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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03198468
Other study ID # CSP-2402
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 21, 2018
Est. completion date August 20, 2019

Study information

Verified date November 2021
Source Uptake Medical Technology, Inc.
Contact n/a
Is FDA regulated No
Health authority
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 inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment. Patients will receive BTVA-C treatment followed by standard-of-practice surgical resection.


Description:

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Study Design


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 (an energy level of 330 calories).

Locations

Country Name City State
Australia The Royal Melbourne Hospital Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Uptake Medical Technology, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary AEs and SAEs related to BTVA-C procedure The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure. Day 30 follow-up
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 navigational plan 1 day post-ablation
Primary Ischemic tissue assessment CT Imaging to identify and assess ischemic tissue 2-4 days post-ablation (pre surgical resection)
Primary Tissue necrosis evaluated by semi-quantitative histological analysis Semi-quantitative scoring of necrotic tissue assessed by histology 1 day post-surgical resection
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