Trial Outcomes & Findings for AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (NCT NCT02504424)

NCT ID: NCT02504424

Last Updated: 2019-01-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-01-29

Participant Flow

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.

Participant milestones

Measure	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 gas from an internal reservoir to fill and inflate the expander.
Overall Study STARTED	50
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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 gas from an internal reservoir to fill and inflate the expander.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

Baseline characteristics by cohort

Measure	AeroForm Tissue Expander n=50 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Body Mass Index	24.5 lbs/in^2 STANDARD_DEVIATION 3.57 • n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	AeroForm Tissue Expander n=80 breasts 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.
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

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Measure	AeroForm Tissue Expander n=84 breasts 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.
Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.	80 breasts

Adverse Events

AeroForm Tissue Expander

Serious events: 11 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	AeroForm Tissue Expander n=50 participants at risk 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.
Reproductive system and breast disorders cellulitis	8.0% 4/50 • Number of events 4 • 1 year 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.
Reproductive system and breast disorders wound dehiscence	2.0% 1/50 • Number of events 1 • 1 year 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.
Reproductive system and breast disorders hematoma	2.0% 1/50 • Number of events 1 • 1 year 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.
Reproductive system and breast disorders seroma	2.0% 1/50 • Number of events 1 • 1 year 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.
Immune system disorders neutropenic fever, weakness	2.0% 1/50 • Number of events 1 • 1 year 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.
Reproductive system and breast disorders inflammation (red breast syndrome)	4.0% 2/50 • Number of events 2 • 1 year 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.
Renal and urinary disorders urinary tract infection	2.0% 1/50 • Number of events 1 • 1 year 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.

Other adverse events

Measure	AeroForm Tissue Expander n=50 participants at risk 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.
Skin and subcutaneous tissue disorders erythema	10.0% 5/50 • Number of events 5 • 1 year 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.
Reproductive system and breast disorders seroma	6.0% 3/50 • Number of events 3 • 1 year 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.

Additional Information

Director of Clinical Affairs

AirXpanders

Phone: 650-390-9000

Email: kkelley@airxpanders.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place