Breast Cancer
Conditions
Keywords
Tissue Expansion, Tissue Expander, Breast Tissue Expansion, Breast Tissue Expander, Breast Reconstruction, Two Stage Breast Reconstruction, 2 Stage Breast Reconstruction
Brief summary
This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.
Detailed description
This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).
Interventions
DEVICEAeroForm Tissue Expansion
The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.
PROCEDURESaline Tissue Expansion
A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Sponsors
AirXpanders, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject is a woman between the ages of 18-70. 2. Subject needs to have tissue expansion as part of her breast reconstruction. 3. Subject is able to provide written informed consent. 4. Subject is able and willing to comply with all of the study requirements. 5. Subject is able to understand and manage at home dosing regimen.
Exclusion criteria
1. Subjects skin is not suitable for tissue expansion. 2. Subject has remaining tumor cells following her mastectomy. 3. Subject has a current or prior infection at the intended expansion site. 4. Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used. 4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted. 5\. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site. 6\. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes). 7\. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin). 8\. Subject is currently participating in a concurrent investigational drug or device study. 9\. Subject is a current tobacco smoker. 10. Subject is overweight (BMI \> 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not \> 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted. 12\. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device. 13\. Subject is pregnant or planning on becoming pregnant during the study period. 14\. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event | 12 months | The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expansion Days | 12 months | The median number of days taken to complete the expansion process. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited were current patients at the investigator's practice who were scheduled to undergo two-stage breast reconstruction between November 2011 - December 2014.
Participants by arm
| Arm | Count |
|---|---|
| AeroForm Tissue Expansion AeroForm Tissue Expansion inflation with carbon dioxide by remote control
AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander. | 98 |
| Saline Tissue Expansion Saline Tissue Expansion inflated by needle injections of saline
Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline. | 52 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Sponsor Decision | 5 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Saline Tissue Expansion | AeroForm Tissue Expansion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 92 Participants | 141 Participants |
| Age, Continuous | 51.1 years STANDARD_DEVIATION 9.88 | 48.9 years STANDARD_DEVIATION 9.83 | 49.7 years STANDARD_DEVIATION 9.87 |
| Region of Enrollment United States | 52 participants | 98 participants | 150 participants |
| Sex: Female, Male Female | 52 Participants | 98 Participants | 150 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 52 |
| other Total, other adverse events | 46 / 99 | 22 / 52 |
| serious Total, serious adverse events | 21 / 99 | 7 / 52 |
Outcome results
Primary
Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event
The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.
Time frame: 12 months
Population: Primary Analysis Population (Per Protocol Cohort) = Subjects with an expander implanted successfully with no major protocol violation (evaluated per breast). Subjects who had a bilateral procedure have each breast evaluated separately.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| AeroForm Tissue Expansion | Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event | 149 Breasts |
| Saline Tissue Expansion | Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event | 82 Breasts |
Comparison: The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 \< πTreatment - πControl).
Secondary
Expansion Days
The median number of days taken to complete the expansion process.
Time frame: 12 months
Population: All breasts successfully exchange from expander to standard breast implant were analyzed for the length of time to complete the expansion process (days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AeroForm Tissue Expansion | Expansion Days | 21 days |
| Saline Tissue Expansion | Expansion Days | 46 days |
p-value: <0.0001Kaplan-Meier Log Rank test