Clinical trial NCT02504424: AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
Official title: AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Tissue Expansion
Tissue Expander
Breast Tissue Expansion
Breast Tissue Expander
Breast Reconstruction
2 Stage Breast Reconstruction
Lead sponsor: AirXpanders, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective, multi-center, single arm, open-label, continued access clinical study. Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event
timeFrame: 6 months
Secondary outcomes:
measure: Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.
timeFrame: 6 months
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Marin General Hospital
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital, San Jose
state: California
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Faulkner Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Charlotte
country: United States
facility: Presbyterian Medical Center
state: North Carolina
Study officials:
affiliation: AirXpanders Chief Medical Officer
name: Daniel Jacobs, M.D.
role: STUDY_CHAIR
affiliation: Columbia University
name: Jeffrey Ascherman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.