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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01903174




Registration number
NCT01903174
Ethics application status
Date submitted
16/07/2013
Date registered
19/07/2013
Date last updated
26/03/2014

Titles & IDs
Public title
Study of AeroForm Tissue Expander for Breast Reconstruction
Scientific title
AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction
Secondary ID [1] 0 0
CTP-0004
Universal Trial Number (UTN)
Trial acronym
ASPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Breast Reconstruction 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - AeroForm Breast Tissue Expander

Experimental: AeroForm Tissue Expansion - AeroForm Breast Tissue Expander placed after mastectomy


Treatment: Devices: AeroForm Breast Tissue Expander
Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Adverse Events related to the Breast Reconstruction Procedure
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
1. Subject is female between the ages of 18 - 70.

2. Subject has elected two stage breast reconstruction with tissue expanders.

3. Subject's tissue is amenable to tissue expansion.

4. Subject is able to provide written informed consent.

5. Subject is able and willing to comply with all of the study requirements.

6. Subject has the physical, perceptual and cognitive capacity to understand and manage
the at home dosing regimen.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has residual gross malignancy following mastectomy.

2. Subject has a current infection at the intended expansion site.

3. Subject has clinically significant radiation fibrosis at the expansion site.

4. Subject has planned radiation at the intended expansion site during the time the
expander is implanted.

5. Subject has any co-morbid condition determined by the Investigator to place the
subject at an increased risk of complications (e.g., severe collagen vascular disease,
poorly managed diabetes).

6. Subject is currently participating in a concurrent investigational drug or device
study.

7. Subject is a current tobacco smoker.

8. Subject is overweight with a BMI > 33.

9. Subject has currently implanted electronic device such as a pacemaker, defibrillator,
neurostimulator device, or drug infusion device.

10. Subject is pregnant or planning to become pregnant during the study period.

11. Subject has a history of psychological condition, drug or alcohol misuse which may
interfere with their ability to use the device safely.

-

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Mount Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AirXpanders, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is intended to support previous positive results of the AeroForm™ Patient
Controlled Tissue Expander System for breast reconstruction
Trial website
https://clinicaltrials.gov/ct2/show/NCT01903174
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tony Connell, F.R.A.C.S.
Address 0 0
Mount Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries