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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011372

Enrollment

Registered

2016-11-23

Start date

2018-01-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J43

Interventions

Group 1: In bronchoscopic thermal ablation hot water vapor is instilled into the most destroyed lung parenchyma to cause an inflammatory process. This inflammatory process leads to formation of scars

Eligibility

Sex/Gender

All

Age

30 Years to No maximum

Inclusion criteria

Inclusion criteria: - Serious pulmonary emphysema: FEV1 150%, TLC> 100%, maximum drug therapy according to GOLD blood gases: PO2> 45 mmHg at room air at rest; PCO2 30 years -Stable COPD: No exacerbation in the last 8 weeks; Cortisone dose 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

Exclusion criteria: -Nutritional status: BMI 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

Design outcomes

Primary

Measure	Time frame
Safety: Evaluation of the number of complications caused by the treatment (so-called adverse or severe adverse events)	—

Secondary

Measure	Time frame
Effectiveness: • 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. • 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. • 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. • Average change in the volume of treated lung lobes in CT after 6 months	—

Measure

Time frame

Effectiveness: • 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. • 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. • 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. • Average change in the volume of treated lung lobes in CT after 6 months

—

Countries

Germany

Contacts

Public ContactBrigitte Rump

Thoraxklinik Universitätsklinikum Heidelberg

brigitte.rump@med.uni-heidelberg.de06221/396-1211

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026