Biliary Tract DiseasesEmeRaldNCT06683716
SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0
A study testing Training in presence of the instructor and Telemedically training by an instructor in people with Biliary Tract Diseases and Pancreatic Diseases, run by Helios Kliniken Schwerin at 1 site in Germany.
Trial summary
The aim of this prospective randomized study is to evaluate whether telemedical assistance via SmartGlasses is equivalent to physical presence in teaching Endoscopic Retrograde Cholangiopancreaticography (ERCP) in terms of examination success and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Diseases, Pancreatic Diseases
- What is being tested?
- Training in presence of the instructor and Telemedically training by an instructor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients aged ≥ 18 years without previous papillotomy Exclusion criteria
- Cannulation of the minor papilla necessary
- Significant comorbidity
- Haemodynamic instability
- Pregnant women
- Refusal or inability to give written informed consent for the study
- Instructor had to perform the examination himself/herself
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Helios Kliniken Schwerin
Schwerin, Mecklenburg-Vorpommern, 19055
Jörg-Peter Ritz (Medical director of the whole hospital), Prof. Dr. med., +49-385-520-2050, Joerg-Peter.Ritz@helios-gesundheit.de
Jens Nürnberger, Prof. Dr. med., +49-385-520-2050, jens.nuernberger@helios-gesundheit.de
About this study
Official title: Remote Assistance Via Smart Glasses Compared to In-person Assistance for Cannulation of the Native Papilla During Endoscopic Retrograde Cholangiopancreatography
The aim of this prospective randomized study is to evaluate whether telemedical assistance via SmartGlasses is equivalent to physical presence in teaching Endoscopic Retrograde Cholangiopancreaticography (ERCP) in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds/minutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).
Read the detailed description
In sparsely populated regions of a country and where there is a lack of experienced specialists, it may not always be possible to have an experienced ERCP examiner present during an examination. Therefore, telemedical examination assistance via a connection to data glasses worn by the examiner is a possible option to replace the physical presence of an instructor or experienced ERCP examiner.
The aim of this prospective randomized study is to evaluate whether telemedical assistance via smart glasses is equivalent to physical presence in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds/minutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).
In addition to other efficacy endpoints, adverse events, which are expected to be rare, will be documented at 48-hour intervals and calculated as a rate. Telemedical 'live' support of an ERCP via data glasses has not yet been demonstrated or tested in a trial. To ensure the safety of the examination under these circumstances, the training examiner is present in the neighbouring room and can physically assist or take over the examination at any time if necessary.
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Being tested
- Training in presence of the instructor, Telemedically training by an instructor
- Keywords
- Telemedicine, Training Technique, Cholangiopancreatography, Endoscopic Retrograde
- Medical subject headings
- Biliary Tract Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in presence of the instructorOther
The instructor gives the trainee instructions for the examination while he/she is present in the examination room.
Telemedically training by an instructorOther
The trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses
| Study group | Role | What they receive |
|---|---|---|
| Training in presence | Active comparator | The instructor teaches the trainee in physical presence during the ERCP Receives: Other: Training in presence of the instructor |
| Telemedical training | Experimental | The instructor teaches the trainee telemedically by using smartglasses during the ERCP Receives: Other: Telemedically training by an instructor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Papilla cannulation time
Time to cannulate the native papilla during ERCP
Measured: During the intervention: from the stable visualisation of the papilla until the successful cannulation of the papilla, assessed up to 60 minutes
Secondary outcomes (1)
Adverse events during and after ERCP
All adverse events that occur during ERCP and after ERCP: number (n)
Measured: Time interval between insertion of the endoscope through the mouth up to 48 hours after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start2 Jan 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised non-inferiority trial comparing two training conditions in gastrointestinal endoscopy (ERCP)
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Kliniken Schwerin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Daniel Schmitz, Helios Kliniken Schwerin
- Investigators
- Daniel Schmitz, Dr.med., Principal investigator, Helios Kliniken Schwerin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683716
- Sponsor's protocol ID
- Helios SN GAS 2024-11-01
- Acronym
- EmeRald
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to share the IPD in a public repository such as re3data.org
Publications
Pan Y, Zhao L, Leung J, Zhang R, Luo H, Wang X, Liu Z, Wan B, Tao Q, Yao S, Hui N, Fan D, Wu K, Guo X. Appropriate time for selective biliary cannulation by trainees during ERCP--a randomized trial. Endoscopy. 2015 Aug;47(8):688-95. doi: 10.1055/s-0034-1391564. Epub 2015 Mar 6.
