Sequential Endoscopic Lung Volume Reduction

• Sponsor: Heidelberg University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00613860
• Collaborator: Humboldt-Universität zu Berlin (Other)
• Enrollment: 30
• Locations: 3
• Duration (Months): 47
• Patients Per Site: 10
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emphysema; COPD	Device: Zephyr endobronchial valve	Phase 3

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema
• Study Start Date: Jan 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: Dec 1, 2011

Outcome Measures

Primary Outcome Measures

1. FEV 1 6 Minute walk test [6 months after intervention]

Secondary Outcome Measures

1. Safety Symptom scores [6 months after intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Heterogenous emphysema

• FEV1 < 45%

• RV > 150%

• TLC > 100%

• TLCO < 40%

Exclusion Criteria:

• Homogeneous emphysema

• Pregnancy

• PCO2 > 50 mmHg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite, University of Berlin	Berlin		Germany	10117
2	Thoraxklinik, University of Heidelberg	Heidelberg		Germany	69190
3	Medical Center Nürnberg	Nürnberg		Germany	90340

Sponsors and Collaborators

• Heidelberg University
• Humboldt-Universität zu Berlin

Investigators

• Principal Investigator: Felix JF Herth, MD, PhD, Thoraxklinik University of Heidelberg

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00613860
• Other Study ID Numbers: 02/08
• First Posted: Feb 13, 2008
• Last Update Posted: Apr 27, 2011
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy
• Additional relevant MeSH terms: Pulmonary Emphysema; Emphysema

Study Results

No Results Posted as of Apr 27, 2011