EndoscopyNCT03351790
Endoscopy Quality Study
An observational study of Endoscopy, run by Sandwell & West Birmingham Hospitals NHS Trust.
Trial summary
This study seeks to establish factors that influence the view at endoscopy. To achieve this patients, who have been already booked for endoscopy, will complete a questionnaire prior to their procedure. Demographic and endoscopist factors will also be ascertained. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endoscopy
- What is being tested?
- Questionniare only
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Apr 2019
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients referred for upper GI endoscopy (OGD)
Who may be able to join
- Any patient booked for routine OGD
Who cannot join
- Inpatient endoscopy
- Barretts surveillance endoscopy
About this study
Official title: Assessing the Quality of Upper Gastrointestinal Endoscopy - Factors That Affect it and Validation of a Bespoke Mucosal Visual Scale
This study seeks to establish factors that influence the view at endoscopy. To achieve this patients, who have been already booked for endoscopy, will complete a questionnaire prior to their procedure. Demographic and endoscopist factors will also be ascertained.
The view at endoscopy will then be reviewed and scored against a rating scale, which will be validated as a first phase of the study. Factors can then be sought that are associated with a good endoscopic view.
- Conditions
- Endoscopy
- Being tested
- Questionniare only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionniare onlyOther
A pre-procedure questionnaire will be completed by all participants
| Study group | Role | What they receive |
|---|---|---|
| All included participants | Patients that complete study questionnaire and have endoscopy recorded. Receives: Other: Questionniare only |
What is being measured
The primary outcome is the main question the study is designed to answer.
View seen at endoscopy
This is the quality of view seen at endoscopy based upon a bespoke scale
Measured: Endoscopy will be performed as booked for standard care. This will be the same day as consent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startNov 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigel Trudgill, Sandwell & West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351790
- Sponsor's protocol ID
- 15GAST29
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Quality of Upper Gastrointestinal Endoscopy - Factors That Affect it and Validation of a Bespoke Mucosal Visual Scale
- ClinicalTrials.gov ID
- NCT03351790
- Acronym / sponsor ID
- 15GAST29
- Conditions
- Endoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 24 Nov 2017 (actual)
- 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.
This study seeks to establish factors that influence the view at endoscopy. To achieve this patients, who have been already booked for endoscopy, will complete a questionnaire prior to their procedure. Demographic and endoscopist factors will also be ascertained.
The view at endoscopy will then be reviewed and scored against a rating scale, which will be validated as a first phase of the study. Factors can then be sought that are associated with a good endoscopic view.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All included participants | – | Other: Questionniare onlyPatients that complete study questionnaire and have endoscopy recorded. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients referred for upper GI endoscopy (OGD)
Key inclusion criteria (1 listed)
- Any patient booked for routine OGD
Key exclusion criteria (2 listed)
- Inpatient endoscopy
- Barretts surveillance endoscopy
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 |
|---|---|---|
| Questionniare onlyA pre-procedure questionnaire will be completed by all participants | Other | All included participants |
Primary outcome
View seen at endoscopy
Time frame: Endoscopy will be performed as booked for standard care. This will be the same day as consent.
This is the quality of view seen at endoscopy based upon a bespoke scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopy, run by Sandwell & West Birmingham Hospitals NHS Trust.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
View seen at endoscopy (time frame: Endoscopy will be performed as booked for standard care. This will be the same day as consent.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2017.