Intestinal DiseaseScopeGuideNCT04263818
Endoscopist and Endoscope Motions During Colonoscopy
A study testing Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for in people with Intestinal Disease and Colonic Diseases, 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 during colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Disease, Colonic Diseases
- What is being tested?
- Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2020to 5 Jul 2021
- 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 male or female
- Patient over 18 years old
- Patient who are scheduled for a colonoscopy 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 unable to provide a written informed consent
- Patient with an altered colonic anatomy due to previous surgery
- Patient with a known anomaly of the colon
- 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, NHC
Strasbourg, 67000
About this study
Official title: Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie
The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.
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 during colonoscopy.
- Conditions
- Intestinal Disease, Colonic Diseases
- Being tested
- Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for
- Keywords
- colonoscopy, tracking motion
- Medical subject headings
- Intestinal Diseases, Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came forProcedure or surgery
Carrying out the endoscopic procedure planned for the patient with the dedicated colonoscope which has magnetic coils over the entire length of the insertion tube. These magnetic coils generate a pulsed magnetic field at low frequency. These pulses are transmitted to an external receiver, refreshed at 15 images per second, then relayed to the processor to generate a 3D representation of the colonoscope next to it of the endoscopic image. There is no additional risk to the patient compared to current practice.
Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for.
| Study group | Role | What they receive |
|---|---|---|
| Motions during colonoscopy | Experimental | Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for Receives: Procedure: Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for |
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 colonoscopy
Endoscope motions recording
Endoscope motions recording using the ScopeGuide tracking system. Real-time visualization of the ScopeGuide system is possible thanks to integrated electromagnetic coils and an external sensor that generate a 3D representation of the colonoscope next to the endoscopic image.
Measured: At time of colonoscopy
Endoscope wheels rotation recording
External video recording of the endoscope wheels rotation
Measured: At time of colonoscopy
Endoluminal images recording
Endoluminal images recording using the endoscopic camera.
Measured: At time of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start5 Jun 2020
- Primary completion5 Jun 2021
- Study completion5 Jul 2021
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 Intestinal DiseaseStudies 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
- 12 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, NHC, Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263818
- Sponsor's protocol ID
- 19-003
- Acronym
- ScopeGuide
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2020
- 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
Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16.
PubMed 21409379
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
- Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie
- ClinicalTrials.gov ID
- NCT04263818
- Acronym / sponsor ID
- ScopeGuide / 19-003
- Conditions
- Intestinal Disease, Colonic Diseases
- Keywords
- colonoscopy, tracking motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 11 Feb 2020 (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 during colonoscopy.
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 during colonoscopy.
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 colonoscopy | Experimental | Procedure: Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came forRecording 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 (5 listed)
- Patient male or female
- Patient over 18 years old
- Patient who are scheduled for a colonoscopy 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 (8 listed)
- Patient unable to provide a written informed consent
- Patient with an altered colonic anatomy due to previous surgery
- Patient with a known anomaly of the colon
- Patient carrying an implantable medical device (pacemaker…)
- Patient with a condition preventing its participation to study procedures, according to investigator's judgment
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 |
|---|---|---|
| Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came forCarrying out the endoscopic procedure planned for the patient with the dedicated colonoscope which has magnetic coils over the entire length of the insertion tube. These magnetic coils generate a pulsed magnetic field at low frequency. These pulses are transmitted to an external receiver, refreshed at 15 images per second, then relayed to the processor to generate a 3D representation of the colonoscope next to it of the endoscopic image. There is no additional risk to the patient compared to current practice. Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. | Procedure or surgery | Motions during colonoscopy |
Primary outcome
Body motions recording
Time frame: At time of colonoscopy
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 colonoscopy
Endoscope motions recording using the ScopeGuide tracking system. Real-time visualization of the ScopeGuide system is possible thanks to integrated electromagnetic coils and an external sensor that generate a 3D representation of the colonoscope next to the endoscopic image.
Endoscope wheels rotation recording
Time frame: At time of colonoscopy
External video recording of the endoscope wheels rotation
Endoluminal images recording
Time frame: At time of colonoscopy
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 21409379Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16.
- Individual participant dataSharing planned: No
Related trials for Intestinal Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
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, NHC, 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 Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for in people with Intestinal Disease and Colonic Diseases, 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 5 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 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 colonoscopy). 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 NCT04263818, 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.