Animal ModelEndoHandViewNCT06683326
Smart-gloves Hand Motion Tracking for Live Endoscopic Submucosal Dissection Training
A study testing ROKOKO smart-glove in people with Animal Model, run by Carol Davila University of Medicine and Pharmacy.
Trial summary
Learning endoscopic submucosal dissection (ESD) is undertaken by experienced endoscopists in endoscopic mucosal resection and management of complications. Understanding the theoretical approach of the procedure and the cutting line is a prerequisite of performing it. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Animal Model
- What is being tested?
- ROKOKO smart-glove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 May 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ESD trainees with experience in EMR and difficult polypectomy
Who cannot join
- ESD trainees with previous significant experience in ESD on animal model
- ESD trainees with previous significant experience in ESD on patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Smart-gloves Hand Motion Tracking for Live Endoscopic Submucosal Dissection Training: a Randomized, Comparative Study
Learning endoscopic submucosal dissection (ESD) is undertaken by experienced endoscopists in endoscopic mucosal resection and management of complications. Understanding the theoretical approach of the procedure and the cutting line is a prerequisite of performing it. The precise knife movements following the cutting line during incision, trimming and dissection takes time to master.
The European Society of Gastrointestinal Endoscopy (ESGE) recommends certain steps of the learning process: starting on animal models and further passing onto easier cases in patients, all these with expert supervision. Observation of experts directly or in live endoscopy meetings are recommended. Direct observation of the experts allow viewing and understanding the hand and finger movements during the specific ESD procedure phases (incision, trimming, dissection). Conversely, during live endoscopy meetings, one cannot see the hand and fingers movements of the operator. Using motion tracking smart-gloves, these fine movements may be visually broadcasted together with the endoscopic view during live meetings. There currently are no studies on motion tracking of hand and finger movements smart gloves in gastrointestinal endoscopy.
Read more
Broadcasting the ESD expert's hands and fingers movements using a motion tracking smart-glove during a live endoscopy event will increase the trainees ESD procedure speed. Concomitantly seeing the endoscopic view and the hand and fingers view, the trainee will establish a relationship between the hand and fingers movement and the effect on the dissected tissue. A faster practical "how to do it" formula will hopefully be acquired by the trainee.
Additional benefits are expected, as a faster trainee learning curve will diminish the carbon footprint of the endoscopic training process.
A prospective randomized study will be implemented to test the research hypothesis. Trainees will be divided in two groups, depending on their view during live ESD procedures performed by the experts: the study group [endoscopic view + hand motion view] versus the control group [only endoscopic view]. The experts endoscopists will demonstrate ESD procedures on an animal model. Afterwards, the trainee will perform, under supervision, an ESD procedure on the same animal model. Several parameters will be noted: speed of the procedure, the en-bloc or piece-meal resection, the R0 resection, presence of complications (perforation) and the satisfaction score of the trainee on a numerical visual scale.
Read the detailed description
Rationale.
ESD is difficult to learn. Learning is usually undertaken by already trained endoscopists, with experience in difficult polypectomy. Except marking, hemostasis and clip closure, the very precise distinctive ESD movements - incision, trimming and submucosal dissection are new hand gestures for someone starting this path.
After studying ESD strategy and tactics - where to start and continue ("when to cut") and what part of the lesion ("what to cut"), one needs to understand the cutting line ("where to cut"). This cutting line is to be followed precisely, in an extremely accurate manner during incision, trimming and actual submucosal dissection. Any millimetric deviation from this ideal line may and will result in lengthening or procedure failure in best case scenario and in iterative bleedings and perforation in worst case scenarios.
The ESGE learning curricula recommends that a proficient in EMR endoscopist should start supervised ESD training. Firstly, in animal models (at least 20 procedures with no perforation in the last 10 training cases and 80% R0 rate) and afterwards, supervised simpler cases on real patients [1]. Observing at least 20 ESD procedures performed by experts in tertiary referral centers as well as live conferences and meetings are encouraged.
Based on available evidence, current ESGE and ASGE guidelines for best practices of live endoscopy events do not find an increased harm for patients [2,3]. Moreover, in a study comparing the outcomes of ESD in a live event versus standard of care, the outcome numbers were non-inferior, and some were even slightly non significantly superior (en-bloc rates 100% vs. 87%, curative rates 84% vs. 71%, complication rates 5% vs. 13%, 5-year survival rates 70% vs. 65%) [4]. Nevertheless, both guidelines state that there is no current data supporting that attending live endoscopy events will improve ESD outcome in trainees.
Unfortunately, observing an ESD procedure during a live endoscopy event is not the same experience as being in the same room as the operator. The endoscopic screen and the verbal explanations may be there. Still, the exact hand movements by the operator will be missed. Viewing the expert's hands and fingers movements during such a complex procedure is of utmost importance.
A recent 2023 study evaluated the benefit of a live broadcasting GoPro action camera attached to the endoscopist head [5]. The supplementary doctor's eye-view video increased the trainees interest and understanding of the procedure. However, as the endoscopist gaze will be pointed to the endoscopy screen most of the time, the hand and finger gestures will not be GoPro broadcasted and live seen by trainees.
How to observe and analyze hand and finger movements during and ESD procedure? Hand gestures during colonoscopy were quantified in different studies assessing pressure and force by tactile pads, electrogoniometers, magnetic trackers and electromagnetic motion sensors [6-9]. These studies aimed to assess muscle strain and postures during colonoscopy and their different patterns in expert and novice operators.
Smart-gloves were proposed to measure kinesthetic and tactile feed-back, but also hand and finger pose and motion tracking [10]. Medical studies so far used hand motion tracking smart-gloves to quantify and/or monitor concomitant brain activation, hand joints stress, chest compressions during CPR, drawing coordination skills, surgical knot tying and post stroke hand grip rehabilitation [11-16]. Tracking hand and fingers motion during ESD may be possible as well using available commercial smart-gloves.
The ROKOKO smart-gloves use electro-magnetic field (EMF) sensors to capture precise hand and finger movements. It instantly broadcasts with 100 frame per second rate, without lag or latency. It may be integrated with all major 3D animation tools and game engines and is currently used, among others, by Walt Disney Studios, Universal Studios, Sony, Netflix, HBO, Electronic Arts, [17].
Study hypothesis.
Broadcasting the ESD expert's hands and fingers movements using a motion tracking smart-glove during a live endoscopy event will increase the trainees speed of the ESD procedure. It will increase the rate of en-bloc resection, the rates of curative resection and will decrease the rate of complications. While at distance, the trainee will be able to concomitantly see the two screens - the [endoscopic view] and the [hand and fingers view]. A relationship between the hand and fingers motions and the transmitted effect onto knife tip and further onto the lesion tissue will be better understood. A practical "how to do it" knowledge will be hopefully acquired by the trainee, faster.
- Conditions
- Animal Model
- Being tested
- ROKOKO smart-glove
- Medical subject headings
- Disease Models, Animal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROKOKO smart-gloveDevice
ESD expert hands and fingers motion broadcasted by the ROKOKO smart-glove to trainees
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Trainees viewing live broadcasting of the ESD screen, with live explanations by the expert and simultaneous viewing of the expert hands and fingers motion broadcasted by the ROKOKO smart-glove. Receives: Device: ROKOKO smart-glove |
| Control group | No intervention | Control group, trainees viewing live broadcasting of the ESD screen, with live explanations by the expert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean speed of the procedure
Measured in mm2/minute. Equal to the sum of the procedure speed for each procedure divided by the number of procedures for each study group.
Measured: During procedure
Secondary outcomes (4)
Rate of en-bloc resection
Defined as lesions resected in one piece. Equal to the number of en-bloc resected lesions divided by the number of resected lesions for each study group.
Measured: During procedure
Rate of R0 resection.
Defined as lesions resected in one piece containing all peripheral marking dots. Equal to the number of R0 resections divided by the number of resected lesions in each group.
Measured: During procedure
Rate of perforation.
Equal to the number of perforations divided by the number of resected lesions in each group.
Measured: During procedure
Median satisfaction score.
Measured on a visual analogue scale (0 to 10, 0 equal unsatisfied, 10 equal maximum satisfaction). Equal to the median satisfaction value of trainees within each study group.
Measured: Immediately after procedure
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 start1 May 2025 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Animal ModelStudies 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
- Two randomized groups of trainees.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Principal investigator, Mihai Ciocirlan, Carol Davila University of Medicine and Pharmacy
- Investigators
- Mihai Ciocirlan, MD, Principal investigator, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683326
- Sponsor's protocol ID
- EndoHandView
- Acronym
- EndoHandView
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pimentel-Nunes P, Pioche M, Albeniz E, Berr F, Deprez P, Ebigbo A, Dewint P, Haji A, Panarese A, Weusten BLAM, Dekker E, East JE, Sanders DS, Johnson G, Arvanitakis M, Ponchon T, Dinis-Ribeiro M, Bisschops R. Curriculum for endoscopic submucosal dissection training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2019 Oct;51(10):980-992. doi: 10.1055/a-0996-0912. Epub 2019 Aug 30.
