At a glance
ClinicalIndex Comparison RecordN/ACompleted· 50 enrolled
Drug / intervention
AeroForm Tissue Expanderdevice
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.
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)
In Brief
A clinical study evaluating AeroForm Tissue Expander for Breast Cancer. Completed, enrolled 50 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartNov 2015
Primary CompletionMay 2017
Study CompletionSep 2017
TodayJul 2026
First PostedJul 22, 2015
Enrollment StartNov 12, 2015
Primary CompletionMay 3, 2017
Study CompletionSep 26, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.9 years ago
Interventions
AeroForm Tissue Expanderdevice
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.