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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

NCT02504424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-01-29

Study results available
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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.

Conditions

Interventions

DEVICE

AeroForm Tissue Expander

The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.

Sponsors & Collaborators

  • AirXpanders, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Jacobs, M.D. · AirXpanders Chief Medical Officer

  • Jeffrey Ascherman, M.D. · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-12
Primary Completion
2017-05-03
Completion
2017-09-26

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504424 on ClinicalTrials.gov