Augmented Reality Headset as Adjunct Display Monitor in AMIGO

NCT03328416 | Withdrawn

• 1 other identifier: 2017P001456
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' overarching goal is to investigate whether use of an augmented reality display system (utilized in addition to, not as a replacement to, conventional CT and MRI displays currently available in the procedure suite) streamlines the process of a procedure and/or provides ease of access to helpful pre-procedure and intra-procedure imaging information that would be more difficult and time-consuming to obtain with the conventional imaging display systems.

Conditions

Malignancy; Infection; Pain

Keywords

Image-Guided Biopsy; Multidetector Computed Tomography; Diagnostic Imaging; Cryosurgery; Ablation Techniques

Outcome Measures

Primary Outcomes (1)

• Scores from NASA Task Load Index (TLX) with supplemental questions to assess procedure strain

  The NASA TLX method assesses work load on five 7-point scales and the additional questions assess procedural strain on 7-point scales. Each 7-point scale item will be assessed independently. Total scores will also be summed and assessed. Higher scores translate to a higher work load (worse outcome).

  15 minutes

Study Arms (1)

Augmented Reality

EXPERIMENTAL

The neurointerventional radiologist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling.

Device: Augmented Reality

Interventions

Augmented Reality DEVICE

The neurointerventional radiologist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling.

Augmented Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient referred to one of the study co-investigators for a procedure that requires either: Pre-procedure planning that utilizes either CT or MR images; Intra-procedure imaging for the purpose of needle placement.

You may not qualify if:

• Age under 18 at time of procedure.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Neoplasms; Infections; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas C Lee, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 1, 2017
• Study Start: January 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)