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Lo studio clinico NCT07493863 per Ergonomics, Virtual Reality Headset, Realtà virtuale, Endoscopia è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Feasibility and Ergonomic Impact of A Virtual Reality Headset in Endoscopic Procedures 140 Virtuale
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La sperimentazione clinica NCT07493863 è uno studio interventistico per Ergonomics, Virtual Reality Headset, Realtà virtuale, Endoscopia, attualmente in arruolamento. Avviato il 10 marzo 2026, prevede di arruolare 140 partecipanti. Sotto la guida di The Cleveland Clinic, dovrebbe concludersi entro il 1 dicembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 marzo 2026.
Sommario breve
The purpose of this study is to assess the feasibility of using a virtual reality headset (VRH) during endoscopy and its impact on the endoscopist ergonomics. We will use the Apple Vision Pro during approximately 140 endoscopic procedures during which ergonomics will be assessed.
Titolo ufficiale
Feasibility and Ergonomic Impact of A Virtual Reality Headset in Endoscopic Procedures
Patologie
ErgonomicsVirtual Reality HeadsetRealtà virtualeEndoscopiaAltri ID dello studio
- 26-072
Numero NCT
Data di inizio (effettiva)
2026-03-10
Ultimo aggiornamento pubblicato
2026-03-25
Data di completamento (stimata)
2026-12
Arruolamento (previsto)
140
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
ergonomics
virtual reality
virtual reality headset
endoscopy
virtual reality
virtual reality headset
endoscopy
Scopo principale
Prevenzione
Allocazione
Non randomizzato
Modello di intervento
Sequenziale
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivoNonVRH Endoscopic procedure without virtual reality headset (VRH) | MYSELF checklist A preprocedural timeout to improve ergonomics. |
Comparatore attivoVRH Endoscopic procedure completed with virtual reality headset (VRH) | Visore di realtà virtuale Use of the virtual reality headset during endoscopic procedures. MYSELF checklist A preprocedural timeout to improve ergonomics. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Risk Reduction of endoscopy related musculoskeletal injury by VRH as assessed by rapid entire body assessment (REBA) score. | The REBA score is an ergonomic assessment tool used to identify potential risks of musculoskeletal disorders in the workplace by evaluating posture and movements. The score ranges from 0-15 with 0 being the lowest risk and 15 being the highest risk. A two point decrease pre-intervention will be considered significant. | From the start until the end of an endoscopic procedure. |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Endoscopist experience with VRH assess via subjective survey scored on a 5-point Likert scale. | The survey includes six questions on ergonomics, technical feasibility, visual clarity, workflow, mental demands, and overall experience. Each question is scored 1-5 with the higher score being outcome. | From the start until the end of an endoscopic procedure. |
Risk reduction of endoscopic related musculoskeletal injury in specific subgroups (colonoscopy, EUS, ERCP) by VRH as assessed by rapid entire body assessment (REBA) score. | The REBA score is an ergonomic assessment tool used to identify potential risks of musculoskeletal disorders in the workplace by evaluating posture and movements. The score ranges from 0-15 with 0 being the lowest risk and 15 being the highest risk. A two point decrease pre-intervention will be considered significant. | From the start until the end of an endoscopic procedure. |
risk reduction of endoscopy related musculoskeletal injury due to pre-procedural checklist as assessed by rapid entire body assessment (REBA) score. | The REBA score is an ergonomic assessment tool used to identify potential risks of musculoskeletal disorders in the workplace by evaluating posture and movements. The score ranges from 0-15 with 0 being the lowest risk and 15 being the highest risk. A two point decrease pre-intervention will be considered significant. | From the start until the end of an endoscopic procedure. |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Sessi idonei
Tutti
Accetta volontari sani
Sì
- Endoscopist: endoscopist at Cleveland Clinic Weston who consent to participate in the study and are performing either colonoscopy, EUS, or ERCP.
- Patient: patient undergoing colonoscopy, EUS, or ERCP
- Exclude the following procedures: Device-assisted colonoscopy (e.g.- double balloon, pathfinder, etc)
- ERCP in native papilla
- Cholangioscopy
- Therapeutic EUS procedures (FNA/FNB, Stent Placement)
- Planned Mucosal Resection of Polyps > 20 mm
- Inpatient procedures
- Aborted procedures
Parte responsabile dello studio
Shah,Tilak, Investigatore principale, Medical Director, National Pancreas Center of Excellence, Advanced Therapeutic Endoscopy, The Cleveland Clinic
Nessun dato di contatto
1 Centri dello studio in 1 paesi
Florida
Cleveland Clinic Weston, Weston, Florida, 33331, United States
Tilak Shah, MD, Contatto, 877.463.2010, [email protected]
In arruolamento