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Recruiting NCT07493863

Feasibility and Ergonomic Impact of A Virtual Reality Headset in Endoscopic Procedures

No phase Interventional Ergonomics Virtual Reality Headset Virtual Reality Endoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality headset, MYSELF checklist.
Who it may be relevant to
Registry conditions: Ergonomics, Virtual Reality Headset, Virtual Reality, Endoscopy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Virtual reality headset
    Use of the virtual reality headset during endoscopic procedures.
  • Other MYSELF checklist
    A preprocedural timeout to improve ergonomics.

Primary outcome measures

  • Risk Reduction of endoscopy related musculoskeletal injury by VRH as assessed by rapid entire body assessment (REBA) score. [Time frame: From the start until the end of an endoscopic procedure.]
Secondary outcome measures (3)
  • Endoscopist experience with VRH assess via subjective survey scored on a 5-point Likert scale. [Time frame: 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. [Time frame: 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. [Time frame: From the start until the end of an endoscopic procedure.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Cleveland Clinic Weston — Weston

Identifiers

NCT: NCT07493863 · 26-072

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