Patient Controlled Tissue Expansion for Breast Reconstruction

NACompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Breast Cancer
Interventions
DEVICE

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.

PROCEDURE

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.

Trial Locations (17)

11572

South Nassau Communities Hospital, Oceanside

27705

Duke University Medical Center, Durham

28207

Novant Health Presbyterian Medical Center, Charlotte

32258

Baptist Medical Center South, Jacksonville

33308

eSSe Plastic Surgery, Fort Lauderdale

40202

Norton Healthcare Pavilion, Louisville

77030

The Methodist Hospital, Houston

90004

Susan Downey, Los Angeles

92868

University of California, Irvine Medical Center, Orange

94904

Marin General Hospital, Greenbrae

95008

Good Samaritan Hospital, San Jose, San Jose

95825

Sutter Healthcare-Sacramento, Sacramento

02114

Massachusetts General Hospital, Boston

02130

Faulkner Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01605

University of Massachusetts Memorial Medical Center, Worcester

10032-3713

Columbia University, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AirXpanders, Inc.

INDUSTRY

NCT01425268 - Patient Controlled Tissue Expansion for Breast Reconstruction | Biotech Hunter | Biotech Hunter