NCT07493863

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 10, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 11, 2026

Last Update Submit

March 20, 2026

Conditions

Keywords

ergonomicsvirtual realityvirtual reality headsetendoscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • Endoscopist experience with VRH assess via subjective survey scored on a 5-point Likert scale.

    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.

    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.

    From the start until the end of an endoscopic procedure.

Study Arms (2)

NonVRH

ACTIVE COMPARATOR

Endoscopic procedure without virtual reality headset (VRH)

Other: MYSELF checklist

VRH

ACTIVE COMPARATOR

Endoscopic procedure completed with virtual reality headset (VRH)

Device: Virtual reality headsetOther: MYSELF checklist

Interventions

Use of the virtual reality headset during endoscopic procedures.

VRH

A preprocedural timeout to improve ergonomics.

NonVRHVRH

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Weston

Weston, Florida, 33331, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, National Pancreas Center of Excellence, Advanced Therapeutic Endoscopy

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 25, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations