Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000287538
Ethics application status
Approved
Date submitted
20/02/2015
Date registered
26/03/2015
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility Study of Local Effects of Thermal Vapor Ablation of Operable Cancer Lesions in the Lung
Scientific title
A Feasibility Study of Local Effects of Thermal Vapor Ablation of Operable Cancer Lesions in the Lung
Secondary ID [1] 286214 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancerous lung lesions 294259 0
Condition category
Condition code
Cancer 294577 294577 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thermal Vapor ablation delivered to target lung areas (Cancerous Lesions).
One dose of 330 calories of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchoscopic procedure prior to lung resection.
Lung resection will then occur according to the standard hospital procedures.
The first two patients will have lung resection on the same day as the bronchoscopic delivery of Vapor. Subsequent patients will have lung resection performed up to 3 days post bronchoscopic delivery of vapour.
Intervention code [1] 291233 0
Treatment: Devices
Comparator / control treatment
Nil - feasibility study (FIH)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294358 0
To establish and confirm initial insight into the efficacy of the Uptake Medical Corp. TVA-LL system for ablation of primary and secondary cancer lesions in the lung.
Efficacy will be assessed by tissue staining being performed to assess tissue viability.
Timepoint [1] 294358 0
Tissue staining for viability will be performed in the period after surgical resection in alignment with standard pathology testing in post surgical resection patients.
Primary outcome [2] 294490 0
To establish and confirm initial insight into the safety of the Uptake Medical Corp. TVA-LL system for ablation of primary and secondary cancer lesions in the lung.
Safety will be measured by assessing the occurrence of all adverse events (serious and non-serious)
secondary to the thermal vapor ablation treatment from initiation of vapour ablation treatment through to the point of surgical resection.
Timepoint [2] 294490 0
From the period of initiation of thermal vapor ablation to the point of surgical resection.
Primary outcome [3] 294491 0
To establish and confirm initial insight into the feasibility of the Uptake Medical Corp. TVA-LL system for ablation of primary and secondary cancer lesions in the lung.
Feasibility will be assessed by evaluating that the thermal vapour ablation procedure can be successfully delivered with the equipment available in the bronchoscopy suite.
Timepoint [3] 294491 0
At the conclusion of the delivery of thermal vapour ablation in the bronchoscopy suite.
Secondary outcome [1] 313099 0
Gross observation of ablated tissue.
Timepoint [1] 313099 0
At the conclusion of the tissue staining and analysis process
Secondary outcome [2] 313451 0
Characterisation of the necrotic region via imaging (if taken - optional to clinician discretion)
Timepoint [2] 313451 0
To be analysed in the period following thermal vapour ablation just prior to surgical resection (in interval patients if CT option taken by clinician)
Secondary outcome [3] 313460 0
Characterisation of adjacent tissue effect from imaging (if taken)
Timepoint [3] 313460 0
To be analysed in the period following thermal vapour ablation just prior to surgical resection (in interval patients if CT option taken by clinician)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2015
Actual
Date of last participant enrolment
Anticipated
29/05/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3484 0
The Alfred - Prahran
Recruitment outside Australia
Country [1] 6681 0
Austria
State/province [1] 6681 0

Funding & Sponsors
Funding source category [1] 290788 0
Commercial sector/Industry
Name [1] 290788 0
Uptake Medical Corporation
Country [1] 290788 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Uptake Medical Corporation
Address
Uptake Medical Corporation
1173 Warner Ave.
Tustin, California, 92780
Country
United States of America
Secondary sponsor category [1] 289471 0
Commercial sector/Industry
Name [1] 289471 0
Aurora Bioscience Pty Ltd
Address [1] 289471 0
P.O Box 946
Baulkham Hills
NSW 2153
Country [1] 289471 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292418 0
The Alfred Hospital
Ethics committee address [1] 292418 0
Ethics committee country [1] 292418 0
Australia
Date submitted for ethics approval [1] 292418 0
28/08/2014
Approval date [1] 292418 0
06/10/2014
Ethics approval number [1] 292418 0
319/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55114 0
Prof Gregory Snell
Address 55114 0
The Alfred Hospital
Commercial Road
Prahran, VIC 3004
Country 55114 0
Australia
Phone 55114 0
+ 61 3 9076 2867
Fax 55114 0
+ 61 3 9076 3601
Email 55114 0
[email protected]
Contact person for public queries
Name 55115 0
Lynda Holsworth
Address 55115 0
The Alfred Hospital
Commercial Road
Prahran, VIC 3004
Country 55115 0
Australia
Phone 55115 0
+ 61 3 9076 2743
Fax 55115 0
+ 61 3 9076 3601
Email 55115 0
[email protected]
Contact person for scientific queries
Name 55116 0
Erik Henne
Address 55116 0
Uptake Medical Corporation
1173 Warner Ave.
Tustin, California, 92780
Country 55116 0
United States of America
Phone 55116 0
+ 1 949 379 8732
Fax 55116 0
Email 55116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial withdrawn - patients not enrolled


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.