Vapor Ablation for Localized Cancer Lesions

NCT03514329 | Not Yet Recruiting FDA Device

• 1 other identifier: CSP-2315
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer; Metastatic Lung Cancer; Lung Cancer

Keywords

Non Small Cell Lung Cancer; Metastatic Lung Cancer; Lung Cancer; Vapor Ablation; BTVA

Outcome Measures

Primary Outcomes (3)

• BTVA-C related AEs/SAEs

  The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.

  up to 6 months post-ablation

• Successful BTVA-C Treatment Delivery

  Treatment meets 100% of the required procedural steps/requirements per the Instructions for Use (IFU) and treatment is delivered to the target tumor per the individual patient navigation plan

  Day 0

• Local Control Evaluation per RECIST

  Evaluation in the change in response to vapor ablation based on the RECIST 1.1 protocol

  Month 1, 3, 6, and 12

Study Arms (1)

Vapor Ablation

EXPERIMENTAL

Patients treated with Bronchoscopic Thermal Vapor Ablation for lung cancer

Device: Bronchoscopic Thermal Vapor Ablation

Interventions

Bronchoscopic Thermal Vapor Ablation DEVICE

Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power.

Also known as: BTVA-C

Vapor Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Location of tumor:
• In periphery of lung (outermost 1/3)
• Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
• Signed patient informed consent

You may not qualify if:

• 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
• Requirement for supplemental oxygen (includes at rest or during exercise)
• Hospitalization for cardiac disease within the preceding 6 months
• Liver enzymes (ALP, ALT, AST) or total bilirubin \> 1.5 upper limit of normal (ULN)
• Serum creatinine \> 2 mg/dl
• Recent infection (within 30 days)
• Currently receiving immunosuppressive medication or prednisone \> 10 mg/day (or equivalent)
• Pre-existing implants within the airways that impede navigation to the target lesion
• Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
• Disorder of coagulation, history of severe hemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedure and 10 days post-procedure.
• Any condition that in the opinion of the investigator or reviewer may interfere with the safety of the patient or evaluation of the study objectives
• Any tumor characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives.

Sponsors & Collaborators

• Uptake Medical Technology, Inc.: lead

Study Sites (2)

Otto-Wagner Hospital

Vienna, Austria

Location

Azienda Ospedaliero - Universitaria

Ancona, I-60020, Italy

Location

Related Links

• Uptake Medical website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Gheda Sahyun

CONTACT

650-823-9093; gsahyun@broncus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: May 2, 2018
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); AU (1)