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Trial record 5 of 10 for:    PneumRX [Lead]

Post Market Observational, Prospective, Multi-center Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01806636
Recruitment Status : Terminated
First Posted : March 7, 2013
Last Update Posted : August 8, 2019
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 endobronchial coil system for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product.


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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1275 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 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
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

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 three years post treatment 1 ]

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


Information from the National Library of Medicine

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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 and exclusion criteria in the Registry are based on CE Mark approved indication and approved Instructions for Use. Patients enrolled and treated in the Registry study should meet the requirements of the PneumRx Endobronchial Coil System Instructions for Use.

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


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

Additional Information:

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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: August 8, 2019
Last Verified: August 2019
Keywords provided by PneumRx, Inc.:
Coil
RePneu
PneumRx
LVRC
Additional relevant MeSH terms:
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Emphysema
Pathologic Processes