- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07493863
Feasibility and Ergonomic Impact of A Virtual Reality Headset in Endoscopic Procedures
March 20, 2026 updated by: Shah,Tilak, The Cleveland Clinic
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Weston, Florida, United States, 33331
- Recruiting
- Cleveland Clinic Weston
-
Contact:
- Tilak Shah, MD
- Phone Number: 877.463.2010
- Email: SHAHT3@ccf.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: NonVRH
Endoscopic procedure without virtual reality headset (VRH)
|
A preprocedural timeout to improve ergonomics.
|
|
Active Comparator: VRH
Endoscopic procedure completed with virtual reality headset (VRH)
|
A preprocedural timeout to improve ergonomics.
Use of the virtual reality headset during endoscopic procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
Time Frame: From the start until the end of an endoscopic procedure.
|
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.
Time Frame: From the start until the end of an endoscopic procedure.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 11, 2026
First Submitted That Met QC Criteria
March 20, 2026
First Posted (Actual)
March 25, 2026
Study Record Updates
Last Update Posted (Actual)
March 25, 2026
Last Update Submitted That Met QC Criteria
March 20, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 26-072
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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