PubMed 31470448Webster GJ, El Menabawey T, Arvanitakis M, Hassan C, van Hooft JE, Messmann H, Dinis-Ribeiro M. Live endoscopy events (LEEs): European Society of Gastrointestinal Endoscopy Position Statement - Update 2021. Endoscopy. 2021 Aug;53(8):842-849. doi: 10.1055/a-1511-1657. Epub 2021 Jun 10.
PubMed 34111899Khashab MA, Muthusamy VR, Akshintala VS, Kothari S, Sethi A, Rastogi A, Palmisano DJ Jr, Zhang LY, Hess MR, Rashba K, Gupta N, Wani S, Komanduri S. Best live endoscopy practices: an ASGE white paper. Gastrointest Endosc. 2023 Mar;97(3):383-393.e3. doi: 10.1016/j.gie.2022.09.012. Epub 2023 Jan 11. No abstract available.
PubMed 36639318Ebigbo A, Freund S, Probst A, Rommele C, Golder SK, Frauenschuh J, Marienhagen J, Messmann H. Outcomes of endoscopic submucosal dissection (ESD) during live endoscopy events (LEE) - a 13-year follow-up. Endosc Int Open. 2019 Dec;7(12):E1723-E1728. doi: 10.1055/a-1035-9240. Epub 2019 Dec 10.
PubMed 31828208Uchiyama A, Yamashina S, Sato T, Sakuma S, Tomiki Y, Isayama H, Nagahara A, Ikejima K. Benefit of an action camera in endoscopy education for medical students under COVID-19. BMC Med Educ. 2023 Sep 22;23(1):693. doi: 10.1186/s12909-023-04702-6.
PubMed 37740173Shergill AK, Asundi KR, Barr A, Shah JN, Ryan JC, McQuaid KR, Rempel D. Pinch force and forearm-muscle load during routine colonoscopy: a pilot study. Gastrointest Endosc. 2009 Jan;69(1):142-6. doi: 10.1016/j.gie.2008.09.030.
PubMed 19111694Browne A, O'Sullivan L. A medical hand tool physical interaction evaluation approach for prototype testing using patient care simulators. Appl Ergon. 2012 May;43(3):493-500. doi: 10.1016/j.apergo.2011.08.002. Epub 2011 Aug 30.
PubMed 21880299Mohankumar D, Garner H, Ruff K, Ramirez FC, Fleischer D, Wu Q, Santello M. Characterization of right wrist posture during simulated colonoscopy: an application of kinematic analysis to the study of endoscopic maneuvers. Gastrointest Endosc. 2014 Mar;79(3):480-9. doi: 10.1016/j.gie.2013.11.023. Epub 2014 Jan 17.
PubMed 24439784Holden MS, Wang CN, MacNeil K, Church B, Hookey L, Fichtinger G, Ungi T. Objective assessment of colonoscope manipulation skills in colonoscopy training. Int J Comput Assist Radiol Surg. 2018 Jan;13(1):105-114. doi: 10.1007/s11548-017-1676-4. Epub 2017 Oct 30.
PubMed 29086234Caeiro-Rodriguez M, Otero-Gonzalez I, Mikic-Fonte FA, Llamas-Nistal M. A Systematic Review of Commercial Smart Gloves: Current Status and Applications. Sensors (Basel). 2021 Apr 10;21(8):2667. doi: 10.3390/s21082667.
PubMed 33920101Brand J, Piccirelli M, Hepp-Reymond MC, Eng K, Michels L. Brain Activation During Visually Guided Finger Movements. Front Hum Neurosci. 2020 Aug 14;14:309. doi: 10.3389/fnhum.2020.00309. eCollection 2020.
PubMed 32922274Jaskiewicz F, Kowalewski D, Starosta K, Cierniak M, Timler D. Chest compressions quality during sudden cardiac arrest scenario performed in virtual reality: A crossover study in a training environment. Medicine (Baltimore). 2020 Nov 25;99(48):e23374. doi: 10.1097/MD.0000000000023374.
PubMed 33235109Lee HS, Lim JH, Jeon BH, Song CS. Non-immersive Virtual Reality Rehabilitation Applied to a Task-oriented Approach for Stroke Patients: A Randomized Controlled Trial. Restor Neurol Neurosci. 2020;38(2):165-172. doi: 10.3233/RNN-190975.
PubMed 32176674Lacroute J, Marcantoni J, Petitot S, Weber J, Levy P, Dirrenberger B, Tchoumak I, Baron M, Gibert S, Marguerite S, Huppertz J, Gronier O, Derlon A. The carbon footprint of ambulatory gastrointestinal endoscopy. Endoscopy. 2023 Oct;55(10):918-926. doi: 10.1055/a-2088-4062. Epub 2023 May 8.
PubMed 37156511
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
- Smart-gloves Hand Motion Tracking for Live Endoscopic Submucosal Dissection Training: a Randomized, Comparative Study
- ClinicalTrials.gov ID
- NCT06683326
- Acronym / sponsor ID
- EndoHandView / EndoHandView
- Conditions
- Animal Model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (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.
Learning endoscopic submucosal dissection (ESD) is undertaken by experienced endoscopists in endoscopic mucosal resection and management of complications. Understanding the theoretical approach of the procedure and the cutting line is a prerequisite of performing it. The precise knife movements following the cutting line during incision, trimming and dissection takes time to master.
The European Society of Gastrointestinal Endoscopy (ESGE) recommends certain steps of the learning process: starting on animal models and further passing onto easier cases in patients, all these with expert supervision. Observation of experts directly or in live endoscopy meetings are recommended. Direct observation of the experts allow viewing and understanding the hand and finger movements during the specific ESD procedure phases (incision, trimming, dissection). Conversely, during live endoscopy meetings, one cannot see the hand and fingers movements of the operator. Using motion tracking smart-gloves, these fine movements may be visually broadcasted together with the endoscopic view during live meetings. There currently are no studies on motion tracking of hand and finger movements smart gloves in gastrointestinal endoscopy.
Broadcasting the ESD expert's hands and fingers movements using a motion tracking smart-glove during a live endoscopy event will increase the trainees ESD procedure speed. Concomitantly seeing the endoscopic view and the hand and fingers view, the trainee will establish a relationship between the hand and fingers movement and the effect on the dissected tissue. A faster practical "how to do it" formula will hopefully be acquired by the trainee.
Additional benefits are expected, as a faster trainee learning curve will diminish the carbon footprint of the endoscopic training process.
A prospective randomized study will be implemented to test the research hypothesis. Trainees will be divided in two groups, depending on their view during live ESD procedures performed by the experts: the study group [endoscopic view + hand motion view] versus the control group [only endoscopic view]. The experts endoscopists will demonstrate ESD procedures on an animal model. Afterwards, the trainee will perform, under supervision, an ESD procedure on the same animal model. Several parameters will be noted: speed of the procedure, the en-bloc or piece-meal resection, the R0 resection, presence of complications (perforation) and the satisfaction score of the trainee on a numerical visual scale.
Detailed description
Rationale.
ESD is difficult to learn. Learning is usually undertaken by already trained endoscopists, with experience in difficult polypectomy. Except marking, hemostasis and clip closure, the very precise distinctive ESD movements - incision, trimming and submucosal dissection are new hand gestures for someone starting this path.
After studying ESD strategy and tactics - where to start and continue ("when to cut") and what part of the lesion ("what to cut"), one needs to understand the cutting line ("where to cut"). This cutting line is to be followed precisely, in an extremely accurate manner during incision, trimming and actual submucosal dissection. Any millimetric deviation from this ideal line may and will result in lengthening or procedure failure in best case scenario and in iterative bleedings and perforation in worst case scenarios.
The ESGE learning curricula recommends that a proficient in EMR endoscopist should start supervised ESD training. Firstly, in animal models (at least 20 procedures with no perforation in the last 10 training cases and 80% R0 rate) and afterwards, supervised simpler cases on real patients [1]. Observing at least 20 ESD procedures performed by experts in tertiary referral centers as well as live conferences and meetings are encouraged.
Based on available evidence, current ESGE and ASGE guidelines for best practices of live endoscopy events do not find an increased harm for patients [2,3]. Moreover, in a study comparing the outcomes of ESD in a live event versus standard of care, the outcome numbers were non-inferior, and some were even slightly non significantly superior (en-bloc rates 100% vs. 87%, curative rates 84% vs. 71%, complication rates 5% vs. 13%, 5-year survival rates 70% vs. 65%) [4]. Nevertheless, both guidelines state that there is no current data supporting that attending live endoscopy events will improve ESD outcome in trainees.
