Trials / Recruiting
RecruitingNCT06655428
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - A Pilot Study (CSP-12123)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Morair Medtech, LLC · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to learn if bronchoscopic lung volume reduction with endobronchial thermal liquid ablation (ETLA) works to treat severe emphysema in terms of feasibility and safety. Participants will: * Have up to two ETLA procedures * Complete five clinic follow-up visits and two virtual follow-up visits.
Detailed description
ETLA offers the potential to result in significant lung volume reduction of hyperinflated emphysematous regions, providing clinically meaningful improvement in pulmonary function and quality of life to a broad population of patients with severe emphysema. The REDUCE EU Pilot study will primarily evaluate the feasibility and safety of ETLA treatment in patients with severe emphysema. Secondarily, the study will evaluate the efficacy of sequential ETLA treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endobronchial Therman Liquid Ablation (ETLA) | The ETLA System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted emphysematous lung regions with hyperinflation to cause tissue ablation and subsequent volume reduction as a means for treating emphysema. The ETLA procedures will be performed under general anesthesia. Each procedure will be limited to treatment in a single lung, with either unilateral or bilateral treatment over the two procedures. |
Timeline
- Start date
- 2025-01-10
- Primary completion
- 2026-02-01
- Completion
- 2026-05-01
- First posted
- 2024-10-23
- Last updated
- 2025-01-28
Locations
7 sites across 3 countries: Austria, Germany, Netherlands
Source: ClinicalTrials.gov record NCT06655428. Inclusion in this directory is not an endorsement.