Cap Assisted Upper Endoscopy to Visualize the Major Duode... | NCT02877797

Studies
Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla

NCT02877797

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Aug 24, 2016Estimated

Enrollment

101Actual

Phase

Not Applicable

Conditions

Visualisation and Evaluation of Ampulla of Vater

Interventions

Countries

Germany

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

Aug 2016

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

Feb 2016

Primary Completion Date

May 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Feb 29, 2016

First Submission Date that Met QC Criteria

Aug 19, 2016

First Posted Date

Aug 24, 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

Aug 19, 2016

Last Update Posted Date

Aug 24, 2016Estimated

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

Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
standard Esophagogastroduodenoscopy	No Intervention	standard Esophagogastroduodenoscopy
cap assisted Esophagogastroduodenoscopy	Experimental	cap assisted Esophagogastroduodenoscopy	Device: Cap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cap	Device	cap assisted esophagogastroduodenoscopy	cap assisted Esophagogastroduodenoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of complete visualisation of papilla duodeni major	visualisation: none, incomplete, complete	120 seconds

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic yield in the upper GI-tract	All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, Barret's esophagus, duodenal erosions, etc)	up to 10 minutes
time of investigation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication of Esophagogastroduodenoscopy independent from the study
Written informed
Age ≥ 18 years

Exclusion Criteria:

Absence of written informed consent
Contraindication or absence of informed consent regarding sedation with Propofol
Postoperativ changes of the upper GI-tract
Intention of endoscopic intervention
Suspicion of upper GI-bleeding
Suspicion of stenosis of the esophagus
Stent in the papilla duodeni major
ASA (American Society of Anesthesiologists) classification ≥ 3

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan von Delius	Technical University of Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar der Technischen Universität München		Munich	Bavaria	81675	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D003274	Contraceptive Devices, Female

Ancestor Terms

ID	Term
D003273	Contraceptive Devices
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided