Sequential Endoscopic Lung Volume Reduction

COPD Clinical Trial

Official title:

Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00613860
• Other study ID #: 02/08
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2008
• Est. completion date: April 2012

Study information

• Verified date: August 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too.

Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Heterogenous emphysema

• FEV1 < 45%

• RV > 150%

• TLC > 100%

• TLCO < 40%

Exclusion Criteria:

• Homogeneous emphysema

• Pregnancy

• PCO2 > 50 mmHg

Related Conditions & MeSH terms

• COPD
• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Zephyr endobronchial valve
Endobronchial valve system to redirect the airflow within the bronchial system

Locations

Country	Name	City	State
Germany	Charite, University of Berlin	Berlin
Germany	Thoraxklinik, University of Heidelberg	Heidelberg
Germany	Medical Center Nürnberg	Nürnberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Humboldt-Universität zu Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

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 volu — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV 1 6 Minute walk test		6 months after intervention
Secondary	Safety Symptom scores		6 months after intervention