Impact of Surgical Theater's Patient Engagement

NCT ID: NCT05334212

Last Updated: 2023-02-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-02-02

Brief Summary

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To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.

Detailed Description

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Surgical Theater is a company that has developed a platform which can be used to describe and explain spinal surgery to patient before they undergo the procedure. The platform specifically implements data from the patient's own MRI and CT scans, creating a 3d reconstruction that can be seen through a virtual reality lens. This technology was developed to help clarify any concerns patient's may have before surgery, and help them better appreciate what will occur in the OR.

Surgical theater has FDA clearance for patient interaction and engagement. Our study is to take surgical theater into our clinics and, after a patient is defined as a surgical candidate, use surgical theater to provide spatial learning and comprehension through modeling so they better understand their surgical plan. Only the SRP system will be used for this study (Surgical Planner).

The intervention is showing surgical theater to patients identified for surgery in clinic routinely. Surgical theater will be offered to all patients offered surgery. No other changes in practice will be done.

Conditions

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Lumbar Spine Surgeries Cervical Spine Surgeries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Evaluation of usefulness

To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.

Group Type EXPERIMENTAL

Surgical Theater

Intervention Type DEVICE

The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient.

Interventions

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Surgical Theater

The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age range: 18-89.
2. Patients undergoing elective lumbar or cervical spine surgeries
3. Those who are receiving Surgical Theater consultation as part of their clinical care

Exclusion Criteria

1. Age \<18 years
2. Non-elective surgery due to emergency, trauma
3. Patients undergoing correction for spinal deformities
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Smith, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

University Hospitals at Southwest General Medical Center

Middleburg Heights, Ohio, United States

Site Status

Countries

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United States

References

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Altieri R, Melcarne A, Junemann C, Zeppa P, Zenga F, Garbossa D, Certo F, Barbagallo G. Inferior Fronto-Occipital fascicle anatomy in brain tumor surgeries: From anatomy lab to surgical theater. J Clin Neurosci. 2019 Oct;68:290-294. doi: 10.1016/j.jocn.2019.07.039. Epub 2019 Jul 19.

Reference Type BACKGROUND
PMID: 31331747 (View on PubMed)

Bambakidis NC, Selman WR, Sloan AE. Surgical rehearsal platform: potential uses in microsurgery. Neurosurgery. 2013 Oct;73 Suppl 1:122-6. doi: 10.1227/NEU.0000000000000099.

Reference Type BACKGROUND
PMID: 24051875 (View on PubMed)

Ehlers JP, Uchida A, Srivastava SK. THE INTEGRATIVE SURGICAL THEATER: Combining Intraoperative Optical Coherence Tomography and 3D Digital Visualization for Vitreoretinal Surgery in the DISCOVER Study. Retina. 2018 Sep;38 Suppl 1(Suppl 1):S88-S96. doi: 10.1097/IAE.0000000000001999.

Reference Type BACKGROUND
PMID: 29256988 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY20210810

Identifier Type: -

Identifier Source: org_study_id

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