Vapor Ablation for Localized Cancer Lesions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUptake Medical Technology, Inc.
About this trial
This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic cancer in the lung. Patients who have consented to participate in this study (enrolled) will be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C procedure. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment.
Patients will be followed for up to 12 months.
Eligibility criteria
Qualifiers
Age: ≥ 18 years old
Patient has been recommended for ablation or recommended for an alternative to surgery
Non-small cell lung cancer tumor(s) ≤ 2cm (T1aN0, T1bN0) OR Metastatic lung tumor(s) ≤ 2cm
Microscopic proof of malignancy obtained
Disqualifiers
Centralized tumor (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)
Carcinoid lung tumors
Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion
Pulmonary function tests (PFTs): post-bronchodilator forced expired volume in one second (FEV1) <20% predicted, diffusing capacity of the lung for carbon monoxide (DLCO)<20% predicted
Trial design
Treatments tested in this trial
- Bronchoscopic Thermal Vapor Ablation
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov