Endoscopic thermal vapor ablation in patients with homogenous lung emphysema-a pilot study

Phase 1

• Conditions: J43; Emphysema

• Registration Number: DRKS00011372
• Lead Sponsor: Thoraxklinik Universitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Serious pulmonary emphysema:
FEV1 <45%, RV> 150%, TLC> 100%, maximum drug therapy according to GOLD
blood gases:
PO2> 45 mmHg at room air at rest; PCO2 <55 mmHg with room air at rest
-Homogeneity:
Homogenous pulmonary emphysema, which was already detected prior to study inclusion by a thoracic HCRT and a perfusion scintigraphy; Confirmation of homogeneity by computer-assisted emphysem quantification (YACTA®)
-patient age:> 30 years
-Stable COPD:
No exacerbation in the last 8 weeks; Cortisone dose <20 mg prednisolone equivalent
-Not- or ex-smoker:
Nicotine abstinence> 4 months; Current CoHb <2.5%
-Patient informed consent:
Signed patient information for an endoscopic LVR; Willingness to participate in the control investigations according to the protocol

Exclusion Criteria

-Nutritional status:
BMI <18 mg / kg²
Significant bronchiectasis:
Sputum quantity> 4 tablespoons /day
-physical resilience:
Walking distance <140 m
- Difficult cardiac disease:
Z. n. Myocardial infarction in the last 6 weeks; Decompensated heart failure; Cardio-myopathy with medium to highly limited LVF; Long term medication with Clopidogrel
-Pre-operations:
Z.n. Lung resection (LVRS / lobectomy / pneumonectomy)
-Pregnancy:
Existing pregnancy; Female subject of childbearing age without adequate contraception

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety:<br>Evaluation of the number of complications caused by the treatment (so-called adverse or severe adverse events)

Secondary Outcome Measures

Name	Time	Method
Effectiveness:<br>• Average changes in lung function (FEV1, IVC, RV, TLC, RV / TLC) at the time 30 days, 90 days, 180 days and 365 days after ELVR.<br>• Average changes in quality of life (SGRQ) and dyspnoea (mMRC) at the time of 30 days, 90 days, 180 days and 365 days after ELVR.<br>• Average changes in the walking distance of the 6 minute walking test at the time 30 days, 90 days, 180 days and 365 days after ELVR.<br>• Average change in the volume of treated lung lobes in CT after 6 months