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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction | Clinical Trials | Clareo Health

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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)

NCT02504424•AirXpanders, Inc.

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

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Yes

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).

Locations (8)

Marin General Hospital

Greenbrae, California, United States

Good Samaritan Hospital, San Jose

San Jose, California, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Faulkner Hospital

Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Columbia University

New York, New York, United States

Presbyterian Medical Center

Charlotte, North Carolina, United States

Key Dates

Start Date

November 12, 2015

Primary Completion Date

May 3, 2017

Completion Date

September 26, 2017

Last Updated

January 29, 2019

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

AeroForm Tissue Expander

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

Inclusion Criteria

Exclusion Criteria

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