Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures

NCT01902732 | Unknown Phase 2

• 1 other identifier: Protocol G1.0.- 16.02.2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

This clinical trial evaluates the impact of catheter-based measurement of interloabr collateral ventilation prior to endoscopic lung volume reduction in patients with hetereogeneous emphysema and complete interlobar fissures in high resolution computed tomography.

Conditions

Heterogeneous Emphysema

Outcome Measures

Primary Outcomes (1)

• Improvement on pulmonary function

  Development of lung function parameters FEV1 and RV/TLC. Increase of FEV1 of 15% and decrease of RV/TLC of 10% compared to baseline will be considered as clinically significant.

  12 months

Secondary Outcomes (1)

• Assessment of safety and efficacy

  12 months

Study Arms (1)

Implantation of valves (IBV)

OTHER

Following catheter-based measurement of collaertal ventilation, each patient is treated by a complete occlusion of the targeted lobe by intrabronchial valves.

Device: Implantation of valves (IBV)

Interventions

Implantation of valves (IBV) DEVICE

Implantation of intrabronchial valves in the most emphysematous destroyed and hyperinflated lung lobe improves the elastic recoisl of the samll airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function. This positive effect is observed particularly in patients with low interlobar collateral ventilation that can be quantified by CT fissure analysis and/or catheter-based measurement.

Also known as: Spiration(R) valves

Implantation of valves (IBV)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• ability to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements
• severe lung emphysema (FEV1\<45%, RV\>150%, TLC\>100%)
• pO2\>60 mmHg with 4l O2, pCO2 \< 60 mmHg at rest
• heterogeneous lung emphysema diagnosed with HRCT and perfusion scintigraphy
• confirmed heterogeneity by YACTA®
• disclosure of parallel channels through relevant interlobar fissures
• age \> 30 years
• stable COPD without exacerbation 8 weeks prior to screening
• dose of cortisone\< 20 mg prednisone or equivalent OCS
• non-smoker or ex-smoker who stopped smoking for at least 4 months prior to the screening visit
• current CoHb \< 2,5%

You may not qualify if:

• BMI \< 18 mg/kg2
• significant bronchiectasis with sputum production of 4 tablespoons/day
• minute-walk distance \< 150 m
• myocardial infarction within 6 weeks prior screening visit
• decompensated heart failure
• cardiomyopathy with moderate or severe restricted LVF
• long-term medication with Clopidogrel
• status after lung resection (Lobectomy/Pneumonectomy)
• existing pregnancy
• female subjects of child-bearing potential without acceptable forms of contraception

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (5)

LungenClinic Grosshansdorf

Großhansdorf, 22927, Germany

RECRUITING

LungenClinic Grosshansdorf

Großhansdorf, 22927, Germany

RECRUITING

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

RECRUITING

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

RECRUITING

Thoraxklinik

Heidelberg, 69126, Germany

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Felix JF Herth

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: July 18, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

DE (5)