Back to resultsHeartGuide: Preliminary Study (HG-1)
Primary Purpose
Cardiac Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
recording of the probe position
Sponsored by
About this trial
This is an interventional other trial for Cardiac Disease focused on measuring Echocardiography, Guidance algorithm
Eligibility Criteria
Inclusion Criteria:
- Patients (male or female) older than 18 years,
- Patient having a scheduled cardiac ultrasound outside any emergency context,
- Patients who have not objected to participating in the research (at the latest on the day of inclusion and before any examination required by the research),
- Subjects affiliated or benefiting from a social security plan,
- Women of childbearing age who are using effective contraception.
Exclusion Criteria:
- Person under legal protection (legal protection, guardianship or curatorship),
- Person deprived of liberty by judicial or administrative decision,
- Person who is unable to give his/her non-opposition,
- Pregnant or breastfeeding women.
Sites / Locations
- CHU de BordeauxRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients
Arm Description
Patient with an echocardiography examination
Outcomes
Primary Outcome Measures
Probe position
Difference between actual probe position and predicted position with guidance algorithm
Secondary Outcome Measures
Percentage of matches between algorithm and expert
Full Information
NCT ID
NCT05490303
First Posted
July 29, 2022
Last Updated
October 13, 2022
Sponsor
University Hospital, Bordeaux
Collaborators
DESKi
1. Study Identification
Unique Protocol Identification Number
NCT05490303
Brief Title
HeartGuide: Preliminary Study
Acronym
HG-1
Official Title
Development of Guidance Algorithms for Acquisition of Echocardiographic Reference Views
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
DESKi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Echocardiography is the examination of choice for the study of cardiac pathologies. Interest of echocardiography for other medical specialties has already been demonstrated (intensive care in the case of hemodynamic failure - in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnea).
The expansion of echocardiography'use has been catalyzed by miniaturization of echographic systems and decrease in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost.
Therefore, it's possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional.
The last limit to this democratization is the training, especially for non-specialists (non-cardiologists).
Detailed Description
Since January 2019, echocardiography laboratory headed by Prof. Stéphane Lafitte and DESKi (start-up - Bordeaux) have been working on guiding non-experts through their cardiac ultrasound examination.
An algorithm indicating in real time if the view obtained corresponds to a reference view has already been validated. However, this algorithm does not tell the operator which movement would improve the image quality.
Thanks to advances in deep learning and by combining cardiac ultrasound acquisitions with systems that record the position of the probes in real time, it would be possible to develop an algorithm able to guide the operator's movements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
Keywords
Echocardiography, Guidance algorithm
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Other
Arm Description
Patient with an echocardiography examination
Intervention Type
Other
Intervention Name(s)
recording of the probe position
Intervention Description
For each patient, a cardiac ultrasound acquisition will be performed with an optical tracking system (infrared) recording the probe's position in real time.
Primary Outcome Measure Information:
Title
Probe position
Description
Difference between actual probe position and predicted position with guidance algorithm
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Percentage of matches between algorithm and expert
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients (male or female) older than 18 years,
Patient having a scheduled cardiac ultrasound outside any emergency context,
Patients who have not objected to participating in the research (at the latest on the day of inclusion and before any examination required by the research),
Subjects affiliated or benefiting from a social security plan,
Women of childbearing age who are using effective contraception.
Exclusion Criteria:
Person under legal protection (legal protection, guardianship or curatorship),
Person deprived of liberty by judicial or administrative decision,
Person who is unable to give his/her non-opposition,
Pregnant or breastfeeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane LAFITTE, MD,PhD
Phone
(0)5 57 65 64 85
Ext
+33
Email
stephane.lafitte@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bertrand MOAL, MD,PhD
Phone
(0)6 63 76 08 54
Ext
+33
Email
bertrand.moal@deski.io
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane LAFITTE, MD,PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane LAFITTE, MD,PhD
Phone
(0)5 57 65 64 85
Ext
+33
Email
stephane.lafitte@chu-bordeaux.fr
12. IPD Sharing Statement
Learn more about this trial
HeartGuide: Preliminary Study
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