Impact of the ProbeFix on the Workflow of Pharmacological... | NCT04016363

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

NCT04016363

Sponsor

Amir Abbas Mahabadi

Status

Withdrawn

Last Update Posted

Oct 15, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

ProbeFix
Manual hold

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Industrial partner was not able to provide funding

Expanded Access Info

Start Date

Jan 1, 2020Estimated

Primary Completion Date

Dec 30, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jul 8, 2019

First Submission Date that Met QC Criteria

Jul 8, 2019

First Posted Date

Jul 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2021

Last Update Posted Date

Oct 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ProbeFix arm	Experimental	The echocardiography probe is fixated on the patient's thorax using the ProbeFix	Other: ProbeFix
Controll arm	Active Comparator	The sonographer manually holds the probe on the patient's thorax	Other: Manual hold

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ProbeFix	Other	ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations	ProbeFix arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Essen		Essen	North Rhine-Westphalia	45147	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided