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Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations

NCT ID: NCT04016363

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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Pharmacological stress-echocardiography examinations are routinely performed in daily clinical practice. Usually, the echo probe is manually placed on the patient's thorax by the physician. The ProbeFix is a novel device, enabling the fixation of the ultrasound probe on the patient's thorax. Therefore, there is no need to manually hold the probe. This may improve the standardization of the examination and my reduce its duration. The present trial will investigate, whether the utilization of the ProbeFix reduces the duration of stress-echocardiography examinations and improves standardization of image acquisition.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ProbeFix arm

The echocardiography probe is fixated on the patient's thorax using the ProbeFix

Group Type EXPERIMENTAL

ProbeFix

Intervention Type OTHER

ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Controll arm

The sonographer manually holds the probe on the patient's thorax

Group Type ACTIVE_COMPARATOR

Manual hold

Intervention Type OTHER

ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Interventions

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ProbeFix

ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Intervention Type OTHER

Manual hold

ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing clinically indicated pharmacological stress-echocardiography
* Willingness to participate

Exclusion Criteria

* Pharmacological stress echocardiography indication other than evaluation of stress induced ischemia (e.g. Low-Flow-Low-Gradient aortic valve stenoseis)
* poor image quality
* Early termination of the stress-echocardiography examination for clinical reasons
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amir Abbas Mahabadi

OTHER

Sponsor Role lead

Responsible Party

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Amir Abbas Mahabadi

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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19-TEMP815870-BO

Identifier Type: -

Identifier Source: org_study_id