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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AeroForm Tissue Expansion | Experimental | AeroForm Tissue Expansion inflation with carbon dioxide by remote control |
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| Saline Tissue Expansion | Active Comparator | Saline Tissue Expansion inflated by needle injections of saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AeroForm Tissue Expansion | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expansion Days | The median number of days taken to complete the expansion process. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey A. Ascherman, M.D. | New York-Presbyterian Hospital / Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marin General Hospital | Greenbrae | California | 94904 | United States | ||
| Susan Downey |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27879582 | Background | Ascherman JA, Zeidler K, Morrison KA, Appel JZ, Berkowitz RL, Castle J, Colwell A, Chun Y, Johnson D, Mohebali K. Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial. Plast Reconstr Surg. 2016 Dec;138(6):1161-1170. doi: 10.1097/PRS.0000000000002784. | |
| 24740025 |
| Label | URL |
|---|---|
| AirXpanders | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Saline Tissue Expansion | Procedure | 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. |
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| Los Angeles |
| California |
| 90004 |
| United States |
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| Sutter Healthcare-Sacramento | Sacramento | California | 95825 | United States |
| Good Samaritan Hospital, San Jose | San Jose | California | 95008 | United States |
| eSSe Plastic Surgery | Fort Lauderdale | Florida | 33308 | United States |
| Baptist Medical Center South | Jacksonville | Florida | 32258 | United States |
| Norton Healthcare Pavilion | Louisville | Kentucky | 40202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Faulkner Hospital | Boston | Massachusetts | 02130 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01605 | United States |
| Columbia University | New York | New York | 10032-3713 | United States |
| South Nassau Communities Hospital | Oceanside | New York | 11572 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28207 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Zeidler KR, Berkowitz RL, Chun YS, Alizadeh K, Castle J, Colwell AS, Desai AR, Evans G, Hollenbeck S, Johnson DJ, Morris D, Ascherman JA. AeroForm patient controlled tissue expansion and saline tissue expansion for breast reconstruction: a randomized controlled trial. Ann Plast Surg. 2014 May;72 Suppl 1:S51-5. doi: 10.1097/SAP.0000000000000175. |
| FG001 |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Units | Breasts | 12 months | Breasts | Breasts |
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| Secondary | Expansion Days | The median number of days taken to complete the expansion process. | All breasts successfully exchange from expander to standard breast implant were analyzed for the length of time to complete the expansion process (days) | Posted | Median | Full Range | days | 12 months | breasts | breasts |
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1 year
All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99).
AEs assessed by investigators for severity, seriousness and relationship to device or procedure.
AEs coded to MedDRA standardized terms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 99 | 21 | 99 | 46 | 99 |
| EG001 | 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. | 0 | 52 | 7 | 52 | 22 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma, Breast | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | Post operative hematoma with return to the OR |
|
| Stroke, Mild | Nervous system disorders | MedDRA (14.1) | Systematic Assessment | Mild Stroke, Admitted Overnight |
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| Neutropenic Fever | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment | Fever with low wbc associated with chemotherapy |
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| Red Breast Syndrome | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment | Inflammation of the breast tissue |
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| Seroma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | Seroma with needle guided aspiration |
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| Extrusion | General disorders | MedDRA (14.1) | Systematic Assessment | Device extrusion through skin |
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| Hematoma, Chest VAP Site | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | Hematoma after removal of Venous Access Port |
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| Cellulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment | Superficial Cellulitis of Breast |
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| Wound Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment | Wound Infection at the Surgical Site |
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| Delayed Wound Healing | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | Delayed wound healing, tissue necrosis |
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| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | Dehiscence (Separation) of the Incision |
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| Erosion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | Erosion of the skin overlying the expander |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment | Post operative pneumothorax |
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| Deflation | General disorders | MedDRA (14.1) | Systematic Assessment | Deflation |
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| Under-Expansion | General disorders | MedDRA (14.1) | Systematic Assessment | Under-Expansion |
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| Over-Expansion | Product Issues | MedDRA (14.1) | Systematic Assessment | Over-Expansion |
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| Exposure | General disorders | MedDRA (14.1) | Systematic Assessment | Exposed Tissue Expander |
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| Muscle Disruption | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | Disruption of Alloderm-Muscle Interface |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA (14.1) | Systematic Assessment | Subject Reported Pain |
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| Delayed Wound Healing | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | Delayed Wound Healing / Tissue Necrosis, |
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| Seroma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | Seroma, Breast |
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| Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment | Post Op Wound Infection / Cellulitis |
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Device improvements occurred during the study with later subjects completing the study with a revised version of the device.
Results include all subjects treated in the study, regardless of device version.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | AirXpanders | 650-390-9000 | 9003 | kkelley@airxpanders.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015625 | Tissue Expansion Devices |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
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| >=65 years |
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| Male |
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Assuming that the success rate for both expanders was 95%, at least 92 breasts implanted with a AeroForm Tissue Expander and 46 breasts implanted with a saline expander were needed to be 80% confident (i.e., have a statistical power of 80%) that the lower bound of the one-sided 95% Confidence Interval for the difference in the Success rates (πTreatment - πControl) was greater than or equal to -10%.
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