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

Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04016363

Enrollment

Registered

2019-07-11

Start date

2020-01-01

Completion date

2020-12-31

Last updated

2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

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.

Interventions

OTHERProbeFix

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

OTHERManual hold

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Duration of stress-echocardiography examination	During the examination	Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion

Secondary

Measure	Time frame	Description
Echocardiography axis deviation in 4 chamber view	During the examination	In 3-dimensional 4-chamber view, the deviation of the axis as compared to baseline will be assessed

Other

Measure	Time frame	Description
Cost-effectiveness	During the examination	Assessment of cost-effectiveness, comparing a potential benefit in exam duration with costs of the ProbeFix

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026