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Post Market Observational, Prospective, Multi-center Study

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ClinicalTrials.gov Identifier: NCT01806636
Recruitment Status : Recruiting
First Posted : March 7, 2013
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Brief Summary:
This registry is a post market observational, prospective, multi-center registry. It is designed to evaluate patient experience with the RePneu™ device for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product. In addition, the registry will collect information that will serve as the foundation for a cost effectiveness analysis.

Condition or disease Intervention/treatment
Emphysema Device: PneumRx Coil System

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Post Market Observational, Prospective, Multi-center Registry Using the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) System
Study Start Date : May 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Group/Cohort Intervention/treatment
Treatment
Patients treated with PneumRx Coil System
Device: PneumRx Coil System
Other Names:
  • RePneu
  • LVRC




Primary Outcome Measures :
  1. Changes in Quality of Life (QOL) measures [ Time Frame: 6 months and yearly up to 5 years post Tx1 ]

Secondary Outcome Measures :
  1. Changes in Pulmonary Function and Exercise Capacity test results [ Time Frame: 6 months and yearly up to 5 years post Tx1 ]
  2. Safety including any device malfunction or failure(s) [ Time Frame: 6 months and yearly up to 5 years post Tx1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients diagnosed with homogeneous or heterogeneous emphysema who are appropriate for Coil treatment based on the CE-Mark Approved IFU and who have been scheduled for treatment with the RePneu procedure will be eligible to participate in the Registry. If they agree and sign a consent form, they will then become study participants.
Criteria

Inclusion Criteria:

  • All adult patients diagnosed with homogeneous or heterogeneous emphysema who are appropriate for Coil treatment based on the CE-Mark Approved IFU and who have been scheduled for treatment with the RePneu procedure
  • RV of >175% predicted
  • Post bronchodilator FEV1 of ≤45% predicted.
  • Normal international normalized ratio (INR) in the absence of anticoagulation therapy
  • Participant read, understood and signed the Informed Consent form

Exclusion Criteria:

  • Known uncontrolled pulmonary hypertension defined by systolic RVP >50mmHg
  • Giant bullae > 1/3 lung volume
  • Patients on antithrombotic treatment (except for aspirin) which cannot be stopped 7 days prior to treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806636


Contacts
Contact: Jozef Tanczos +41 79 515 4691 jozef@pneumrx.com

  Show 63 Study Locations
Sponsors and Collaborators
PneumRx, Inc.
Investigators
Principal Investigator: Martin Hetzel, Prof. Krankenhaus vom Roten Kreuz
Principal Investigator: Christian Schumann, MD Klinikenverbund Kempten-Oberallgäu

Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01806636     History of Changes
Other Study ID Numbers: CLN0014
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Keywords provided by PneumRx, Inc.:
Coil
RePneu
PneumRx
LVRC

Additional relevant MeSH terms:
Emphysema
Pathologic Processes