Vapor Ablation for Localized Cancer Lesions

Lung Cancer Clinical Trial

— VAPORIZED  

Official title:

Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Definitive Treatment Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03514329
• Other study ID #: CSP-2315
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2023
• Source: Uptake Medical Technology, Inc.
• Contact: Gheda Sahyun
• Phone: 650-823-9093
• Email: gsahyun[@]broncus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Subjects identified for this study will be those that have microscopic proof of malignancy. Patients who have consented to participate in this study (enrolled) will undergo screening assessments to evaluate the inclusion criteria associated with their lung cancer and general health. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will be scheduled for treatment with the BTAV-C System. A total of 10 subjects will be treated at up to 3 investigational sites within the EU. Prior to the vapor ablation procedure, the patient's CT scan is analyzed to evaluate the location and size of the target lesion. The segments and airways associated with the lesion are identified and images are created to aid in the navigation to appropriate treatment locations during the upcoming procedure. At the time of the vapor ablation procedure, the Uptake catheter is placed in a selected airway with a thin bronchoscope. A balloon at the distal end of the catheter is then inflated to occlude the bronchus prior to vapor infusion. Sterile water is heated to approximately 100° - 140°C by a reusable generator and vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power. If necessary, the catheter is moved to the next airway and the procedure is repeated until all desired airways have been treated (maximum 3 treatments). The treatment creates a uniform field of necrosis in the parenchyma around the lesion. Patients will be evaluated for clinical symptoms in the 30-day period following ablation. Local control of the tumor will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) from low dose CT scans at 1, 3, 6 and 12 months following ablation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: = 18 years old

2. Patient has been recommended for ablation or recommended for an alternative to surgery

3. Non-small cell lung cancer tumor(s) = 2cm (T1aN0, T1bN0) OR Metastatic lung tumor(s) = 2cm

4. Microscopic proof of malignancy obtained

5. Location of tumor:

1. In periphery of lung (outermost 1/3)

2. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan

6. Signed patient informed consent

Exclusion Criteria:

1. Centralized tumor (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)

2. Carcinoid lung tumors

3. Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion

4. 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

5. Requirement for supplemental oxygen (includes at rest or during exercise)

6. Hospitalization for cardiac disease within the preceding 6 months

7. Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN)

8. Serum creatinine > 2 mg/dl

9. Recent infection (within 30 days)

10. Currently receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent)

11. Pre-existing implants within the airways that impede navigation to the target lesion

12. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.

13. 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.

14. 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

15. 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Metastatic Lung Cancer
• Non Small Cell Lung Cancer

Intervention

Device:
• Bronchoscopic Thermal Vapor Ablation
Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power.

Locations

Country	Name	City	State
Austria	Otto-Wagner Hospital	Vienna
Italy	Azienda Ospedaliero - Universitaria	Ancona

Sponsors (1)

Lead Sponsor	Collaborator
Uptake Medical Technology, Inc.

Countries where clinical trial is conducted

Austria,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Uptake Medical website