Post Market Observational, Prospective, Multi-center Study | NCT01806636

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jul 2019Actual

Completion Date

Jul 2019Actual

First Submitted Date

Feb 17, 2013

First Submission Date that Met QC Criteria

Mar 5, 2013

First Posted Date

Mar 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2021

Last Update Posted Date

Jul 16, 2021Actual

Name	Class
PneumRx, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,275Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment		Patients treated with PneumRx Coil System	Device: PneumRx Coil System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PneumRx Coil System	Device		Treatment	RePneu LVRC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Quality of Life (QOL) measures		6 months and yearly up to three years post treatment 1

Secondary Outcomes

Measure	Description	Time Frame
Changes in Pulmonary Function and Exercise Capacity test results		6 months and yearly up to three years post treatment 1
Safety including any device malfunction or failure(s)		6 months and yearly up to three years post treatment 1

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Hetzel, Prof.	Krankenhaus vom Roten Kreuz	Principal Investigator
Christian Schumann, MD	Klinikenverbund Kempten-Oberallgäu	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Otto-Wagner-Spital		Vienna		1140	Austria
Rigshospitalet Copenhaven

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Italy

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms