Visualisation and Evaluation of Ampulla of VaterKappa-INCT02877797
Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla
A study testing Cap in people with Visualisation and Evaluation of Ampulla of Vater, run by Technical University of Munich at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visualisation and Evaluation of Ampulla of Vater
- What is being tested?
- Cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of Esophagogastroduodenoscopy independent from the study
- Written informed
- Age ≥ 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
About this study
Official title: 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.
- Being tested
- Cap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapDevice
cap assisted esophagogastroduodenoscopy
| Study group | Role | What they receive |
|---|---|---|
| standard Esophagogastroduodenoscopy | No intervention | standard Esophagogastroduodenoscopy |
| cap assisted Esophagogastroduodenoscopy | Experimental | cap assisted Esophagogastroduodenoscopy Receives: Device: Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete visualisation of papilla duodeni major
visualisation: none, incomplete, complete
Measured: 120 seconds
Secondary outcomes (3)
Diagnostic yield in the upper GI-tract
All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, Barret's esophagus, duodenal erosions, etc)
Measured: up to 10 minutes
time of investigation
Duration of Esophagogastroduodenoscopy
Measured: up to 10 minutes
complication rate
Any complications related to the examination within one week would be reported.
Measured: up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visualisation and Evaluation of Ampulla of VaterStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monther Bajbouj, Technical University of Munich
- Investigators
- Stefan von Delius, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877797
- Sponsor's protocol ID
- 14/16S
- Acronym
- Kappa-I
- Status last verified
- Aug 2016
- First submitted
- 29 Feb 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Cap Assisted Forward Viewing Esophagogastroduodenoscopy to Examine the Major Duodenal Papilla
- ClinicalTrials.gov ID
- NCT02877797
- Acronym / sponsor ID
- Kappa-I / 14/16S
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard Esophagogastroduodenoscopy | No intervention | –standard Esophagogastroduodenoscopy |
| cap assisted Esophagogastroduodenoscopy | Experimental | Device: Capcap assisted Esophagogastroduodenoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication of Esophagogastroduodenoscopy independent from the study
- Written informed
- Age ≥ 18 years
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Capcap assisted esophagogastroduodenoscopy | Device | cap assisted Esophagogastroduodenoscopy |
Primary outcome
Rate of complete visualisation of papilla duodeni major
Time frame: 120 seconds
visualisation: none, incomplete, complete
3 secondary outcomes
Diagnostic yield in the upper GI-tract
Time frame: up to 10 minutes
time of investigation
Time frame: up to 10 minutes
complication rate
Time frame: up to one week
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 24 Aug 2016.
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.
Stefan von Delius principal investigator
Technical University of Munich
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 in people with Visualisation and Evaluation of Ampulla of Vater, 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 8 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 24 Aug 2016. 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?
Rate of complete visualisation of papilla duodeni major (time frame: 120 seconds). 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 24 Aug 2016.