Smart-gloves Hand Motion Tracking for Live Endoscopic Submucosal Dissection Training

NCT06683326 | Not Yet Recruiting

• 1 other identifier: EndoHandView
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Animal Model

Outcome Measures

Primary Outcomes (1)

• 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.

  During procedure

Secondary Outcomes (4)

• Rate of en-bloc resection

  During procedure

• Rate of R0 resection.

  During procedure

• Rate of perforation.

  During procedure

• Median satisfaction score.

  Immediately after procedure

Study Arms (2)

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.

Device: ROKOKO smart-glove

Control group

NO INTERVENTION

Control group, trainees viewing live broadcasting of the ESD screen, with live explanations by the expert

Interventions

ROKOKO smart-glove DEVICE

ESD expert hands and fingers motion broadcasted by the ROKOKO smart-glove to trainees

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ESD trainees with experience in EMR and difficult polypectomy

You may not qualify if:

• ESD trainees with previous significant experience in ESD on animal model
• ESD trainees with previous significant experience in ESD on patients

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead
• Hospices Civils de Lyon: collaborator

Related Publications (14)

• 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.

  PMID: 31470448 BACKGROUND

• Webster 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.

  PMID: 34111899 BACKGROUND

• Khashab 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.

  PMID: 36639318 BACKGROUND

• Ebigbo 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.

  PMID: 31828208 BACKGROUND

• Uchiyama 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.

  PMID: 37740173 BACKGROUND

• Shergill 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.

  PMID: 19111694 BACKGROUND

• Browne 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.

  PMID: 21880299 BACKGROUND

• Mohankumar 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.

  PMID: 24439784 BACKGROUND

• Holden 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.

  PMID: 29086234 BACKGROUND

• Caeiro-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.

  PMID: 33920101 BACKGROUND

• Brand 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.

  PMID: 32922274 BACKGROUND

• Jaskiewicz 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.

  PMID: 33235109 BACKGROUND

• Lee 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.

  PMID: 32176674 BACKGROUND

• Lacroute 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.

  PMID: 37156511 BACKGROUND

Related Links

• Lacey G, Ridgway P, Bhattacharya J. Measuring surgical knot tying with 3D vision and VR gloves. Semantic Scholar. 2019;
• https://www.rokoko.com/
• https://www.randomizer.org

MeSH Terms

Conditions

Disease Models, Animal

Condition Hierarchy (Ancestors)

Animal Diseases

Study Officials

• Mihai Ciocirlan, MD

  Carol Davila University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihai Ciocirlan, MD

CONTACT

+40722322625; ciocirlanm@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two randomized groups of trainees.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 12, 2024
• Study Start: May 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share