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LenusPro Safety (LPS) Study in Patients With PH

NCT ID: NCT01979822

Last Updated: 2013-11-08

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-09-30

Brief Summary

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The clinical study aims to investigate the numbers of predefined complications in the first six month after implantation of the implantable LENUS Pro® medications pump for intravenous application of treprostinil sodium in patients with PAH.

The manufacturer is Tricumed GmbH, Germany; exclusive marketing rights: OMT GmbH \& Co KG 78665 Frittlingen, Germany.

Detailed Description

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The previously used fully implantable pumps have been improved by development of additional safety options (e.g. acoustic occlusion alarm) for use in patients with PH. In the meantime, the pump (manufacturer: Tricumed GmbH, Germany, exclusively marketing rights: OMT GmbH \& Co KG, 78665 Frittlingen, Germany) is offered with an option that meets the requirements for use in treating PH patients. It is based on a constant flow system that consists of gas driven micro-infusion via a chip capillary. The medication is filled into a titanium reservoir via a so-called filling septum (silicon membrane). The membrane is punctured percutaneously with a special needle by specially trained personnel for filling under aseptic conditions. Various safety options ensure a continuous flow rate of the medication and signalize any malfunctions. If catheter occlusion is signalized, the catheter can be rinsed through a second septum in the pump after a percutaneous puncture without emptying the medication reservoir. The pump is available in two sizes (20 ml or 40 ml filling volume). The flow rate set for the 20 ml pump is 1.0 ml/ 24 hours, so that refilling is required every 19 to 20 days. The flow rate set for the 40 ml pump is 2.3 ml/ 24 hours, so that refilling is required every 29 to 30 days. Initial experience with the use of this pump has shown good results for up to 3 years of use (minor complications during implantation, no pump defects in long-term usage, reliable filling under outpatient conditions).

R. Ewert; M. Halank, L. Bruch; H.A. Ghofrani. The implantable pump - a new option for intravenous therapy in patients with severe pulmonary hypertension. Am J Respir Crit Care 2012;186:1196-98 Steringer-Mascherbauer R., Eder V., Ebner Ch. et al. First experience with intravenous treprostinil delivered by an implantable pump (Lenus Pro®) with filling intervals of 28 days in a patient with pulmonary arterial hypertension (PAH) - a case report. ATS Poster Desole S, Velik-Salchner C, Fraedrich G et al. Subcutaneous implantation of a new intravenous pump system for prostacyclin treatment in patients with pulmonary arterial hypertension. Heart Lung 2012 Aug 21. \[Epub ahead of print\]

Such pumps have been implanted in more than 90 patients in various European countries during the past 3 years. Experience shows that most of the patients selected for implantation have FC II-IV under combination therapy (2-3 specific PH-medications). The previous medication was either regarded as insufficient in respect to cardiopulmonary stabilization or the side effects of the therapy were intolerable. The latter applied particularly to patients with subcutaneous delivery of treprostinil in fairly large doses.

Given the previous application of the LENUS Pro® pump in the context of individualized healing attempts, the initiators of the planned study consider that it is necessary to ascertain the safety of this fully implantable pump system in a controlled prospective study.

Conditions

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Pulmonary Hypertension

Keywords

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medication pump, complications, safety observation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PH patients with LenusPro pump

Patient Inclusion Criteria:

1. Patient aged ≥ 18 years;
2. diagnosed with Pulmonary Arterial Hypertension (WHO) Category Group 1
3. Patient is in stable clinical condition and
4. the previous specific PH medication has been retained unchanged during the past 3 weeks

PH patients with LenusPro pump

Intervention Type OTHER

Observation/measurement of complications in PH patients with LenusPro pump in the frist six month after implantation of pump

Interventions

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PH patients with LenusPro pump

Observation/measurement of complications in PH patients with LenusPro pump in the frist six month after implantation of pump

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patient aged ≥ 18 years Patient (or patient's legally authorized representative) is willing and able to provide written informed consent Patient is willing and able to comply with the protocol, including required follow-up visits Patient is diagnosed with Pulmonary Arterial Hypertension (World Health Organization (WHO) Category Group 1 (by the WHO Clinical classification system), including Idiopathic (IPAH), Heritable PAH (HPAH) (Familial PAH), and PAH associated with other diseases (APAH), Patient is receiving continuous infusion of treprostinil via subcutaneous or intravenous delivery using an external pump system Patient is in stable clinical condition und the previous specific PH medication has been retained unchanged during the past 3 weeks Patient's anticoagulation therapy can be managed to permit safe device implantation


Hepatic insufficiency (Child C) Patient is a person whose body size is not sufficient to accept implantable pump bulk and weight as determined by the implanting surgeon Unacceptably high anesthetic risk as determined by the treating anesthesiologist Concomitant medication or underlying disease associated with an increased infection risk (e.g., intravenous drug abuse, diabetic gangrene) Patient is not in stable condition, especially a manifestation of decompensated right heart failure within three weeks prior to Baseline visit Patients with significantly increased bleeding risk due to comorbidities (e.g. hereditary F VIII deficiency, myeloproliferative neoplasm) Estimated life expectancy \< 6 months due to comorbidities (e.g. terminal malignancy)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Prof. Ralf Ewert

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralf Ewert, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Greifswald

Locations

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Krankenhaus der Elisabethinen Linz

Linz, , Austria

Site Status RECRUITING

University Hospital of Greifswald

Greifswald, Germany, Germany

Site Status RECRUITING

Universitätsklinik Giessen

Giessen, , Germany

Site Status RECRUITING

VU University Medical Center

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Countries

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Austria Germany Netherlands

Facility Contacts

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Regina Maschebauer, M.D.

Role: primary

Ralf Ewert, M.D.

Role: primary

Ardeschir Ghofrani, M.D.

Role: primary

Anco Boonstra, M.D.

Role: primary

Other Identifiers

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LPS-1-2013

Identifier Type: OTHER

Identifier Source: secondary_id

LPS-1

Identifier Type: -

Identifier Source: org_study_id