Pulmonary HypertensionNCT01979822
LenusPro Safety (LPS) Study in Patients With PH
An observational study of Pulmonary Hypertension, run by University Medicine Greifswald at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- PH patients with LenusPro pump
- How many people
- 30 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Feb 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from pulmonary centers
Who may be able to join
- Patient 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
Who cannot join
- Pregnancy, nursing Women of childbearing potential who are not on a reliable and safe form of contraception Patient is diagnosed with PH with an etiology different from that of the inclusion criteria, Patient is diagnosed with chronic kidney disease (estimated GFR <30) within ninety (90) days prior to Baseline visit; chronic kidney disease is defined as that lasting or expected to last more than three (3) months.
- 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)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinik Giessen
Giessen, D-35392
Ardeschir Ghofrani, M.D., ardeschir.ghofrani@uglc.de
Ardeschir Ghofrani, M.D.
- Recruiting
University Hospital of Greifswald
Greifswald, Germany, 17489
Ralf Ewert, M.D., +49-3834-8680595, ewert@uni-greifswald.de
Ralf Ewert, M.D.
Austria1 site, 1 recruiting
- Recruiting
Krankenhaus der Elisabethinen Linz
Linz, A- 4020
Regina Maschebauer, M.D., regina.mascherbauer@elisabethinen.or.at
Regina Maschebauer, M.D.
Netherlands1 site, 1 recruiting
- Not yet recruiting
VU University Medical Center
Amsterdam, NL-1081
Anco Boonstra, M.D., a.boonstra@vumc.nl
Anco Boonstra, M.D.
About this study
Official title: LPS (Lenus Pro Safety) - Study in Pulmonary Hypertension (PH)
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.
Read the detailed description
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).
- 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
- Pulmonary Hypertension
- Being tested
- PH patients with LenusPro pump
- Keywords
- medication pump, complications, safety observation
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH patients with LenusPro pumpOther
Observation/measurement of complications in PH patients with LenusPro pump in the frist six month after implantation of pump
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: PH patients with LenusPro pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of numbers of predefined complications in longterm treatment with LenusPro medication pump
Rate and type of predefined intraoperative complications (by implantation) as assessed by the implanting physician:
Measured: from implantation of pump (baseline) up to six month after implantation
Measurement of catheter (or pump) complications
Rate and type of predefined catheter (or pump) complications
Measured: from implantation of pump up to month six
Secondary outcomes (1)
Measurement of numbers of predefined refill complications
Refill complications, e.g. filling impossible because filling port cannot be found or fluoroscopy required to find filling port
Measured: from implanation of pump (baseline) up to six month after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Ralf Ewert, University Medicine Greifswald
- Investigators
- Ralf Ewert, M.D., Principal investigator, University Hospital of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979822
- Sponsor's protocol ID
- LPS-1
- Other IDs
- LPS-1-2013
- Status last verified
- Sep 2013
- First submitted
- 25 Sep 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LPS (Lenus Pro Safety) - Study in Pulmonary Hypertension (PH)
- ClinicalTrials.gov ID
- NCT01979822
- Acronym / sponsor ID
- LPS-1
- Conditions
- Pulmonary Hypertension
- Keywords
- medication pump, complications, safety observation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PH patients with LenusPro pump | – | Other: PH patients with LenusPro pumpPatient 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from pulmonary centers
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy, nursing Women of childbearing potential who are not on a reliable and safe form of contraception Patient is diagnosed with PH with an etiology different from that of the inclusion criteria, Patient is diagnosed with chronic kidney disease (estimated GFR <30) within ninety (90) days prior to Baseline visit; chronic kidney disease is defined as that lasting or expected to last more than three (3) months.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PH patients with LenusPro pumpObservation/measurement of complications in PH patients with LenusPro pump in the frist six month after implantation of pump | Other | PH patients with LenusPro pump |
Primary outcome
Measurement of numbers of predefined complications in longterm treatment with LenusPro medication pump
Time frame: from implantation of pump (baseline) up to six month after implantation
Rate and type of predefined intraoperative complications (by implantation) as assessed by the implanting physician:
Measurement of catheter (or pump) complications
Time frame: from implantation of pump up to month six
Rate and type of predefined catheter (or pump) complications
1 secondary outcome
Measurement of numbers of predefined refill complications
Time frame: from implanation of pump (baseline) up to six month after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
Related trials for Pulmonary Hypertension
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
RecruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
RecruitingPhase 4
Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
Pulmonary Arterial Hypertension
RecruitingPhase 3
Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH
Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Ewert, M.D. principal investigator
University Hospital of Greifswald
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by University Medicine Greifswald at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of numbers of predefined complications in longterm treatment with LenusPro medication pump (time frame: from implantation of pump (baseline) up to six month after implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013; AzTrials last refreshed its copy on 30 Oct 2026.