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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02504424
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : September 5, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Device: AeroForm Tissue Expander
Enrollment 50
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.
Pre-assignment Details  
Arm/Group Title AeroForm Tissue Expander
Hide Arm/Group Description

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 gas from an internal reservoir to fill and inflate the expander.
Period Title: Overall Study
Started 50
Completed 48
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title AeroForm Tissue Expander
Hide Arm/Group Description

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.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
50 Subjects treated under protocol
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
47
  94.0%
>=65 years
3
   6.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
50
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
8
  16.0%
Not Hispanic or Latino
42
  84.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   6.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   4.0%
White
40
  80.0%
More than one race
1
   2.0%
Unknown or Not Reported
4
   8.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Lbs/in^2
Number Analyzed 50 participants
24.5  (3.57)
1.Primary Outcome
Title Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
  • 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/Group Title AeroForm Tissue Expander
Hide Arm/Group Description:

AeroForm Tissue Expansion inflation with carbon dioxide 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.
Overall Number of Participants Analyzed 48
Overall Number of Units Analyzed
Type of Units Analyzed: Breasts
 80
Count of Units
Unit of Measure: breasts
80
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AeroForm Tissue Expander
Comments 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).
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent of breasts successfully exchange
Estimated Value 100
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AeroForm Tissue Expander
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter % breasts successfully exchanged
Estimated Value 100
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title AeroForm Tissue Expander
Hide Arm/Group Description:

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 gas from an internal reservoir to fill and inflate the expander.
Overall Number of Participants Analyzed 49
Overall Number of Units Analyzed
Type of Units Analyzed: Breasts
 84
Count of Units
Unit of Measure: breasts
80
  95.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AeroForm Tissue Expander
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter % breasts successfully exchanged
Estimated Value 95.2
Estimation Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description

The safety of the device is evaluated by:

  • Device related adverse events
  • All adverse events, regardless of whether serious or there is a causal relationship to the device.
  • Serious device related adverse events
  • All serious adverse events, regardless of whether there is a causal relationship to the device.
  • Device malfunctions leading to expander removal and/or replacement.
 
Arm/Group Title AeroForm Tissue Expander
Hide Arm/Group Description

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 gas from an internal reservoir to fill and inflate the expander.
All-Cause Mortality
AeroForm Tissue Expander
Affected / at Risk (%)
Total   0/50 (0.00%)    
Hide Serious Adverse Events
AeroForm Tissue Expander
Affected / at Risk (%) # Events
Total   11/50 (22.00%)    
Immune system disorders   
neutropenic fever, weakness † 1  1/50 (2.00%)  1
Renal and urinary disorders   
urinary tract infection † 1  1/50 (2.00%)  1
Reproductive system and breast disorders   
cellulitis † 1  4/50 (8.00%)  4
wound dehiscence † 1  1/50 (2.00%)  1
hematoma † 1  1/50 (2.00%)  1
seroma † 1  1/50 (2.00%)  1
inflammation (red breast syndrome) † 1  2/50 (4.00%)  2
1
Term from vocabulary, MedDRA (18.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AeroForm Tissue Expander
Affected / at Risk (%) # Events
Total   8/50 (16.00%)    
Reproductive system and breast disorders   
seroma † 1  3/50 (6.00%)  3
Skin and subcutaneous tissue disorders   
erythema † 1  5/50 (10.00%)  5
1
Term from vocabulary, MedDRA (18.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Affairs
Organization: AirXpanders
Phone: 650-390-9000
EMail: kkelley@airxpanders.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AirXpanders, Inc.
ClinicalTrials.gov Identifier: NCT02504424    
Other Study ID Numbers: CTP-0005 AirXpanders
First Submitted: July 20, 2015
First Posted: July 22, 2015
Results First Submitted: August 8, 2018
Results First Posted: September 5, 2018
Last Update Posted: January 29, 2019