Breast CancerASPIRENCT01903174
Study of AeroForm Tissue Expander for Breast Reconstruction
A study testing AeroForm Breast Tissue Expander in people with Breast Cancer and Breast Reconstruction, run by AirXpanders, Inc. at 1 site in Australia.
Trial summary
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Breast Reconstruction
- What is being tested?
- AeroForm Breast Tissue Expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is female between the ages of 18 - 70.
- Subject has elected two stage breast reconstruction with tissue expanders.
- Subject's tissue is amenable to tissue expansion.
- Subject is able to provide written informed consent.
- Subject is able and willing to comply with all of the study requirements.
- Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen.
Who cannot join
- Subject has residual gross malignancy following mastectomy.
- Subject has a current infection at the intended expansion site.
- Subject has clinically significant radiation fibrosis at the expansion site.
- Subject has planned radiation at the intended expansion site during the time the expander is implanted.
- 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).
- Subject is currently participating in a concurrent investigational drug or device study.
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- Subject is a current tobacco smoker.
- Subject is overweight with a BMI > 33.
- Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
- Subject is pregnant or planning to become pregnant during the study period.
- Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
Read the detailed description
The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria
- Conditions
- Breast Cancer, Breast Reconstruction
- Being tested
- AeroForm Breast Tissue Expander
- Keywords
- Breast Cancer, Breast Reconstruction, Breast Tissue Expansion, Breast Tissue Expander, Two Stage Breast Reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeroForm Breast Tissue ExpanderDevice
Also called AeroForm, AeroForm Tissue Expander, AirXpander, AirXpander Tissue Expander
Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide
| Study group | Role | What they receive |
|---|---|---|
| AeroForm Tissue Expansion | Experimental | AeroForm Breast Tissue Expander placed after mastectomy Receives: Device: AeroForm Breast Tissue Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event
Measured: 6 months
Secondary outcomes (1)
Adverse Events related to the Breast Reconstruction Procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AirXpanders, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Connell, F.R.A.C.S., Principal investigator, Mount Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903174
- Sponsor's protocol ID
- CTP-0004
- Acronym
- ASPIRE
- Status last verified
- Mar 2014
- First submitted
- 16 Jul 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction
- ClinicalTrials.gov ID
- NCT01903174
- Acronym / sponsor ID
- ASPIRE / CTP-0004
- Conditions
- Breast Cancer, Breast Reconstruction
- Keywords
- Breast Cancer, Breast Reconstruction, Breast Tissue Expansion, Breast Tissue Expander, Two Stage Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AirXpanders, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
Detailed description
The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AeroForm Tissue Expansion | Experimental | Device: AeroForm Breast Tissue ExpanderAeroForm Breast Tissue Expander placed after mastectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is female between the ages of 18 - 70.
- Subject has elected two stage breast reconstruction with tissue expanders.
- Subject's tissue is amenable to tissue expansion.
- Subject is able to provide written informed consent.
- Subject is able and willing to comply with all of the study requirements.
Key exclusion criteria (12 listed)
- Subject has residual gross malignancy following mastectomy.
- Subject has a current infection at the intended expansion site.
- Subject has clinically significant radiation fibrosis at the expansion site.
- Subject has planned radiation at the intended expansion site during the time the expander is implanted.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AeroForm Breast Tissue ExpanderAlso: AeroForm, AeroForm Tissue Expander, AirXpander, AirXpander Tissue ExpanderBreast Tissue Expander using a remote control to fill the expander with Carbon Dioxide | Device | AeroForm Tissue Expansion |
Primary outcome
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event
Time frame: 6 months
1 secondary outcome
Adverse Events related to the Breast Reconstruction Procedure
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- AirXpanders Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Connell, F.R.A.C.S. principal investigator
Mount Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AeroForm Breast Tissue Expander in people with Breast Cancer and Breast Reconstruction, run by AirXpanders, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.