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Trial record 1 of 4 for:    airxpanders
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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND II)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02504424
First Posted: July 22, 2015
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AirXpanders, Inc.
  Purpose
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.

Condition Intervention
Breast Cancer Device: AeroForm Tissue Expander

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND II)

Resource links provided by NLM:


Further study details as provided by AirXpanders, Inc.:

Primary Outcome Measures:
  • Successful tissue expansion with exchange to a permanent breast implant unless exchange is precluded by a non-device related event. [ Time Frame: 6 months ]
    The primary endpoint will be analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction will be counted as failures.


Secondary Outcome Measures:
  • Device Safety (evaluated by the data collected on device related adverse events, serious device related adverse events, all adverse and serious adverse events) [ Time Frame: 6 months ]
    The safety of the device will be evaluated by the data collected on device related adverse events, serious device related adverse events, all adverse and serious adverse events (regardless of whether there is a causal relationship to the device), and device malfunctions leading to expander removal and/or replacement.


Estimated Enrollment: 60
Study Start Date: October 2015
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AeroForm Tissue Expander
AeroForm Tissue Expansion inflation with carbon dioxide by remote control
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504424


Locations
United States, California
Marin General Hospital
Greenbrae, California, United States, 94904
Good Samaritan Hospital, San Jose
San Jose, California, United States, 95008
United States, Florida
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Faulkner Hospital
Boston, Massachusetts, United States, 02130
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
United States, New York
Columbia University
New York, New York, United States, 10032-3713
United States, North Carolina
Presbyterian Medical Center
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
AirXpanders, Inc.
Investigators
Study Chair: Daniel Jacobs, M.D. AirXpanders Chief Medical Officer
Principal Investigator: Jeffrey Ascherman, M.D. Columbia University
  More Information

Responsible Party: AirXpanders, Inc.
ClinicalTrials.gov Identifier: NCT02504424     History of Changes
Other Study ID Numbers: CTP-0005 AirXpanders
First Submitted: July 20, 2015
First Posted: July 22, 2015
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by AirXpanders, Inc.:
Tissue Expansion
Tissue Expander
Breast Tissue Expansion
Breast Tissue Expander
Breast Reconstruction
2 Stage Breast Reconstruction


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