- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02877797
Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla (Kappa-I)
August 19, 2016 updated by: Monther Bajbouj, Technical University of Munich
The Use of Cap Assisted Forward Viewing Esophagogastroduodenoscopy to Examine 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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
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
-
-
Bavaria
-
Munich, Bavaria, Germany, 81675
- 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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: standard Esophagogastroduodenoscopy
|
|
Experimental: cap assisted Esophagogastroduodenoscopy
|
cap assisted esophagogastroduodenoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of complete visualisation of papilla duodeni major
Time Frame: 120 seconds
|
visualisation: none, incomplete, complete
|
120 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
up to 10 minutes
|
time of investigation
Time Frame: up to 10 minutes
|
Duration of Esophagogastroduodenoscopy
|
up to 10 minutes
|
complication rate
Time Frame: up to one week
|
Any complications related to the examination within one week would be reported.
|
up to one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stefan von Delius, Technical University of Munich
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
February 1, 2016
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
February 29, 2016
First Submitted That Met QC Criteria
August 19, 2016
First Posted (Estimate)
August 24, 2016
Study Record Updates
Last Update Posted (Estimate)
August 24, 2016
Last Update Submitted That Met QC Criteria
August 19, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 14/16S
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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