NG7 2UH
About this study
A pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy in detecting esophageal pathology compared to standard endoscopy.
Read the 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.
- Conditions
- Barrett's Oesophagus, Oesophageal Varices
- Being tested
- Magnet assissted capsule endoscopy
- Medical subject headings
- Barrett Esophagus, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnet assissted capsule endoscopyDevice
Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day
| Study group | Role | What they receive |
|---|---|---|
| MACE | Experimental | MACE procedure Receives: Device: Magnet assissted capsule endoscopy |
| OGD | Active comparator | Clinically indicated gastroscopy Receives: Device: Magnet assissted capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuarcy
endoscopic
Measured: immediate
Secondary outcomes (1)
comfort
questionnaire
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett's OesophagusStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krish Ragunath, Study chair, Nottingham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852161
- Sponsor's protocol ID
- 15109
- Acronym
- MACE
- Status last verified
- Jan 2022
- First submitted
- 28 Jul 2016
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31678203
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study
- ClinicalTrials.gov ID
- NCT02852161
- Acronym / sponsor ID
- MACE / 15109
- Conditions
- Barrett's Oesophagus, Oesophageal Varices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MACE | Experimental | Device: Magnet assissted capsule endoscopyMACE procedure |
| OGD | Active comparator | Device: Magnet assissted capsule endoscopyClinically indicated gastroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Due to have a clinically indicated gastroscopy Barrett's oesophagus/ oesophageal varices or Controls Able to give informed consent
Key exclusion criteria (1 listed)
- Unable to give consent Pregnant Pacemaker swallowing difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnet assissted capsule endoscopyPatients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day | Device | MACE, OGD |
Primary outcome
Diagnostic accuarcy
Time frame: immediate
endoscopic
1 secondary outcome
comfort
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 31678203Beg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krish Ragunath study chair
Nottingham University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnet assissted capsule endoscopy in people with Barrett's Oesophagus and Oesophageal Varices, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuarcy (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02852161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.