Clinical trial NCT01425268: Patient Controlled Tissue Expansion for Breast Reconstruction
Official title: AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Tissue Expansion
Tissue Expander
Breast Tissue Expansion
Breast Tissue Expander
Breast Reconstruction
Two Stage Breast Reconstruction
2 Stage Breast Reconstruction
Lead sponsor: AirXpanders, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).

Eligibility criteria: Inclusion Criteria:

1. Subject is a woman between the ages of 18-70.
2. Subject needs to have tissue expansion as part of her breast reconstruction.
3. Subject is able to provide written informed consent.
4. Subject is able and willing to comply with all of the study requirements.
5. Subject is able to understand and manage at home dosing regimen.

Exclusion Criteria:

1. Subjects skin is not suitable for tissue expansion.
2. Subject has remaining tumor cells following her mastectomy.
3. Subject has a current or prior infection at the intended expansion site.
4. Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.

4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.

5. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.

6. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).

7. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).

8. Subject is currently participating in a concurrent investigational drug or device study.

9. Subject is a current tobacco smoker. 10. Subject is overweight (BMI \> 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not \> 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.

12. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.

13. Subject is pregnant or planning on becoming pregnant during the study period.

14. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.

Primary outcomes:
measure: Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event
timeFrame: 12 months
Secondary outcomes:
measure: Expansion Days
timeFrame: 12 months
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Marin General Hospital
state: California
city: Los Angeles
country: United States
facility: Susan Downey
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Healthcare-Sacramento
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital, San Jose
state: California
city: Fort Lauderdale
country: United States
facility: eSSe Plastic Surgery
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center South
state: Florida
city: Louisville
country: United States
facility: Norton Healthcare Pavilion
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Faulkner Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
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: Oceanside
country: United States
facility: South Nassau Communities Hospital
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: New York-Presbyterian Hospital / Columbia University
name: Jeffrey A. Ascherman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ascherman JA, Zeidler K, Morrison KA, Appel JZ, Berkowitz RL, Castle J, Colwell A, Chun Y, Johnson D, Mohebali K. Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial. Plast Reconstr Surg. 2016 Dec;138(6):1161-1170. doi: 10.1097/PRS.0000000000002784.
citation: Zeidler KR, Berkowitz RL, Chun YS, Alizadeh K, Castle J, Colwell AS, Desai AR, Evans G, Hollenbeck S, Johnson DJ, Morris D, Ascherman JA. AeroForm patient controlled tissue expansion and saline tissue expansion for breast reconstruction: a randomized controlled trial. Ann Plast Surg. 2014 May;72 Suppl 1:S51-5. doi: 10.1097/SAP.0000000000000175.