AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
XPAND-II
1 other identifier
interventional
50
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Nov 2015
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedStudy Start
First participant enrolled
November 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2017
CompletedResults Posted
Study results publicly available
September 5, 2018
CompletedJanuary 29, 2019
January 1, 2019
1.5 years
July 20, 2015
August 8, 2018
January 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.
6 months
Study Arms (1)
AeroForm Tissue Expander
EXPERIMENTALAeroForm Tissue Expansion inflation with carbon dioxide by remote control
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Marin General Hospital
Greenbrae, California, 94904, United States
Good Samaritan Hospital, San Jose
San Jose, California, 95008, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Faulkner Hospital
Boston, Massachusetts, 02130, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605, United States
Columbia University
New York, New York, 10032-3713, United States
Presbyterian Medical Center
Charlotte, North Carolina, 28207, United States
Related Publications (1)
Ascherman JA, Zeidler K, Morrison KA, Appel J, Castle J, Chun Y, Colwell A, Mohebali K, Stokes T, Sudarsky L. Results of XPAND II: A Multicenter, Prospective, Continued-Access Clinical Trial Using the AeroForm Tissue Expander for Two-Stage Breast Reconstruction. Plast Reconstr Surg. 2020 Jan;145(1):21e-29e. doi: 10.1097/PRS.0000000000006395.
PMID: 31881599DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Affairs
- Organization
- AirXpanders
Study Officials
- STUDY CHAIR
Daniel Jacobs, M.D.
AirXpanders Chief Medical Officer
- PRINCIPAL INVESTIGATOR
Jeffrey Ascherman, M.D.
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 22, 2015
Study Start
November 12, 2015
Primary Completion
May 3, 2017
Study Completion
September 26, 2017
Last Updated
January 29, 2019
Results First Posted
September 5, 2018
Record last verified: 2019-01