Study of AeroForm Tissue Expander for Breast Reconstruction

NCT01903174 | Completed DMC

• 1 other identifier: CTP-0004
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction

Conditions

Breast Cancer; Breast Reconstruction

Keywords

Breast Cancer; Breast Reconstruction; Breast Tissue Expansion; Breast Tissue Expander; Two Stage Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event

  6 months

Secondary Outcomes (1)

• Adverse Events related to the Breast Reconstruction Procedure

  6 months

Study Arms (1)

AeroForm Tissue Expansion

EXPERIMENTAL

AeroForm Breast Tissue Expander placed after mastectomy

Device: AeroForm Breast Tissue Expander

Interventions

AeroForm Breast Tissue Expander DEVICE

Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide

Also known as: AeroForm, AeroForm Tissue Expander, AirXpander, AirXpander Tissue Expander, AirXpanders Breast Tissue Expander

AeroForm Tissue Expansion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is female between the ages of 18 - 70.
• Subject has elected two stage breast reconstruction with tissue expanders.
• Subject's tissue is amenable to tissue expansion.
• 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 has residual gross malignancy following mastectomy.
• Subject has a current infection at the intended expansion site.
• Subject has clinically significant radiation fibrosis at the expansion site.
• Subject has planned radiation at the intended expansion site during the time the expander is implanted.
• 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 currently participating in a concurrent investigational drug or device study.
• Subject is a current tobacco smoker.
• Subject is overweight with a BMI \> 33.
• Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
• Subject is pregnant or planning to become pregnant during the study period.
• Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.

Sponsors & Collaborators

• AirXpanders, Inc.: lead

Study Sites (1)

Mount Hospital

Subiaco, Western Australia, 6008, Australia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tony Connell, F.R.A.C.S.

  Mount Hospital

  PRINCIPAL INVESTIGATOR

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 16, 2013
• First Posted: July 19, 2013
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

AU (1)