Physicians Gastroscopy TrainingEFFEKTRANCT04898803
How Effective Can a Simulator-Based Training Course For Beginners In Endoscopy Be Made?
An observational study of Physicians Gastroscopy Training, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial summary
The aim of the study is to clarify whether physicians training for gastroscopies benefit from a modified training course. The duration and type of optimized use of training simulators as part of a basic gastroscopy course can lead to a higher level of competence in patient examinations (main target parameters) than… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physicians Gastroscopy Training
- What is being tested?
- conventional DGVS training and extended simulator training
- How many people
- 32 participants
- Where
- 2 sitesGermany
- Study dates
- 3 Aug 2020to 14 Dec 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: see above
Who may be able to join
- Trainees:
- licensed physicians in internal medicine, surgery or gastroenterology,
- no endoscopic or laparoscopic experience
- informed consent
- Patient's endoscopies:
- all patients > 18 years of age who are capable of being informed and have a clinical indication for esophagogastroduodenoscopy
- informed consent
- simple examination expected
Who cannot join
- Patient's endoscopies:
- difficult examination expected
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Eppendorf
Hamburg, 20246
Albertinen Krankenhaus
Hamburg, 22457
About this study
The aim of the study is to clarify whether physicians training for gastroscopies benefit from a modified training course. The duration and type of optimized use of training simulators as part of a basic gastroscopy course can lead to a higher level of competence in patient examinations (main target parameters) than conventional use. Further goals are the comparison of the theoretical knowledge gained through the modified versus conventional course, as well as the self-assessment of the participants.
Read the detailed description
Training in interventional medicine, including surgery and endoscopy, is usually still done on the patient, under more or less qualified supervision. Previous exercises on models or simulators are still the exception and only reach around 40% of colleagues in countries with defined curricula and guidelines.The simulator-based training, however, offers a protected area in which, without risk to the patient, initial learning successes in flexible endoscopy can be achieved according to the "trial and error" principle. Various studies have shown that initial training on the simulator is beneficial: Physicians trained on the simulator require less support during the first examinations on the patient, less examination time, can reach and identify anatomical landmarks better and have better hand-eye coordination.If the simulator training is embedded in a structured curriculum, greater successes seem to be achieved in comparison to unstructured training. The feedback during the training is also a positive influencing factor; this should ideally take place at the end of each unit. It is also possible to use a simulator to train defined partial performances and to repeat these in the required amount. A step-by-step structure with defined intermediate goals, in the sense of mastery learning, also increases effectiveness.There is little data on the optimal duration or the saturation of the learning curve in simulator training. In one study the learning curve flattened after 60 simulated colonoscopies. Another study showed a gradual improvement up to 6 hours on the simulator. It also used threshold values for the performance score to define the optimal point in time for transition to patient-based training.
The current certification for the standardization of the nationwide endoscopy training courses by the German Gastroenterological Society (DGVS), provides for 4 hours of training on the simulator, including one hour of introduction. With an also recommended maximum group size of 4 participants per simulator, this corresponds to a duration of only 1 hour of effective simulator training per trainee. There are no recommendations for structuring simulator trainings or the type of simulators used.
The main aim of the present study is to find out whether it is possible to improve this situation without unrealistically extending the training and course times.
Trainees will randomly attend either a conventional training or an extended simulator training. Immediately after the course, in accordance with the DGVS guidelines, an examination of the same content for both groups to inquire the theoretical knowledge is done.1-5 weeks after completion of the training course, an evaluation of the endoscopic skills of the participants takes place. It is done on the patient, under supervision, as is currently customary in everyday clinical training. After a one-day introduction through observation of routine gastroscopies, two gastroscopies are then carried out. Two endoscopists independently assess the performance based on a Video record of the examination. All endoscopists involved in supervision or assessment are blinded to the trainee's group membership..
- Conditions
- Physicians Gastroscopy Training
- Being tested
- conventional DGVS training, extended simulator training
- Keywords
- simulator training, gastroscopy training, physicians training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional DGVS trainingOther
see above
extended simulator trainingOther
see above
| Study group | Role | What they receive |
|---|---|---|
| conventional gastroscopy training course | physicians receive the DGVS-recommended training, consisting of a 2-day course with 1 hour of simulator training Receives: Other: conventional DGVS training | |
| extended simulator course | physicians receive a two-day simulator course with a minimum of 6 hours of simulator training per trainee, structured in stages in the sense of progressive or mastery learning. The initial part of the training will be part-task training. Receives: Other: extended simulator training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) competence score competence score
Comparison of the GAGES competence score of the video-based observations of the first two patient examinations, each assessed by two endoscopists. To be valuated: intubation of esophagus, scope navigation, ability to keep a clear endoscope field, instrumentation, quality of examination. Best score each question 5 pts, worst 1 pt.
Measured: one to five weeks after training course
Non-inferiority of the new training procedure
Non-inferiority of the new training procedure in the final exams according to DGVS criteria
Measured: through study completion, approximately 1 year
Secondary outcomes (3)
competence assessment Direct Observation of Procedural Skills (DOPS) by Joint Advisory Group on Gastrointestinal Endoscopy (JAG)
Comparison of the JAG DOPS competence level of the video-based observations of the first two patient examinations, each assessed by two endoscopists. Assession of trainee's needed level of supervision at pre- and post procedure, insertion and withdrawal, visualisation, management of findings, and non-technical skills. Each has 4 values, best is "Competent for independent practice", worst is "maximal supervision"
Measured: one to five weeks after training course
Assessment of Competency in Endoscopy (ACE)
Comparison of the ACE competence evaluation of the video-based observations of the first two patient examinations, each assessed by two endoscopists.
Measured: one to five weeks after training course
mean self-assessment by Visual Analog Scale (VAS)
VAS after the first two patient examinations. This enables an assessment of the stress level and ultimately a measurement of the cognitive load of the subject. To be evaluated on a non-scaled line from "do not agree at all" to "totally agree".
Measured: one to five weeks after training course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start3 Aug 2020
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Physicians Gastroscopy TrainingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Deutschland GmbH
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Rösch, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898803
- Sponsor's protocol ID
- PV7217
- Acronym
- EFFEKTRA
- Status last verified
- Jun 2023
- First submitted
- 25 Jan 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amiot A, Conroy G, Le Baleur Y, Winkler J, Palazzo M, Treton X. Endoscopic training: A nationwide survey of French fellows in gastroenterology. Clin Res Hepatol Gastroenterol. 2018 Apr;42(2):160-167. doi: 10.1016/j.clinre.2017.08.005. Epub 2017 Sep 18.
PubMed 28927657Jirapinyo P, Thompson CC. Current status of endoscopic simulation in gastroenterology fellowship training programs. Surg Endosc. 2015 Jul;29(7):1913-9. doi: 10.1007/s00464-014-3884-0. Epub 2014 Oct 11.
PubMed 25303910Ende A, Zopf Y, Konturek P, Naegel A, Hahn EG, Matthes K, Maiss J. Strategies for training in diagnostic upper endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2012 Feb;75(2):254-60. doi: 10.1016/j.gie.2011.07.063. Epub 2011 Dec 7.
PubMed 22153875Haycock A, Koch AD, Familiari P, van Delft F, Dekker E, Petruzziello L, Haringsma J, Thomas-Gibson S. Training and transfer of colonoscopy skills: a multinational, randomized, blinded, controlled trial of simulator versus bedside training. Gastrointest Endosc. 2010 Feb;71(2):298-307. doi: 10.1016/j.gie.2009.07.017. Epub 2009 Nov 3.
PubMed 19889408Sedlack RE, Kolars JC, Alexander JA. Computer simulation training enhances patient comfort during endoscopy. Clin Gastroenterol Hepatol. 2004 Apr;2(4):348-52. doi: 10.1016/s1542-3565(04)00067-9.
PubMed 15067632Shirai Y, Yoshida T, Shiraishi R, Okamoto T, Nakamura H, Harada T, Nishikawa J, Sakaida I. Prospective randomized study on the use of a computer-based endoscopic simulator for training in esophagogastroduodenoscopy. J Gastroenterol Hepatol. 2008 Jul;23(7 Pt 1):1046-50. doi: 10.1111/j.1440-1746.2008.05457.x. Epub 2008 Jun 28.
