AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

Breast Cancer Clinical Trial

— XPAND-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504424
• Other study ID #: CTP-0005 AirXpanders
• Status: Completed
• Phase: N/A
• Start date: November 12, 2015
• Est. completion date: September 26, 2017

Study information

• Verified date: January 2019
• Source: AirXpanders, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 26, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Faulkner Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Presbyterian Medical Center	Charlotte	North Carolina
United States	Broward Health Medical Center	Fort Lauderdale	Florida
United States	Marin General Hospital	Greenbrae	California
United States	Columbia University	New York	New York
United States	Good Samaritan Hospital, San Jose	San Jose	California
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AirXpanders, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months
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.	6 months