Breast CancerPACENCT01009008
Patient Activated Controlled Expansion (PACE) Trial
A study of Breast Cancer and Mastectomy, run by AirXpanders, Inc. at 1 site in Australia.
Trial summary
The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Mastectomy, Breast Reconstruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2009to Jun 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female between the ages of 18 and 65 years.
- Planned breast reconstruction surgery post-mastectomy.
- Able to provide informed consent.
- Able to understand protocol components.
Who cannot join
- Tissue at the intended expansion site is determined unsuitable by the surgeon (i.e., infection, compromised vascularity, history of compromised wound healing, mastectomy skin flaps of questionable viability, excessively tight skin envelope, previous radiation treatment, active ulceration)
- Residual gross tumor at the intended expansion site
- History of or planned adjuvant radiation therapy
- Co-morbid condition determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications.
- Obesity with BMI of 30 or above
- Current smoker
Show all 9Show fewer
- Psychologically unsuitable patient
- Patient unable to understand the protocol for tissue expansion
- Planned flight or assent to altitude exceeding 1000 meters above baseline during the expansion period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents.
Read the detailed description
Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the AirXpanders tissue expander in patients undergoing breast reconstruction surgery following mastectomy.
Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the first 5 patients, the sponsor will determine if additional subjects will be recruited to further evaluate treatment outcome.
Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s) should have the necessary qualifications and sufficient experience (minimum of 12 breast tissue expanders placed per year) to participate in the trial.
Duration of Patient Participation: Eligible patients will be enrolled over approximately 2 months.
Patients will be instructed on the tissue expansion protocol pre-operatively and undergo post-operative clinical follow-up on a weekly basis or more frequently if deemed necessary by the treating surgeon.
Each patient will be followed through removal of the tissue expander.
Study Population:
The study population will consist of up to 10 patients. Eligible patients are females between the ages of 18 and 65 years who are planning to undergo breast reconstruction surgery following mastectomy. Eligible patients must be able to provide informed consent and understand protocol components.
- Conditions
- Breast Cancer, Mastectomy, Breast Reconstruction
- Being tested
- Patient Activated Controlled Expansion Device
- Keywords
- cancer, breast cancer, mastectomy, breast reconstruction, reconstruction, tissue expansion, two-stage breast reconstruction, tissue expander, AeroForm, AirXpander
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Activated Controlled Expansion DeviceDevice
Patient activated controlled expansion for post-mastectomy breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Post-mastectomy | Experimental | Post-mastectomy patients undergoing expander reconstruction Receives: Device: Patient Activated Controlled Expansion Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expansion to and maintenance of clinically desired breast volume (not exceeding implant maximum) until permanent implant placement or 6 months (whichever comes first) unless prohibited by a non-device related failure.
Measured: 6 months
Secondary outcomes (4)
Safety as evidenced by a low incidence of device-related adverse events.
Measured: 6 months
Time required to achieve desired expansion results.
Measured: 6 months
Overall patient treatment satisfaction.
Measured: 6 months
Overall surgeon treatment satisfaction.
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 posted6 Nov 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AirXpanders, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Connell, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009008
- Sponsor's protocol ID
- CTP-0001
- Acronym
- PACE
- Status last verified
- Aug 2018
- First submitted
- 5 Nov 2009
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Connell TF. Patient-activated controlled expansion for breast reconstruction using controlled carbon dioxide inflation: confirmation of a feasibility study. Plast Reconstr Surg. 2014 Oct;134(4):503e-511e. doi: 10.1097/PRS.0000000000000551.
PubMed 25357043Connell AF. Patient-activated controlled expansion for breast reconstruction with controlled carbon dioxide inflation: a feasibility study. Plast Reconstr Surg. 2011 Oct;128(4):848-852. doi: 10.1097/PRS.0b013e3182268b80.
PubMed 21921761
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
- ClinicalTrials.gov ID
- NCT01009008
- Acronym / sponsor ID
- PACE / CTP-0001
- Conditions
- Breast Cancer, Mastectomy, Breast Reconstruction
- Keywords
- cancer, breast cancer, mastectomy, breast reconstruction, reconstruction, tissue expansion, two-stage breast reconstruction, tissue expander
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AirXpanders, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Nov 2009 (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.
The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents.
Detailed description
Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the AirXpanders tissue expander in patients undergoing breast reconstruction surgery following mastectomy.
Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the first 5 patients, the sponsor will determine if additional subjects will be recruited to further evaluate treatment outcome.
Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s) should have the necessary qualifications and sufficient experience (minimum of 12 breast tissue expanders placed per year) to participate in the trial.
Duration of Patient Participation: Eligible patients will be enrolled over approximately 2 months.
Patients will be instructed on the tissue expansion protocol pre-operatively and undergo post-operative clinical follow-up on a weekly basis or more frequently if deemed necessary by the treating surgeon.
Each patient will be followed through removal of the tissue expander.
Study Population:
The study population will consist of up to 10 patients. Eligible patients are females between the ages of 18 and 65 years who are planning to undergo breast reconstruction surgery following mastectomy. Eligible patients must be able to provide informed consent and understand protocol components.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-mastectomy | Experimental | Device: Patient Activated Controlled Expansion DevicePost-mastectomy patients undergoing expander reconstruction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female between the ages of 18 and 65 years.
- Planned breast reconstruction surgery post-mastectomy.
- Able to provide informed consent.
- Able to understand protocol components.
Key exclusion criteria (9 listed)
- Tissue at the intended expansion site is determined unsuitable by the surgeon (i.e., infection, compromised vascularity, history of compromised wound healing, mastectomy skin flaps of questionable viability, excessively tight skin envelope, previous radiation treatment, active ulceration)
- Residual gross tumor at the intended expansion site
- History of or planned adjuvant radiation therapy
- Co-morbid condition determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications.
- Obesity with BMI of 30 or above
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 |
|---|---|---|
| Patient Activated Controlled Expansion DevicePatient activated controlled expansion for post-mastectomy breast reconstruction | Device | Post-mastectomy |
Primary outcome
Expansion to and maintenance of clinically desired breast volume (not exceeding implant maximum) until permanent implant placement or 6 months (whichever comes first) unless prohibited by a non-device related failure.
Time frame: 6 months
4 secondary outcomes
Safety as evidenced by a low incidence of device-related adverse events.
Time frame: 6 months
Time required to achieve desired expansion results.
Time frame: 6 months
Overall patient treatment satisfaction.
Time frame: 6 months
Overall surgeon treatment satisfaction.
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 10 Aug 2018.
- Derived from this study: PubMed 25357043Connell TF. Patient-activated controlled expansion for breast reconstruction using controlled carbon dioxide inflation: confirmation of a feasibility study. Plast Reconstr Surg. 2014 Oct;134(4):503e-511e. doi: 10.1097/PRS.0000000000000551.
- Derived from this study: PubMed 21921761Connell AF. Patient-activated controlled expansion for breast reconstruction with controlled carbon dioxide inflation: a feasibility study. Plast Reconstr Surg. 2011 Oct;128(4):848-852. doi: 10.1097/PRS.0b013e3182268b80.
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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.
Anthony Connell, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Breast Cancer and Mastectomy, 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 4 inclusion and 9 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 10 Aug 2018. 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?
Expansion to and maintenance of clinically desired breast volume (not exceeding implant maximum) until permanent implant placement or 6 months (whichever comes first) unless prohibited by a non-device related failure. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01009008, which also lists 2 linked publications.
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 10 Aug 2018.