Endoscopic Diagnosis in EsophagusKappa-IIINCT02883621
The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus
A study testing cap assisted upper endoscopy and standard upper endoscopy in people with Endoscopic Diagnosis in Esophagus, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Diagnosis in Esophagus
- What is being tested?
- cap assisted upper endoscopy and standard upper endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to 22 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indication for upper endoscopy
- age over 18 years
- ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
About this study
Official title: 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.
- Conditions
- Endoscopic Diagnosis in Esophagus
- Being tested
- cap assisted upper endoscopy, standard upper endoscopy
- Keywords
- upper endoscopy, cap assisted endoscopy, esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cap assisted upper endoscopyProcedure or surgery
Also called cap fitted 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.
standard upper endoscopyProcedure or surgery
standard examination without using a cap
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | subjects receive standard upper endoscopy Receives: Procedure: standard upper endoscopy |
| Group B | Experimental | subjects receive cap assisted upper endoscopy Receives: Procedure: cap assisted upper endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield in esophagus
All endoscopic abnormalities in esophagus which are detected during the examination in both groups will be documented, analyzed and compared
Measured: 15 Minutes
Secondary outcomes (1)
Overall diagnostic yield in upper gastrointestinal tract.
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
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Diagnosis in EsophagusStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Freising, Klinikum Landshut-Achdorf, Städtisches Klinikum Neuperlach, Rotkreuzklinikum München gGmbH, Gemeinschaftspraxis Dr. Schatke & Dr. Ott, Gastroenterologische Fachpraxis Abdomen Prof. Dr. Manfred Kurjak
- Responsible party
- Principal investigator, Mohamed Abdelhafez, Technical University of Munich
- Investigators
- Mohamed Abdelhafez, MD, Principal investigator, II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883621
- Sponsor's protocol ID
- 218/16 s
- Acronym
- Kappa-III
- Status last verified
- May 2017
- First submitted
- 21 Aug 2016
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Standard Endoscopy and Cap Assisted Endoscopy for Diagnostic Yield in Esophagus
- ClinicalTrials.gov ID
- NCT02883621
- Acronym / sponsor ID
- Kappa-III / 218/16 s
- Conditions
- Endoscopic Diagnosis in Esophagus
- Keywords
- upper endoscopy, cap assisted endoscopy, esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Klinikum Freising, Klinikum Landshut-Achdorf, Städtisches Klinikum Neuperlach, Rotkreuzklinikum München gGmbH, Gemeinschaftspraxis Dr. Schatke & Dr. Ott, Gastroenterologische Fachpraxis Abdomen Prof. Dr. Manfred Kurjak
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: standard upper endoscopysubjects receive standard upper endoscopy |
| Group B | Experimental | Procedure: cap assisted upper endoscopysubjects receive cap assisted upper endoscopy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- indication for upper endoscopy
- age over 18 years
- ability to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cap assisted upper endoscopyAlso: cap fitted upper endoscopyA soft plastic cap is attached to the tip of the scope to allow pressing of the folds and thus enhance the visualization. | Procedure or surgery | Group B |
| standard upper endoscopystandard examination without using a cap | Procedure or surgery | Group A |
Primary outcome
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
1 secondary outcome
Overall diagnostic yield in upper gastrointestinal tract.
Time frame: 15 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abdelhafez, MD principal investigator
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cap assisted upper endoscopy and standard upper endoscopy in people with Endoscopic Diagnosis in Esophagus, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield in esophagus (time frame: 15 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.