Breast CancerXPAND-IINCT02504424

AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

A study testing AeroForm Tissue Expander in people with Breast Cancer, run by AirXpanders, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: AeroForm Tissue Expander
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 8 sitesUnited States
Study dates: 12 Nov 2015to 26 Sep 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Faulkner Hospital
Boston, Massachusetts, 02130
Presbyterian Medical Center
Charlotte, North Carolina, 28207
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Marin General Hospital
Greenbrae, California, 94904
Columbia University
New York, New York, 10032-3713
Good Samaritan Hospital, San Jose
San Jose, California, 95008
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605

Other trials in United States

About this study

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

Read the 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).

Conditions: Breast Cancer
Being tested: AeroForm Tissue Expander
Keywords: Tissue Expansion, Tissue Expander, Breast Tissue Expansion, Breast Tissue Expander, Breast Reconstruction, 2 Stage Breast Reconstruction
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AeroForm Tissue ExpanderDevice
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.

Study groups in NCT02504424
Study group	Role	What they receive
AeroForm Tissue Expander	Experimental	AeroForm Tissue Expansion inflation with carbon dioxide by remote control Receives: Device: AeroForm Tissue Expander

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event
The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.
Measured: 6 months

Secondary outcomes (1)

Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.
Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in the analyses due to not completing the second stage surgery and withdrawal of consent.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 201526 Sep 2017

First posted22 Jul 2015 (estimated)
Study start12 Nov 2015
Primary completion3 May 2017
Study completion26 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02504424
Sponsor's protocol ID: CTP-0005 AirXpanders
Acronym: XPAND-II
Status last verified: Jan 2019
First submitted: 20 Jul 2015
Last updated: 29 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ascherman JA, Zeidler K, Morrison KA, Appel J, Castle J, Chun Y, Colwell A, Mohebali K, Stokes T, Sudarsky L. Results of XPAND II: A Multicenter, Prospective, Continued-Access Clinical Trial Using the AeroForm Tissue Expander for Two-Stage Breast Reconstruction. Plast Reconstr Surg. 2020 Jan;145(1):21e-29e. doi: 10.1097/PRS.0000000000006395.
PubMed 31881599

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)
ClinicalTrials.gov ID: NCT02504424
Acronym / sponsor ID: XPAND-II / CTP-0005 AirXpanders
Conditions: Breast Cancer
Keywords: Tissue Expansion, Tissue Expander, Breast Tissue Expansion, Breast Tissue Expander, Breast Reconstruction, 2 Stage Breast Reconstruction
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: AirXpanders, Inc.Industry (pharma, biotech, devices)
Study start: 12 Nov 2015 (actual)
Primary completion: 3 May 2017 (actual)
Study completion: 26 Sep 2017 (actual)
First posted: 22 Jul 2015 (estimated)
Results: Posted 5 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AeroForm Tissue Expander	Experimental	Device: AeroForm Tissue ExpanderAeroForm Tissue Expansion inflation with carbon dioxide by remote control

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AeroForm Tissue ExpanderThe 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.	Device	AeroForm Tissue Expander

Primary outcome

Number of Breasts With 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 is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.

1 secondary outcome

Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.
Time frame: 6 months

Results and safety

Results posted to the registry on 5 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AeroForm Tissue Expander	50	48

Primary outcome: Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event

Time frame: 6 months. Count of units. Unit: breasts

Measure	AeroForm Tissue Expander n = 48
Value	80

AeroForm Tissue Expander: percent of breasts successfully exchange: 100
AeroForm Tissue Expander: % breasts successfully exchanged: 100

Population analysed: * of participants is 48: # treated (50) minus participant failed exchange of both breasts for non-device related reason (1) and participant not analyzed due to withdrawal (1). * of breasts is 80: # breasts treated (86) minus # breasts failed exchanged due to non-device related reason (4) and # breasts not analyzable due to withdrawal (2).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AeroForm Tissue Expander	11 of 50 (22%)	8 of 50 (16%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31881599Ascherman JA, Zeidler K, Morrison KA, Appel J, Castle J, Chun Y, Colwell A, Mohebali K, Stokes T, Sudarsky L. Results of XPAND II: A Multicenter, Prospective, Continued-Access Clinical Trial Using the AeroForm Tissue Expander for Two-Stage Breast Reconstruction. Plast Reconstr Surg. 2020 Jan;145(1):21e-29e. doi: 10.1097/PRS.0000000000006395.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Jacobs, M.D. study chair

AirXpanders Chief Medical Officer

Jeffrey Ascherman, M.D. principal investigator

Columbia University

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AeroForm Tissue Expander in people with Breast Cancer, run by AirXpanders, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02504424, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.