Patient Controlled Tissue Expansion for Breast Reconstruction

AirXpanders, Inc.158 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

Breast Cancer

Interventions

AeroForm Tissue ExpansionDEVICE

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.

Saline Tissue ExpansionPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (17)

Marin General Hospital

Greenbrae, California, United States

Susan Downey

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Expansion Days

The median number of days taken to complete the expansion process.

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.