The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus
Kappa-III
Comparison Between Standard Endoscopy and Cap Assisted Endoscopy for Diagnostic Yield in Esophagus
1 other identifier
interventional
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2016
CompletedFirst Posted
Study publicly available on registry
August 30, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2017
CompletedMay 23, 2017
May 1, 2017
7 months
August 21, 2016
May 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic yield in esophagus
All endoscopic abnormalities in esophagus which are detected during the examination in both groups will be documented, analyzed and compared
15 Minutes
Secondary Outcomes (1)
Overall diagnostic yield in upper gastrointestinal tract.
15 Minutes
Study Arms (2)
Group A
ACTIVE COMPARATORsubjects receive standard upper endoscopy
Group B
EXPERIMENTALsubjects receive cap assisted upper endoscopy
Interventions
A soft plastic cap is attached to the tip of the scope to allow pressing of the folds and thus enhance the visualization.
Eligibility Criteria
You may qualify if:
- indication for upper endoscopy
- age over 18 years
- ability to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technical University of Munichlead
- Klinikum Freisingcollaborator
- Klinikum Landshut-Achdorfcollaborator
- Städtisches Klinikum Neuperlachcollaborator
- Rotkreuzklinikum München gGmbHcollaborator
- Gemeinschaftspraxis Dr. Schatke & Dr. Ottcollaborator
- Gastroenterologische Fachpraxis Abdomen Prof. Dr. Manfred Kurjakcollaborator
Study Sites (1)
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed Abdelhafez, MD
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 21, 2016
First Posted
August 30, 2016
Study Start
September 1, 2016
Primary Completion
April 1, 2017
Study Completion
May 22, 2017
Last Updated
May 23, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share