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Sequential Endoscopic Lung Volume Reduction

Primary Purpose

Emphysema, COPD

Status
Withdrawn
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Zephyr endobronchial valve
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Homogeneous emphysema
  • Pregnancy
  • PCO2 > 50 mmHg

Sites / Locations

  • Charite, University of Berlin
  • Thoraxklinik, University of Heidelberg
  • Medical Center Nürnberg

Outcomes

Primary Outcome Measures

FEV 1 6 Minute walk test

Secondary Outcome Measures

Safety Symptom scores

Full Information

First Posted
January 31, 2008
Last Updated
August 30, 2022
Sponsor
Heidelberg University
Collaborators
Humboldt-Universität zu Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT00613860
Brief Title
Sequential Endoscopic Lung Volume Reduction
Official Title
Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
complicated patient enrollment
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Humboldt-Universität zu Berlin

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, COPD
Keywords
Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Zephyr endobronchial valve
Intervention Description
Endobronchial valve system to redirect the airflow within the bronchial system
Primary Outcome Measure Information:
Title
FEV 1 6 Minute walk test
Time Frame
6 months after intervention
Secondary Outcome Measure Information:
Title
Safety Symptom scores
Time Frame
6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heterogenous emphysema FEV1 < 45% RV > 150% TLC > 100% TLCO < 40% Exclusion Criteria: Homogeneous emphysema Pregnancy PCO2 > 50 mmHg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD, PhD
Organizational Affiliation
Thoraxklinik University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite, University of Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Thoraxklinik, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69190
Country
Germany
Facility Name
Medical Center Nürnberg
City
Nürnberg
ZIP/Postal Code
90340
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17711594
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. doi: 10.1186/1471-2466-7-10.
Results Reference
background
PubMed Identifier
16840401
Citation
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.
Results Reference
background
PubMed Identifier
15680805
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. doi: 10.1016/j.athoracsur.2004.07.048.
Results Reference
background
PubMed Identifier
15173708
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. doi: 10.1016/j.jtcvs.2003.10.005.
Results Reference
background
PubMed Identifier
27451345
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 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.
Results Reference
result

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Sequential Endoscopic Lung Volume Reduction

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