Endoscopy Quality Study | NCT03351790

Studies
Endoscopy Quality Study

NCT03351790

Sponsor

Sandwell & West Birmingham Hospitals NHS Trust

Status

Unknown status

Last Update Posted

Nov 24, 2017Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Endoscopy

Interventions

Questionniare only

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2017Estimated

Primary Completion Date

Apr 2018Estimated

Completion Date

Apr 2019Estimated

First Submitted Date

Nov 20, 2017

First Submission Date that Met QC Criteria

Nov 20, 2017

First Posted Date

Nov 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2017

Last Update Posted Date

Nov 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nigel Trudgill, Consultant Gastroenterologist, Sandwell & West Birmingham Hospitals NHS TrustPrincipal Investigator

Lead Sponsor

Sandwell & West Birmingham Hospitals NHS TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All included participants		Patients that complete study questionnaire and have endoscopy recorded.	Other: Questionniare only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionniare only	Other	A pre-procedure questionnaire will be completed by all participants	All included participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
View seen at endoscopy	This is the quality of view seen at endoscopy based upon a bespoke scale	Endoscopy will be performed as booked for standard care. This will be the same day as consent.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient booked for routine OGD

Exclusion Criteria:

Inpatient endoscopy
Barretts surveillance endoscopy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients referred for upper GI endoscopy (OGD)

Sampling Method

Non-Probability Sample