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OpenTrials
Completed

NCT Number: NCT02877797

Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla

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.

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Key information

Conditions

Visualisation and Evaluation of Ampulla of Vater

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cap

Device

cap assisted esophagogastroduodenoscopy

Primary outcomes

  1. Rate of complete visualisation of papilla duodeni major

    Time frame: 120 seconds

    visualisation: none, incomplete, complete

Secondary outcomes

  1. Diagnostic yield in the upper GI-tract

    Time frame: up to 10 minutes

    All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, Barret's esophagus, duodenal erosions, etc)

  2. time of investigation

    Time frame: up to 10 minutes

    Duration of Esophagogastroduodenoscopy

  3. complication rate

    Time frame: up to one week

    Any complications related to the examination within one week would be reported.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

The Use of Cap Assisted Forward Viewing Esophagogastroduodenoscopy to Examine the Major Duodenal Papilla

Acronym: Kappa-I

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 24, 2016
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.