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A Pilot Study to Assess Treatment of Patients With Homogeneous Emphysema Using Sequential Segmental Bronchoscopic Thermal Vapor Ablation (NEXT STEP)

NCT03670121 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-11-15

No results posted yet for this study

Summary

This study is a Prospective, single arm, single center pilot study following outcomes for 12 months after initial BTVA treatment. The primary objectives of the study are to prospectively document the safety and efficacy of sequential segmental treatment with BTVA in patients with a homogeneous distribution of emphysema that are not candidates for endobronchial valve therapy.

Conditions

  • Emphysema or COPD

Interventions

DEVICE

Bronchoscopic Thermal Vapor Ablation (BTVA)

Bronchoscopic vapor delivery to airway segment(s) targeted for treatment

Sponsors & Collaborators

  • MedPass International

    collaborator INDUSTRY

  • Uptake Medical Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Felix Herth · Univ.-Prof. Felix JF Herth, Thoraxklinik University of Heidelberg Heidelberg, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2020-06-12
Completion
2020-06-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03670121 on ClinicalTrials.gov