Evaluating Lung Doppler Signals in Patients With Systemic... | NCT02246348

Studies
Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)

NCT02246348

Sponsor

Echosense Ltd.

Status

Terminated

Last Update Posted

Jan 21, 2016Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Systemic Sclerosis
Pulmonary Hypertension

Interventions

Doppler ultrasound

Countries

Israel

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

Aug 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment rate

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 17, 2014

First Submission Date that Met QC Criteria

Sep 18, 2014

First Posted Date

Sep 22, 2014Estimated

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

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS signals that are related to pulmonary hypertension.

The TPD performance in detecting PAH in SSc patients will be assessed in the study.

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

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doppler ultrasound	Experimental		Radiation: Doppler ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doppler ultrasound	Radiation	Recording Doppler ultrasound noninvasively from the right chest wall	Doppler ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.	Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension sevirity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical analysis success of the method in comparison to RHC data.	12 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to give signed informed consent prior to enrollment
Male or female, ≥ 18 years of age
Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
No change in or initiation of PAH specific therapy between the last RHC and TPD

Exclusion Criteria:

People unable or unwilling to give informed consent.
PCWP or LVEDP > 15 mmHg
Any PH etiology outside Group 1 (Dana Point, 2008)
Pregnant women
Patients having severe chest wall deformity

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

Name	Affiliation	Role
Alexsandra Balbir, Dr	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reumatology department, Rambam medical center		Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided