Sequential Endoscopic Lung Volume Reduction

NCT ID: NCT00613860

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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

Conditions

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Emphysema COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zephyr endobronchial valve

Endobronchial valve system to redirect the airflow within the bronchial system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Homogeneous emphysema
* Pregnancy
* PCO2 \> 50 mmHg
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humboldt-Universität zu Berlin

OTHER

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Felix JF Herth

CEO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felix JF Herth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Thoraxklinik University of Heidelberg

Locations

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Charite, University of Berlin

Berlin, , Germany

Site Status

Thoraxklinik, University of Heidelberg

Heidelberg, , Germany

Site Status

Medical Center Nürnberg

Nuremberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 17711594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16840401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15680805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15173708 (View on PubMed)

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.

Reference Type RESULT
PMID: 27451345 (View on PubMed)

Other Identifiers

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02/08

Identifier Type: -

Identifier Source: org_study_id

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