Scheduled Gastroscopy Under SedationEndoMouvNCT03458403
Endoscopist and Endoscope Motions During Digestive Endoscopy
A study testing Motions during gastroscopy in people with Scheduled Gastroscopy Under Sedation, run by IHU Strasbourg at 1 site in France.
Trial summary
The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scheduled Gastroscopy Under Sedation
- What is being tested?
- Motions during gastroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2018to 28 Jan 2022
- 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
- Patient over 18 years old
- Patient who are scheduled for a gastroscopy procedure under sedation
- Patient able to understand the study and provide written informed consent
- Patient affiliated to the French social security system.
Who cannot join
- Patient with an altered upper GI anatomy due to previous surgery
- Patient with a known anomaly of the upper GI anatomy
- Patient carrying an implantable medical device (pacemaker…)
- Patient with a condition preventing its participation to study procedures, according to investigator's judgment
- Pregnancy or breastfeeding
- Patient in custody
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, 67091
About this study
The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.
Read the detailed description
The increasing development of interventional digestive endoscopy raises the challenge to teach and learn complex endoscopic procedures. Nowadays experts are facing the challenge of explaining precisely an elaborate choreography of movements performed during the procedure, while novices are confronted with a broad range of hand, wrist and shoulder movements each resulting in different endoscope responses. The teaching strategy of endoscopy could benefit from a dedicated motion library that would associate the endoscopist's motion and the consequent endoscope response. A simplified endoscopic language made of individual motions could greatly shorten the learning curve.
The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.
- Conditions
- Scheduled Gastroscopy Under Sedation
- Being tested
- Motions during gastroscopy
- Keywords
- Digestive endoscopy, Tracking motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motions during gastroscopyProcedure or surgery
Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. The endoscope is removed halfway up the esophagus and inserted into the pylorus to the descending duodenum. The gesture is repeated three times.
| Study group | Role | What they receive |
|---|---|---|
| Motions during gastroscopy | Experimental | Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. Receives: Procedure: Motions during gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body motions recording
Body motions recording using the Xsens tracking device. The Xsens motion tracking system consists of 17 wireless motion sensors that are applied with straps to the endoscopist without hindering natural movements.
Measured: At time of endoscopy
Endoscope motions recording
Endoscope motions recording using the Aurora electromagnetic tracking system (NDI, Waterloo, Canada) inserted in the endoscope operating channel.
The Aurora electromagnetic tracking system is designed for tracking tip and orientation of rigid and flexible endoscopes. The system consists of an electromagnetic field generator and a probe carrying the captors.
Measured: At time of endoscopy
Endoscope wheels rotation recording
External video recording of the endoscope wheels rotation.
Measured: At time of endoscopy
Endoluminal images recording
Endoluminal images recording using the endoscopic camera.
Measured: At time of endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start29 Aug 2018
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scheduled Gastroscopy Under SedationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvana Perretta, MD, PhD, Principal investigator, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458403
- Sponsor's protocol ID
- 17-001
- Other IDs
- 2017-A01968-45
- Acronym
- EndoMouv
- Status last verified
- Feb 2023
- First submitted
- 2 Mar 2018
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kranzfelder M, Wilhelm D, Doundoulakis M, Schneider A, Bauer M, Reiser S, Meining A, Feussner H. A probe-based electromagnetic navigation system to integrate computed tomography during upper gastrointestinal endoscopy. Endoscopy. 2014 Apr;46(4):302-5. doi: 10.1055/s-0033-1358814. Epub 2013 Nov 19.
PubMed 24254384
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopist and Endoscope Motions During Digestive Endoscopy
- ClinicalTrials.gov ID
- NCT03458403
- Acronym / sponsor ID
- EndoMouv / 17-001
- Conditions
- Scheduled Gastroscopy Under Sedation
- Keywords
- Digestive endoscopy, Tracking motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 8 Mar 2018 (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 record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.
Detailed description
The increasing development of interventional digestive endoscopy raises the challenge to teach and learn complex endoscopic procedures. Nowadays experts are facing the challenge of explaining precisely an elaborate choreography of movements performed during the procedure, while novices are confronted with a broad range of hand, wrist and shoulder movements each resulting in different endoscope responses. The teaching strategy of endoscopy could benefit from a dedicated motion library that would associate the endoscopist's motion and the consequent endoscope response. A simplified endoscopic language made of individual motions could greatly shorten the learning curve.
The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motions during gastroscopy | Experimental | Procedure: Motions during gastroscopyRecording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years old
- Patient who are scheduled for a gastroscopy procedure under sedation
- Patient able to understand the study and provide written informed consent
- Patient affiliated to the French social security system.
Key exclusion criteria (7 listed)
- Patient with an altered upper GI anatomy due to previous surgery
- Patient with a known anomaly of the upper GI anatomy
- Patient carrying an implantable medical device (pacemaker…)
- Patient with a condition preventing its participation to study procedures, according to investigator's judgment
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Motions during gastroscopyRecording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. The endoscope is removed halfway up the esophagus and inserted into the pylorus to the descending duodenum. The gesture is repeated three times. | Procedure or surgery | Motions during gastroscopy |
Primary outcome
Body motions recording
Time frame: At time of endoscopy
Body motions recording using the Xsens tracking device. The Xsens motion tracking system consists of 17 wireless motion sensors that are applied with straps to the endoscopist without hindering natural movements.
Endoscope motions recording
Time frame: At time of endoscopy
Endoscope motions recording using the Aurora electromagnetic tracking system (NDI, Waterloo, Canada) inserted in the endoscope operating channel. The Aurora electromagnetic tracking system is designed for tracking tip and orientation of rigid and flexible endoscopes. The system consists of an electromagnetic field generator and a probe carrying the captors.
Endoscope wheels rotation recording
Time frame: At time of endoscopy
External video recording of the endoscope wheels rotation.
Endoluminal images recording
Time frame: At time of endoscopy
Endoluminal images recording using the endoscopic camera.
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 Feb 2023.
- Background: PubMed 24254384Kranzfelder M, Wilhelm D, Doundoulakis M, Schneider A, Bauer M, Reiser S, Meining A, Feussner H. A probe-based electromagnetic navigation system to integrate computed tomography during upper gastrointestinal endoscopy. Endoscopy. 2014 Apr;46(4):302-5. doi: 10.1055/s-0033-1358814. Epub 2013 Nov 19.
- 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.
Silvana Perretta, MD, PhD principal investigator
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motions during gastroscopy in people with Scheduled Gastroscopy Under Sedation, run by IHU Strasbourg at 1 site in France.
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 4 inclusion and 7 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 Feb 2023. 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 France. 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?
Body motions recording (time frame: At time of endoscopy). The study lists 4 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 NCT03458403, which also lists 1 linked publication.
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 Feb 2023.