Unfortunately, observing an ESD procedure during a live endoscopy event is not the same experience as being in the same room as the operator. The endoscopic screen and the verbal explanations may be there. Still, the exact hand movements by the operator will be missed. Viewing the expert's hands and fingers movements during such a complex procedure is of utmost importance.
A recent 2023 study evaluated the benefit of a live broadcasting GoPro action camera attached to the endoscopist head [5]. The supplementary doctor's eye-view video increased the trainees interest and understanding of the procedure. However, as the endoscopist gaze will be pointed to the endoscopy screen most of the time, the hand and finger gestures will not be GoPro broadcasted and live seen by trainees.
How to observe and analyze hand and finger movements during and ESD procedure? Hand gestures during colonoscopy were quantified in different studies assessing pressure and force by tactile pads, electrogoniometers, magnetic trackers and electromagnetic motion sensors [6-9]. These studies aimed to assess muscle strain and postures during colonoscopy and their different patterns in expert and novice operators.
Smart-gloves were proposed to measure kinesthetic and tactile feed-back, but also hand and finger pose and motion tracking [10]. Medical studies so far used hand motion tracking smart-gloves to quantify and/or monitor concomitant brain activation, hand joints stress, chest compressions during CPR, drawing coordination skills, surgical knot tying and post stroke hand grip rehabilitation [11-16]. Tracking hand and fingers motion during ESD may be possible as well using available commercial smart-gloves.
The ROKOKO smart-gloves use electro-magnetic field (EMF) sensors to capture precise hand and finger movements. It instantly broadcasts with 100 frame per second rate, without lag or latency. It may be integrated with all major 3D animation tools and game engines and is currently used, among others, by Walt Disney Studios, Universal Studios, Sony, Netflix, HBO, Electronic Arts, [17].
Study hypothesis.
Broadcasting the ESD expert's hands and fingers movements using a motion tracking smart-glove during a live endoscopy event will increase the trainees speed of the ESD procedure. It will increase the rate of en-bloc resection, the rates of curative resection and will decrease the rate of complications. While at distance, the trainee will be able to concomitantly see the two screens - the [endoscopic view] and the [hand and fingers view]. A relationship between the hand and fingers motions and the transmitted effect onto knife tip and further onto the lesion tissue will be better understood. A practical "how to do it" knowledge will be hopefully acquired by the trainee, faster.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two randomized groups of trainees.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: ROKOKO smart-gloveTrainees viewing live broadcasting of the ESD screen, with live explanations by the expert and simultaneous viewing of the expert hands and fingers motion broadcasted by the ROKOKO smart-glove. |
| Control group | No intervention | –Control group, trainees viewing live broadcasting of the ESD screen, with live explanations by the expert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ESD trainees with experience in EMR and difficult polypectomy
Key exclusion criteria (2 listed)
- ESD trainees with previous significant experience in ESD on animal model
- ESD trainees with previous significant experience in ESD on patients
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 |
|---|---|---|
| ROKOKO smart-gloveESD expert hands and fingers motion broadcasted by the ROKOKO smart-glove to trainees | Device | Study group |
Primary outcome
Mean speed of the procedure
Time frame: During procedure
Measured in mm2/minute. Equal to the sum of the procedure speed for each procedure divided by the number of procedures for each study group.
4 secondary outcomes
Rate of en-bloc resection
Time frame: During procedure
Rate of R0 resection.
Time frame: During procedure
Rate of perforation.
Time frame: During procedure
Median satisfaction score.
Time frame: Immediately after procedure
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 31470448Pimentel-Nunes P, Pioche M, Albeniz E, Berr F, Deprez P, Ebigbo A, Dewint P, Haji A, Panarese A, Weusten BLAM, Dekker E, East JE, Sanders DS, Johnson G, Arvanitakis M, Ponchon T, Dinis-Ribeiro M, Bisschops R. Curriculum for endoscopic submucosal dissection training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2019 Oct;51(10):980-992. doi: 10.1055/a-0996-0912. Epub 2019 Aug 30.
- Background: PubMed 34111899Webster GJ, El Menabawey T, Arvanitakis M, Hassan C, van Hooft JE, Messmann H, Dinis-Ribeiro M. Live endoscopy events (LEEs): European Society of Gastrointestinal Endoscopy Position Statement - Update 2021. Endoscopy. 2021 Aug;53(8):842-849. doi: 10.1055/a-1511-1657. Epub 2021 Jun 10.
- Background: PubMed 36639318Khashab MA, Muthusamy VR, Akshintala VS, Kothari S, Sethi A, Rastogi A, Palmisano DJ Jr, Zhang LY, Hess MR, Rashba K, Gupta N, Wani S, Komanduri S. Best live endoscopy practices: an ASGE white paper. Gastrointest Endosc. 2023 Mar;97(3):383-393.e3. doi: 10.1016/j.gie.2022.09.012. Epub 2023 Jan 11. No abstract available.
- Background: PubMed 31828208Ebigbo A, Freund S, Probst A, Rommele C, Golder SK, Frauenschuh J, Marienhagen J, Messmann H. Outcomes of endoscopic submucosal dissection (ESD) during live endoscopy events (LEE) - a 13-year follow-up. Endosc Int Open. 2019 Dec;7(12):E1723-E1728. doi: 10.1055/a-1035-9240. Epub 2019 Dec 10.
- Background: PubMed 37740173Uchiyama A, Yamashina S, Sato T, Sakuma S, Tomiki Y, Isayama H, Nagahara A, Ikejima K. Benefit of an action camera in endoscopy education for medical students under COVID-19. BMC Med Educ. 2023 Sep 22;23(1):693. doi: 10.1186/s12909-023-04702-6.
- Background: PubMed 19111694Shergill AK, Asundi KR, Barr A, Shah JN, Ryan JC, McQuaid KR, Rempel D. Pinch force and forearm-muscle load during routine colonoscopy: a pilot study. Gastrointest Endosc. 2009 Jan;69(1):142-6. doi: 10.1016/j.gie.2008.09.030.
- Background: PubMed 21880299Browne A, O'Sullivan L. A medical hand tool physical interaction evaluation approach for prototype testing using patient care simulators. Appl Ergon. 2012 May;43(3):493-500. doi: 10.1016/j.apergo.2011.08.002. Epub 2011 Aug 30.
- Background: PubMed 24439784Mohankumar D, Garner H, Ruff K, Ramirez FC, Fleischer D, Wu Q, Santello M. Characterization of right wrist posture during simulated colonoscopy: an application of kinematic analysis to the study of endoscopic maneuvers. Gastrointest Endosc. 2014 Mar;79(3):480-9. doi: 10.1016/j.gie.2013.11.023. Epub 2014 Jan 17.
- Background: PubMed 29086234Holden MS, Wang CN, MacNeil K, Church B, Hookey L, Fichtinger G, Ungi T. Objective assessment of colonoscope manipulation skills in colonoscopy training. Int J Comput Assist Radiol Surg. 2018 Jan;13(1):105-114. doi: 10.1007/s11548-017-1676-4. Epub 2017 Oct 30.
- Background: PubMed 33920101Caeiro-Rodriguez M, Otero-Gonzalez I, Mikic-Fonte FA, Llamas-Nistal M. A Systematic Review of Commercial Smart Gloves: Current Status and Applications. Sensors (Basel). 2021 Apr 10;21(8):2667. doi: 10.3390/s21082667.
- Background: PubMed 32922274Brand J, Piccirelli M, Hepp-Reymond MC, Eng K, Michels L. Brain Activation During Visually Guided Finger Movements. Front Hum Neurosci. 2020 Aug 14;14:309. doi: 10.3389/fnhum.2020.00309. eCollection 2020.
- Background: PubMed 33235109Jaskiewicz F, Kowalewski D, Starosta K, Cierniak M, Timler D. Chest compressions quality during sudden cardiac arrest scenario performed in virtual reality: A crossover study in a training environment. Medicine (Baltimore). 2020 Nov 25;99(48):e23374. doi: 10.1097/MD.0000000000023374.
- Lacey G, Ridgway P, Bhattacharya J. Measuring surgical knot tying with 3D vision and VR gloves. Semantic Scholar. 2019;Link provided by the sponsor.
- https://www.rokoko.com/Link provided by the sponsor.
- https://www.randomizer.orgLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Mental Well-being, Muscle Strengh
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.
Mihai Ciocirlan, MD principal investigator
Carol Davila University of Medicine and Pharmacy
Questions about this trial
What is this clinical trial studying?
A study testing ROKOKO smart-glove in people with Animal Model, run by Carol Davila University of Medicine and Pharmacy.
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 1 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: 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.
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 Mihai Ciocirlan, MD (+40722322625, ciocirlanm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean speed of the procedure (time frame: During procedure). 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 NCT06683326, which also lists 14 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.