A Survey of the Indications for Esophagogastroduodenoscop... | NCT02789514

Studies
A Survey of the Indications for Esophagogastroduodenoscopy (EGD) in Children's Hospital of Fudan University

NCT02789514

Sponsor

Children's Hospital of Fudan University

Status

Completed

Last Update Posted

Feb 6, 2017Estimated

Enrollment

1,303Actual

Phase

Not provided

Conditions

Digestive System Abnormalities

Interventions

Not provided

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

May 19, 2016

First Submission Date that Met QC Criteria

Jun 2, 2016

First Posted Date

Jun 3, 2016Estimated

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

Feb 2, 2017

Last Update Posted Date

Feb 6, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ying HUANG, The director of gastroenterology of Children's Hospital of Fudan University, Children's Hospital of Fudan UniversityPrincipal Investigator

Lead Sponsor

Children's Hospital of Fudan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. The investigators want to find which symptoms can support for positive endoscopic findings.

Detailed Description

Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. And there are indications for EGD. Here, investigators want to find which symptoms can strongly support for positive endoscopy findings. So, investigators design the study to record the symptoms in detail and diagnosis, and then analysis symptoms and the rate of endoscopic findings.

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

1,303Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
children		Investigators give observation to the patients who need esophagogastroduodenoscopic procedures.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Questionnaires about the indications for esophagogastroduodenoscopic procedures were collected	The content of questionnaire include the symptoms which prompt for the esophagogastroduodenoscopic procedure, and the diagnosis. Then investigators will analysis the relationship between symptom and diagnosis.	May, 2016-August, 2016

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All of the patients need esophagogastroduodenoscopic procedures

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

17 Years

Standard Ages

Child

Study Population

All of the patients need esophagogastroduodenoscopic procedures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ying Huang, doctor	Children's Hospital of Fudan University	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004065	Digestive System Abnormalities

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided