Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla

NCT ID: NCT02877797

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Visualisation and Evaluation of Ampulla of Vater

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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standard Esophagogastroduodenoscopy

standard Esophagogastroduodenoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

cap assisted Esophagogastroduodenoscopy

cap assisted Esophagogastroduodenoscopy

Group Type EXPERIMENTAL

Cap

Intervention Type DEVICE

cap assisted esophagogastroduodenoscopy

Interventions

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Cap

cap assisted esophagogastroduodenoscopy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Monther Bajbouj

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan von Delius

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Locations

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Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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14/16S

Identifier Type: -

Identifier Source: org_study_id

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