Breast Cancer
Conditions
Keywords
Tissue Expansion, Tissue Expander, Breast Tissue Expansion, Breast Tissue Expander, Breast Reconstruction, 2 Stage Breast Reconstruction
Brief summary
This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.
Detailed description
This is a prospective, multi-center, single arm, open-label, continued access clinical study. Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s).
Interventions
DEVICEAeroForm Tissue Expander
The AeroForm 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.
Sponsors
AirXpanders, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is female between the ages of 18-70 * Subject requires tissue expansion as part of breast reconstruction * 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
Exclusion criteria
* Subject's tissue integrity is unsuitable for tissue expansion * Subject has residual gross malignancy at the intended expansion site * Subject has current or prior infection at the intended expansion site * Subject has a history of failed tissue expansion or breast reconstruction * 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 taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event | 6 months | The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort. | 6 months | Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in the analyses due to not completing the second stage surgery and withdrawal of consent. |
Countries
United States
Participant flow
Recruitment details
This study recruited women who were planning to have immediate or delayed breast reconstruction (unilateral or bilateral) post-mastectomy and required tissue expansion to develop tissue coverage for placement of standard breast implant(s). Subjects were identified from the medical practice of the participating investigators.
Participants by arm
| Arm | Count |
|---|---|
| AeroForm Tissue Expander AeroForm Tissue Expansion inflation with carbon dioxide gas by remote control
AeroForm Tissue Expander: The AeroForm 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. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | AeroForm Tissue Expander |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants |
| Body Mass Index | 24.5 lbs/in^2 STANDARD_DEVIATION 3.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 8 / 50 |
| serious Total, serious adverse events | 11 / 50 |
Outcome results
Primary
Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event
The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.
Time frame: 6 months
Population: * of participants is 48: # treated (50) minus participant failed exchange of both breasts for non-device related reason (1) and participant not analyzed due to withdrawal (1).~* of breasts is 80: # breasts treated (86) minus # breasts failed exchanged due to non-device related reason (4) and # breasts not analyzable due to withdrawal (2).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| AeroForm Tissue Expander | Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event | 80 breasts |
Comparison: Treatment Success includes all breasts which were exchanged successfully in the Per Protocol Cohort, excluding non-device related failures. The Treatment Success Rate per breast is 100% (80/80). Note: Denominator = 80 (86 implanted breasts - 6 breasts). Failed exchange = 4 breasts (non-device related) \& Missing = 2 breasts (patient non-compliant w/study and withdrew consent after treatment).
Comparison: Sensitivity Analysis (Best / Worst Case): Treatment Success by subject for the Per Protocol cohort includes all failures (excluding non-device related failures). The best case analysis considers success if the subject has at least one breast successfully reconstructed, and the worst case analysis considers it a failure if at least one breast has failed. The treatment success by subject is 100% for both best and worst case analysis.
Secondary
Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.
Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in the analyses due to not completing the second stage surgery and withdrawal of consent.
Time frame: 6 months
Population: Analysis population includes all treated breasts with the exception of 2 breasts that were not exchanged at the time of study completion (subject withdrew from study)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| AeroForm Tissue Expander | Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort. | 80 breasts |
Comparison: Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in analysis as subject withdrew from the study prior to exchange of her expanders.