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

NCT06683326 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-11-12

No results posted yet for this study

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

Interventions

DEVICE

ROKOKO smart-glove

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    collaborator OTHER

  • Carol Davila University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Mihai Ciocirlan, MD · Carol Davila University of Medicine and Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-05-31
Completion
2025-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683326 on ClinicalTrials.gov