PubMed 25750038Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.
PubMed 27299638Biancheri P, Soriani P, Gabbani T, Bonura GF, Manno M. Smart glasses: Taking GI endoscopy to the metaverse era. Dig Liver Dis. 2023 May;55(5):692-693. doi: 10.1016/j.dld.2023.02.001. Epub 2023 Feb 26. No abstract available.
PubMed 36849287
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Assistance Via Smart Glasses Compared to In-person Assistance for Cannulation of the Native Papilla During Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT06683716
- Acronym / sponsor ID
- EmeRald / Helios SN GAS 2024-11-01
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Keywords
- Telemedicine, Training Technique, Cholangiopancreatography, Endoscopic Retrograde
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Helios Kliniken SchwerinUniversity, hospital or other
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- 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.
The aim of this prospective randomized study is to evaluate whether telemedical assistance via SmartGlasses is equivalent to physical presence in teaching Endoscopic Retrograde Cholangiopancreaticography (ERCP) in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds/minutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).
Detailed description
In sparsely populated regions of a country and where there is a lack of experienced specialists, it may not always be possible to have an experienced ERCP examiner present during an examination. Therefore, telemedical examination assistance via a connection to data glasses worn by the examiner is a possible option to replace the physical presence of an instructor or experienced ERCP examiner.
The aim of this prospective randomized study is to evaluate whether telemedical assistance via smart glasses is equivalent to physical presence in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds/minutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).
In addition to other efficacy endpoints, adverse events, which are expected to be rare, will be documented at 48-hour intervals and calculated as a rate. Telemedical 'live' support of an ERCP via data glasses has not yet been demonstrated or tested in a trial. To ensure the safety of the examination under these circumstances, the training examiner is present in the neighbouring room and can physically assist or take over the examination at any time if necessary.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomised non-inferiority trial comparing two training conditions in gastrointestinal endoscopy (ERCP)
| Arm | Type | Receives |
|---|---|---|
| Training in presence | Active comparator | Other: Training in presence of the instructorThe instructor teaches the trainee in physical presence during the ERCP |
| Telemedical training | Experimental | Other: Telemedically training by an instructorThe instructor teaches the trainee telemedically by using smartglasses during the ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients aged ≥ 18 years without previous papillotomy Exclusion criteria
- Cannulation of the minor papilla necessary
- Significant comorbidity
- Haemodynamic instability
- Pregnant women
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Training in presence of the instructorThe instructor gives the trainee instructions for the examination while he/she is present in the examination room. | Other | Training in presence |
| Telemedically training by an instructorThe trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses | Other | Telemedical training |
Primary outcome
Papilla cannulation time
Time frame: During the intervention: from the stable visualisation of the papilla until the successful cannulation of the papilla, assessed up to 60 minutes
Time to cannulate the native papilla during ERCP
1 secondary outcome
Adverse events during and after ERCP
Time frame: Time interval between insertion of the endoscope through the mouth up to 48 hours after ERCP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 25750038Pan Y, Zhao L, Leung J, Zhang R, Luo H, Wang X, Liu Z, Wan B, Tao Q, Yao S, Hui N, Fan D, Wu K, Guo X. Appropriate time for selective biliary cannulation by trainees during ERCP--a randomized trial. Endoscopy. 2015 Aug;47(8):688-95. doi: 10.1055/s-0034-1391564. Epub 2015 Mar 6.
- Background: PubMed 27299638Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.
- Background: PubMed 36849287Biancheri P, Soriani P, Gabbani T, Bonura GF, Manno M. Smart glasses: Taking GI endoscopy to the metaverse era. Dig Liver Dis. 2023 May;55(5):692-693. doi: 10.1016/j.dld.2023.02.001. Epub 2023 Feb 26. No abstract available.
- Individual participant dataSharing planned: Yes. It is planned to share the IPD in a public repository such as re3data.org
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RecruitingPhase 2
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Not yet recruitingPhase 4
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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.
Daniel Schmitz, Dr.med. principal investigator
Helios Kliniken Schwerin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in presence of the instructor and Telemedically training by an instructor in people with Biliary Tract Diseases and Pancreatic Diseases, run by Helios Kliniken Schwerin 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 7 inclusion and 0 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: opening soon, as of the sponsor's last update on 12 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Schmitz, Dr. med. (+49-385-520-2601, daniel.schmitz@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Papilla cannulation time (time frame: During the intervention: from the stable visualisation of the papilla until the successful cannulation of the papilla, assessed up to 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683716, which also lists 3 linked publications.
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 12 Nov 2024.