A Feasibility Study of Local Effects of Thermal Vapor Ablation of Operable Cancer Lesions in the Lung

Phase 1

Withdrawn

• Conditions: Cancerous lung lesions; Cancer - Lung - Non small cell

• Registration Number: ACTRN12615000287538
• Lead Sponsor: ptake Medical Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Older than or equal to 18 years old
Less than or equal to 75 years old
2. Diagnosis of non-small cell lung cancer tumor less than or equal to 3 cm (T1N0 or T1N1) suitable for
resection
OR
Metastatic lung tumor less than or equal to 3cm suitable for resection
3. A suitable candidate for resection as per standard of practice at the surgical
center.
4. Location of tumor such that:
a. Resection would remove all gross tumor and ablation with grossly negative margins
b. Maximum of three vapor ablation applications would target entire margin
5. Signed informed consent forms

Exclusion Criteria

1. Suspected stage III or IV disease (if primary lung cancer)
2. Pretreatment chemotherapy or radiation therapy for targeted lesion
3. Pretreatment chemotherapy or radiation therapy for other lung related reasons <6
months prior
4. Preoperative proof of malignancy not obtained
5. Centralized tumor not amenable to lobectomy
6. Any condition that in the opinion of the Investigator may interfere with the safety
of the patient or evaluation of the study objectives
7. Receiving >20 mg daily prednisone dose
8. Pregnant or breastfeeding
9. Any tumor characteristic that in the opinion of the Investigator may interfere with
the safety of the patient or evaluation of the study objectives

Study & Design

• Study Type: Interventional
• Study Design: Not specified