NCT00884962

Brief Summary

This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 21, 2011

Status Verified

October 1, 2011

Enrollment Period

1.4 years

First QC Date

April 20, 2009

Last Update Submit

October 20, 2011

Conditions

Advanced Emphysema

Keywords

emphysemaaerisPLVRBLVRgermanytreatmentdevicebreathing

Outcome Measures

Primary Outcomes (1)

  • Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)

    Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment

    12 and 24 weeks following treatment

Secondary Outcomes (6)

  • Change in Forced Expiratory Volume in 1 Second (FEV1)

    12 and 24 weeks following treatment

  • Change in Forced Vital Capacity (FVC)

    12 and 24 weeks following treatment

  • Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco)

    12 and 24 weeks following treatment

  • Change in Medical Research Council Dyspnea (MRCD) score

    12 and 24 weeks following treatment

  • Change in distance walked in six minutes

    12 and 24 weeks following treatment

  • +1 more secondary outcomes

Study Arms (1)

PLVR

EXPERIMENTAL
Device: Polymeric Lung Volume Reduction System (PLVR)

Interventions

Polymeric Lung Volume Reduction System (PLVR)DEVICE

20ml (each) of polymer will be injected into 2, 3 or 4 subsegments during the first treatment. Eligible patients may have 20ml (each) of polymer will be injected into 2 or 3 subsegments during the second treatment.

PLVR

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a diagnosis of advanced upper lobe predominant (ULP) emphysema or advanced disease in the superior lower lobes as defined by FEV1/FVC \<70 % predicted, FEV1 of \< 50% predicted, TLC \> 100% of predicted, and RV \> 135% predicted.
  • Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
  • Patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the pre-specified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chefarzt Klinik für Pneumologie

Bad Berka, Germany

Location

Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie

Berlin, Germany

Location

Pneumologisches Forschungsinstitut

Großhansdorf, Germany

Location

Thoraxklinik Heidelberg

Heidelberg, Germany

Location

Lungenklinik Hemer

Hemer, Germany

Location

Medizinische Klinik und Poliklinik Klinikum Großhadern

Munich, Germany

Location

Related Publications (2)

  • Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

    PMID: 33590989DERIVED

  • Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.

    PMID: 22374920DERIVED

MeSH Terms

Conditions

EmphysemaRespiratory Aspiration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

December 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 21, 2011

Record last verified: 2011-10

Locations

DE(6)