NCT00613860

Brief Summary

Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
withdrawn

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

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

3.9 years

First QC Date

January 31, 2008

Last Update Submit

August 30, 2022

Conditions

EmphysemaCOPD

Keywords

Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy

Outcome Measures

Primary Outcomes (1)

  • FEV 1 6 Minute walk test

    6 months after intervention

Secondary Outcomes (1)

  • Safety Symptom scores

    6 months after intervention

Interventions

Zephyr endobronchial valveDEVICE

Endobronchial valve system to redirect the airflow within the bronchial system

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heterogenous emphysema
  • FEV1 \< 45%
  • RV \> 150%
  • TLC \> 100%
  • TLCO \< 40%

You may not qualify if:

  • Homogeneous emphysema
  • Pregnancy
  • PCO2 \> 50 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Charite, University of Berlin

Berlin, 10117, Germany

Location

Thoraxklinik, University of Heidelberg

Heidelberg, 69190, Germany

Location

Medical Center Nürnberg

Nuremberg, 90340, Germany

Location

Related Publications (5)

  • Strange C, Herth FJ, Kovitz KL, McLennan G, Ernst A, Goldin J, Noppen M, Criner GJ, Sciurba FC; VENT Study Group. Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction. BMC Pulm Med. 2007 Jul 3;7:10. doi: 10.1186/1471-2466-7-10.

    PMID: 17711594BACKGROUND

  • de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190.

    PMID: 16840401BACKGROUND

  • Venuta F, de Giacomo T, Rendina EA, Ciccone AM, Diso D, Perrone A, Parola D, Anile M, Coloni GF. Bronchoscopic lung-volume reduction with one-way valves in patients with heterogenous emphysema. Ann Thorac Surg. 2005 Feb;79(2):411-6; discussion 416-7. doi: 10.1016/j.athoracsur.2004.07.048.

    PMID: 15680805BACKGROUND

  • Yim AP, Hwong TM, Lee TW, Li WW, Lam S, Yeung TK, Hui DS, Ko FW, Sihoe AD, Thung KH, Arifi AA. Early results of endoscopic lung volume reduction for emphysema. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1564-73. doi: 10.1016/j.jtcvs.2003.10.005.

    PMID: 15173708BACKGROUND

  • Shah PL, Gompelmann D, Valipour A, McNulty WH, Eberhardt R, Grah C, Egan J, Ficker JH, Wagner M, Witt C, Liebers U, Hopkins P, Gesierich W, Phillips M, Stanzel F, Petermann C, Strange C, Snell G, Herth FJF. Thermal vapour ablation to reduce segmental volume in patients with severe emphysema: STEP-UP 12 month results. Lancet Respir Med. 2016 Sep;4(9):e44-e45. doi: 10.1016/S2213-2600(16)30199-0. Epub 2016 Jul 20. No abstract available.

    PMID: 27451345RESULT

MeSH Terms

Conditions

EmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Study Officials

  • Felix JF Herth, MD, PhD

    Thoraxklinik University of Heidelberg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

April 1, 2012

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations

DE(3)