Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01979822
Status:
UNKNOWN
Last Update Posted:
2013-11-08
First Post:
2013-09-25
Brief Title:
LenusPro Safety LPS Study in Patients With PH
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
LPS Lenus Pro Safety - Study in Pulmonary Hypertension PH
Status:
UNKNOWN
Status Verified Date:
2013-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
The manufacturer is Tricumed GmbH Germany exclusive marketing rights OMT GmbH Co KG 78665 Frittlingen Germany
Detailed Description:
The previously used fully implantable pumps have been improved by development of additional safety options eg 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 10 ml 24 hours so that refilling is required every 19 to 20 days The flow rate set for the 40 ml pump is 23 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 HA Ghofrani The implantable pump - a new option for intravenous therapy in patients with severe pulmonary hypertension Am J Respir Crit Care 20121861196-98 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
R Ewert M Halank L Bruch HA Ghofrani The implantable pump - a new option for intravenous therapy in patients with severe pulmonary hypertension Am J Respir Crit Care 20121861196-98 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LPS-1-2013 | OTHER | University of Greifswald | None |