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OpenTrials
Completed

NCT Number: NCT02883621

The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus

Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip of the colonoscope, was proven to increase the adenoma detection rate during screening colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is still under investigations. The aim of this study is to compare the diagnostic yield of the CAE to the standard endoscopy in esophagus.

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Key information

Conditions

Endoscopic Diagnosis in Esophagus

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • indication for upper endoscopy
  • age over 18 years
  • ability to provide informed consent

Exclusion criteria

  • known or suspected upper gastrointestinal strictures
  • upper gastrointestinal bleeding
  • previous upper endoscopy during the last three months
  • American Society of Anesthesiologists class III or higher

Treatment and study plan

cap assisted upper endoscopy

Procedure

A soft plastic cap is attached to the tip of the scope to allow pressing of the folds and thus enhance the visualization.

Other names: cap fitted upper endoscopy

standard upper endoscopy

Procedure

standard examination without using a cap

Primary outcomes

  1. Diagnostic yield in esophagus

    Time frame: 15 Minutes

    All endoscopic abnormalities in esophagus which are detected during the examination in both groups will be documented, analyzed and compared

Secondary outcomes

  1. Overall diagnostic yield in upper gastrointestinal tract.

    Time frame: 15 Minutes

    All other endoscopic abnormalities outside the esophagus (stomach and duodenum) which are detected during the examination in both groups will be documented, analyzed and compared

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Gastroenterologische Fachpraxis Abdomen Prof. Dr. Manfred Kurjak
  • Gemeinschaftspraxis Dr. Schatke & Dr. Ott
  • Klinikum Freising
  • Klinikum Landshut-Achdorf
  • Rotkreuzklinikum München gGmbH
  • Städtisches Klinikum Neuperlach

Registry information

Official study title

Comparison Between Standard Endoscopy and Cap Assisted Endoscopy for Diagnostic Yield in Esophagus

Acronym: Kappa-III

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2016
Registry last updated
May 23, 2017

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.