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Completed Not applicable Interventional Accepts healthy volunteers Results available

Patient Controlled Tissue Expansion for Breast Reconstruction

ClinicalTrials.gov ID: NCT01425268

Public ClinicalTrials.gov record NCT01425268. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 3:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01425268
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
AirXpanders, Inc.
Industry
Enrollment
158 participants

Conditions and interventions

Conditions

Interventions

Device · Procedure

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2011 (Type not available)
Primary completion
Aug 2015 (Actual)
Completion
Aug 2015 (Actual)
Last update posted
Jun 27, 2017

2011 – 2015

United States locations

U.S. sites
17
U.S. states
7
U.S. cities
15
Facility City State ZIP Site status
Marin General Hospital Greenbrae California 94904 —
Susan Downey Los Angeles California 90004 —
University of California, Irvine Medical Center Orange California 92868 —
Sutter Healthcare-Sacramento Sacramento California 95825 —
Good Samaritan Hospital, San Jose San Jose California 95008 —
eSSe Plastic Surgery Fort Lauderdale Florida 33308 —
Baptist Medical Center South Jacksonville Florida 32258 —
Norton Healthcare Pavilion Louisville Kentucky 40202 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Faulkner Hospital Boston Massachusetts 02130 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01605 —
Columbia University New York New York 10032-3713 —
South Nassau Communities Hospital Oceanside New York 11572 —
Novant Health Presbyterian Medical Center Charlotte North Carolina 28207 —
Duke University Medical Center Durham North Carolina 27705 —
The Methodist Hospital Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01425268, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 27, 2017 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01425268 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →