Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures

August 22, 2022 updated by: RealView Imaging
This study is intended to evaluate the use of the holographic display of 3D images acquired during ultrasound based cardiac procedures and to assess the clinical use of the HOLOSCOPE-i, in providing 3D spatial understanding to the clinician performing the procedure. Patients scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure will be enrolled to this study. In addition to the standard of practice imaging using ultrasound, patients anatomical structures will be evaluated using a 3D holographic system. The patients will complete their participation in the study, at the end of the procedure. No follow-up is required and patients will continue their routine medical care following the procedure.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

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

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to Fifty (50) patients undergoing elective procedures which use 3D echocardiography for treatment of structural heart disease.

Description

Inclusion Criteria:

  • Patients over the age of 18
  • Patients are scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure.

Exclusion Criteria:

  • Denial of informed consent
  • Any contraindications to three-dimensional echocardiographic imaging.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures
Time Frame: During procedure
Qualitative assessment using a Likert scale
During procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOLOSCOPE-i provides an intuitive understanding of the spatial relationship of the anatomy
Time Frame: During procedure
Qualitative assessment using a Likert scale
During procedure
HOLOSCOPE-i provides an intuitive understanding of the spatial relationship between the tool and the anatomy
Time Frame: During procedure
Qualitative assessment using a Likert scale
During procedure
Satisfaction with the use of the HOLOSCOPE-i under intra-procedural conditions
Time Frame: During procedure
Qualitative assessment using a Likert scale
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RealView Imaging

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 24, 2022

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-14-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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