Study of AeroForm Tissue Expander for Breast Reconstruction | NCT01903174

Studies
Study of AeroForm Tissue Expander for Breast Reconstruction

NCT01903174

Sponsor

AirXpanders, Inc.

Status

Completed

Last Update Posted

Mar 26, 2014Estimated

Enrollment

21Actual

Phase

Not Applicable

Conditions

Breast Cancer
Breast Reconstruction

Interventions

AeroForm Breast Tissue Expander

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 16, 2013

First Submission Date that Met QC Criteria

Jul 16, 2013

First Posted Date

Jul 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2014

Last Update Posted Date

Mar 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Label	Type	Description	Intervention Names
AeroForm Tissue Expansion	Experimental	AeroForm Breast Tissue Expander placed after mastectomy	Device: AeroForm Breast Tissue Expander

Name	Type	Description	Arm Group Labels	Other Names
AeroForm Breast Tissue Expander	Device	Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide	AeroForm Tissue Expansion

Measure	Description	Time Frame
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event		6 months

Measure	Description	Time Frame
Adverse Events related to the Breast Reconstruction Procedure		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

-

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases