CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 158 enrolled
Drug / intervention
AeroForm Tissue Expansion +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01425268
NCT01425268N/ACompleted
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AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

AirXpanders, Inc.·interventional·Posted Aug 30, 2011·Updated Jun 27, 2017

In Brief

A clinical study evaluating AeroForm Tissue Expansion and Saline Tissue Expansion for Breast Cancer. Completed, enrolled 158 participants across 17 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2011
Enrollment StartOct 1, 2011
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.8 years ago

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.