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LenusPro Pump in PAH Treated With Treprostinil

NCT02889315 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2021-08-19

No results posted yet for this study

Summary

Subcutaneous treprostinil is used to treat pulmonary arterial hypertension (PAH). Due to local pain it causes a deterioration of quality of life or even abandonment of treatment. The aim of this study was to evaluate the safety and quality of life (QoL) in patients treated with treprostinil administration using an implantable Lenus Pro® pump. This is a observational study involving patients with PAH treated with a subcutaneous infusion of treprostinil with intolerable pain at the infusion site, who were therefore referred for pump implantation. Clinical evaluation, including QoL assessment with SF-36 questionnaire was performed at the time of initiating therapy with treprostinil, before and 2-9 months after implantation.

Conditions

Sponsors & Collaborators

  • Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2021-09-30
Completion
2023-12-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889315 on ClinicalTrials.gov