PubMed 18554236Ahlberg G, Hultcrantz R, Jaramillo E, Lindblom A, Arvidsson D. Virtual reality colonoscopy simulation: a compulsory practice for the future colonoscopist? Endoscopy. 2005 Dec;37(12):1198-204. doi: 10.1055/s-2005-921049.
PubMed 16329017Cohen J, Cohen SA, Vora KC, Xue X, Burdick JS, Bank S, Bini EJ, Bodenheimer H, Cerulli M, Gerdes H, Greenwald D, Gress F, Grosman I, Hawes R, Mullin G, Schnoll-Sussman F, Starpoli A, Stevens P, Tenner S, Villanueva G. Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy. Gastrointest Endosc. 2006 Sep;64(3):361-8. doi: 10.1016/j.gie.2005.11.062.
PubMed 16923483Di Giulio E, Fregonese D, Casetti T, Cestari R, Chilovi F, D'Ambra G, Di Matteo G, Ficano L, Delle Fave G. Training with a computer-based simulator achieves basic manual skills required for upper endoscopy: a randomized controlled trial. Gastrointest Endosc. 2004 Aug;60(2):196-200. doi: 10.1016/s0016-5107(04)01566-4.
PubMed 15278044Ferlitsch A, Schoefl R, Puespoek A, Miehsler W, Schoeniger-Hekele M, Hofer H, Gangl A, Homoncik M. Effect of virtual endoscopy simulator training on performance of upper gastrointestinal endoscopy in patients: a randomized controlled trial. Endoscopy. 2010 Dec;42(12):1049-56. doi: 10.1055/s-0030-1255818. Epub 2010 Oct 22.
PubMed 20972956Maiss J, Millermann L, Heinemann K, Naegel A, Peters A, Matthes K, Hahn EG, Hochberger J. The compactEASIE is a feasible training model for endoscopic novices: a prospective randomised trial. Dig Liver Dis. 2007 Jan;39(1):70-8; discussion 79-80. doi: 10.1016/j.dld.2006.07.007. Epub 2006 Aug 30.
PubMed 16942923McIntosh KS, Gregor JC, Khanna NV. Computer-based virtual reality colonoscopy simulation improves patient-based colonoscopy performance. Can J Gastroenterol Hepatol. 2014 Apr;28(4):203-6. doi: 10.1155/2014/804367.
PubMed 24729994Park J, MacRae H, Musselman LJ, Rossos P, Hamstra SJ, Wolman S, Reznick RK. Randomized controlled trial of virtual reality simulator training: transfer to live patients. Am J Surg. 2007 Aug;194(2):205-11. doi: 10.1016/j.amjsurg.2006.11.032.
PubMed 17618805Sedlack RE, Kolars JC. Computer simulator training enhances the competency of gastroenterology fellows at colonoscopy: results of a pilot study. Am J Gastroenterol. 2004 Jan;99(1):33-7. doi: 10.1111/j.1572-0241.2004.04007.x.
PubMed 14687137Tuggy ML. Virtual reality flexible sigmoidoscopy simulator training: impact on resident performance. J Am Board Fam Pract. 1998 Nov-Dec;11(6):426-33. doi: 10.3122/jabfm.11.6.426.
PubMed 9875997
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Effective Can a Simulator-Based Training Course For Beginners In Endoscopy Be Made?
- ClinicalTrials.gov ID
- NCT04898803
- Acronym / sponsor ID
- EFFEKTRA / PV7217
- Conditions
- Physicians Gastroscopy Training
- Keywords
- simulator training, gastroscopy training, physicians training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Olympus Deutschland GmbH
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 24 May 2021 (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 the study is to clarify whether physicians training for gastroscopies benefit from a modified training course. The duration and type of optimized use of training simulators as part of a basic gastroscopy course can lead to a higher level of competence in patient examinations (main target parameters) than conventional use. Further goals are the comparison of the theoretical knowledge gained through the modified versus conventional course, as well as the self-assessment of the participants.
Detailed description
Training in interventional medicine, including surgery and endoscopy, is usually still done on the patient, under more or less qualified supervision. Previous exercises on models or simulators are still the exception and only reach around 40% of colleagues in countries with defined curricula and guidelines.The simulator-based training, however, offers a protected area in which, without risk to the patient, initial learning successes in flexible endoscopy can be achieved according to the "trial and error" principle. Various studies have shown that initial training on the simulator is beneficial: Physicians trained on the simulator require less support during the first examinations on the patient, less examination time, can reach and identify anatomical landmarks better and have better hand-eye coordination.If the simulator training is embedded in a structured curriculum, greater successes seem to be achieved in comparison to unstructured training. The feedback during the training is also a positive influencing factor; this should ideally take place at the end of each unit. It is also possible to use a simulator to train defined partial performances and to repeat these in the required amount. A step-by-step structure with defined intermediate goals, in the sense of mastery learning, also increases effectiveness.There is little data on the optimal duration or the saturation of the learning curve in simulator training. In one study the learning curve flattened after 60 simulated colonoscopies. Another study showed a gradual improvement up to 6 hours on the simulator. It also used threshold values for the performance score to define the optimal point in time for transition to patient-based training.
The current certification for the standardization of the nationwide endoscopy training courses by the German Gastroenterological Society (DGVS), provides for 4 hours of training on the simulator, including one hour of introduction. With an also recommended maximum group size of 4 participants per simulator, this corresponds to a duration of only 1 hour of effective simulator training per trainee. There are no recommendations for structuring simulator trainings or the type of simulators used.
The main aim of the present study is to find out whether it is possible to improve this situation without unrealistically extending the training and course times.
Trainees will randomly attend either a conventional training or an extended simulator training. Immediately after the course, in accordance with the DGVS guidelines, an examination of the same content for both groups to inquire the theoretical knowledge is done.1-5 weeks after completion of the training course, an evaluation of the endoscopic skills of the participants takes place. It is done on the patient, under supervision, as is currently customary in everyday clinical training. After a one-day introduction through observation of routine gastroscopies, two gastroscopies are then carried out. Two endoscopists independently assess the performance based on a Video record of the examination. All endoscopists involved in supervision or assessment are blinded to the trainee's group membership..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional gastroscopy training course | – | Other: conventional DGVS trainingphysicians receive the DGVS-recommended training, consisting of a 2-day course with 1 hour of simulator training |
| extended simulator course | – | Other: extended simulator trainingphysicians receive a two-day simulator course with a minimum of 6 hours of simulator training per trainee, structured in stages in the sense of progressive or mastery learning. The initial part of the training will be part-task training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- see above
Key inclusion criteria (8 listed)
- licensed physicians in internal medicine, surgery or gastroenterology,
- no endoscopic or laparoscopic experience
- informed consent
- all patients > 18 years of age who are capable of being informed and have a clinical indication for esophagogastroduodenoscopy
- informed consent
Key exclusion criteria (2 listed)
- difficult examination expected
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 |
|---|---|---|
| conventional DGVS trainingsee above | Other | conventional gastroscopy training course |
| extended simulator trainingsee above | Other | extended simulator course |
Primary outcome
Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) competence score competence score
Time frame: one to five weeks after training course
Comparison of the GAGES competence score of the video-based observations of the first two patient examinations, each assessed by two endoscopists. To be valuated: intubation of esophagus, scope navigation, ability to keep a clear endoscope field, instrumentation, quality of examination. Best score each question 5 pts, worst 1 pt.
Non-inferiority of the new training procedure
Time frame: through study completion, approximately 1 year
Non-inferiority of the new training procedure in the final exams according to DGVS criteria
3 secondary outcomes
competence assessment Direct Observation of Procedural Skills (DOPS) by Joint Advisory Group on Gastrointestinal Endoscopy (JAG)
Time frame: one to five weeks after training course
Assessment of Competency in Endoscopy (ACE)
Time frame: one to five weeks after training course
mean self-assessment by Visual Analog Scale (VAS)
Time frame: one to five weeks after training course
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 28 Jun 2023.
- Background: PubMed 28927657Amiot A, Conroy G, Le Baleur Y, Winkler J, Palazzo M, Treton X. Endoscopic training: A nationwide survey of French fellows in gastroenterology. Clin Res Hepatol Gastroenterol. 2018 Apr;42(2):160-167. doi: 10.1016/j.clinre.2017.08.005. Epub 2017 Sep 18.
- Background: PubMed 25303910Jirapinyo P, Thompson CC. Current status of endoscopic simulation in gastroenterology fellowship training programs. Surg Endosc. 2015 Jul;29(7):1913-9. doi: 10.1007/s00464-014-3884-0. Epub 2014 Oct 11.
- Background: PubMed 22153875Ende A, Zopf Y, Konturek P, Naegel A, Hahn EG, Matthes K, Maiss J. Strategies for training in diagnostic upper endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2012 Feb;75(2):254-60. doi: 10.1016/j.gie.2011.07.063. Epub 2011 Dec 7.
- Background: PubMed 19889408Haycock A, Koch AD, Familiari P, van Delft F, Dekker E, Petruzziello L, Haringsma J, Thomas-Gibson S. Training and transfer of colonoscopy skills: a multinational, randomized, blinded, controlled trial of simulator versus bedside training. Gastrointest Endosc. 2010 Feb;71(2):298-307. doi: 10.1016/j.gie.2009.07.017. Epub 2009 Nov 3.
- Background: PubMed 15067632Sedlack RE, Kolars JC, Alexander JA. Computer simulation training enhances patient comfort during endoscopy. Clin Gastroenterol Hepatol. 2004 Apr;2(4):348-52. doi: 10.1016/s1542-3565(04)00067-9.
- Background: PubMed 18554236Shirai Y, Yoshida T, Shiraishi R, Okamoto T, Nakamura H, Harada T, Nishikawa J, Sakaida I. Prospective randomized study on the use of a computer-based endoscopic simulator for training in esophagogastroduodenoscopy. J Gastroenterol Hepatol. 2008 Jul;23(7 Pt 1):1046-50. doi: 10.1111/j.1440-1746.2008.05457.x. Epub 2008 Jun 28.
- Background: PubMed 16329017Ahlberg G, Hultcrantz R, Jaramillo E, Lindblom A, Arvidsson D. Virtual reality colonoscopy simulation: a compulsory practice for the future colonoscopist? Endoscopy. 2005 Dec;37(12):1198-204. doi: 10.1055/s-2005-921049.
- Background: PubMed 16923483Cohen J, Cohen SA, Vora KC, Xue X, Burdick JS, Bank S, Bini EJ, Bodenheimer H, Cerulli M, Gerdes H, Greenwald D, Gress F, Grosman I, Hawes R, Mullin G, Schnoll-Sussman F, Starpoli A, Stevens P, Tenner S, Villanueva G. Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy. Gastrointest Endosc. 2006 Sep;64(3):361-8. doi: 10.1016/j.gie.2005.11.062.
- Background: PubMed 15278044Di Giulio E, Fregonese D, Casetti T, Cestari R, Chilovi F, D'Ambra G, Di Matteo G, Ficano L, Delle Fave G. Training with a computer-based simulator achieves basic manual skills required for upper endoscopy: a randomized controlled trial. Gastrointest Endosc. 2004 Aug;60(2):196-200. doi: 10.1016/s0016-5107(04)01566-4.
- Background: PubMed 20972956Ferlitsch A, Schoefl R, Puespoek A, Miehsler W, Schoeniger-Hekele M, Hofer H, Gangl A, Homoncik M. Effect of virtual endoscopy simulator training on performance of upper gastrointestinal endoscopy in patients: a randomized controlled trial. Endoscopy. 2010 Dec;42(12):1049-56. doi: 10.1055/s-0030-1255818. Epub 2010 Oct 22.
- Background: PubMed 16942923Maiss J, Millermann L, Heinemann K, Naegel A, Peters A, Matthes K, Hahn EG, Hochberger J. The compactEASIE is a feasible training model for endoscopic novices: a prospective randomised trial. Dig Liver Dis. 2007 Jan;39(1):70-8; discussion 79-80. doi: 10.1016/j.dld.2006.07.007. Epub 2006 Aug 30.
- Background: PubMed 24729994McIntosh KS, Gregor JC, Khanna NV. Computer-based virtual reality colonoscopy simulation improves patient-based colonoscopy performance. Can J Gastroenterol Hepatol. 2014 Apr;28(4):203-6. doi: 10.1155/2014/804367.
- certification of endoscopic training by DGVSLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Thomas Rösch, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physicians Gastroscopy Training, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites 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 8 inclusion and 2 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) competence score competence score (time frame: one to five weeks after training course). The study lists 2 primary outcomes in all. 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 NCT04898803, which also lists 42 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 28 Jun 2023.