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JOURNAL ONKOLOGIE – STUDIE
VAPORIZED

Vapor Ablation for Localized Cancer Lesions

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NCT-Nummer:
NCT03514329

Studienbeginn:
September 2024

Letztes Update:
27.02.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Uptake Medical Technology, Inc.

Collaborator:
-

Kontakt

Studienlocations
(2 von 2)

Studien-Informationen

Detailed 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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. BTVA-C related AEs/SAEs (Time Frame - up to 6 months post-ablation):
The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.

2. Successful BTVA-C Treatment Delivery (Time Frame - Day 0):
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

3. Local Control Evaluation per RECIST (Time Frame - Month 1, 3, 6, and 12):
Evaluation in the change in response to vapor ablation based on the RECIST 1.1 protocol

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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