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Vapor Ablation for Localized Cancer Lesions

ConditionsNon Small Cell Lung CancerMetastatic Lung CancerLung Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Bronchoscopic Thermal Vapor Ablation

    Device

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Vapor AblationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

BTVA-C related AEs/SAEs

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

Time frame
up to 6 months post-ablation
2

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

Time frame
Day 0
3

Local Control Evaluation per RECIST

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

Time frame
Month 1, 3, 6, and 12

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uptake Medical Technology, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: