- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02883621
The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus (Kappa-III)
May 22, 2017 updated by: Mohamed Abdelhafez, Technical University of Munich
Comparison Between Standard Endoscopy and Cap Assisted Endoscopy for Diagnostic Yield 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bayern
-
Munich, Bayern, Germany, 81675
- II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A
subjects receive standard upper endoscopy
|
standard examination without using a cap
|
Experimental: Group B
subjects receive cap assisted upper endoscopy
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15 Minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohamed Abdelhafez, MD, II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
May 22, 2017
Study Registration Dates
First Submitted
August 21, 2016
First Submitted That Met QC Criteria
August 24, 2016
First Posted (Estimate)
August 30, 2016
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
May 22, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 218/16 s
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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