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Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)

NCT ID: NCT02278445

Last Updated: 2015-12-02

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WITHDRAWN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

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

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Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- 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 (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.

Detailed Description

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Conditions

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Systemic Sclerosis Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Doppler ultrasound

Recording Doppler ultrasound noninvasively from the right chest wall

Group Type EXPERIMENTAL

Doppler ultrasound

Intervention Type RADIATION

Recording Doppler ultrasound noninvasively from the right chest wall

Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)

Intervention Type DEVICE

Interventions

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Doppler ultrasound

Recording Doppler ultrasound noninvasively from the right chest wall

Intervention Type RADIATION

Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Echosense Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merav Lidar, Dr

Role: PRINCIPAL_INVESTIGATOR

Sheba medical center, Rheumatology department

Locations

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Sheba Medical Center, Pulmonology department

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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DOP22_3

Identifier Type: -

Identifier Source: org_study_id