NCT02504424 (XPAND-II) is a NA clinical trial of AeroForm Tissue Expander in Breast Cancer, sponsored by AirXpanders, Inc..

Who is sponsoring NCT02504424?

NCT02504424 is sponsored by AirXpanders, Inc..

What drugs are being tested in NCT02504424?

Interventions in NCT02504424: AeroForm Tissue Expander.

What condition does NCT02504424 study?

NCT02504424 studies Breast Cancer.

Is NCT02504424 still recruiting?

NCT02504424 is currently completed. Last updated 29 January 2019.

Are results published for NCT02504424?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-29 · How we verify

NCT02504424: XPAND-II

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

Completed NA Results posted Last updated 29 January 2019

What this trial tests

NA trial testing AeroForm Tissue Expander in Breast Cancer in 50 participants. Completed in 26 September 2017.

Timeline

12 November 2015

Primary endpoint
3 May 2017

26 September 2017

Quick facts

Lead sponsor	AirXpanders, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	12 November 2015
Primary completion	3 May 2017
Estimated completion	26 September 2017
Sites	8 locations across United States

Drugs / interventions tested

AeroForm Tissue Expander

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

AirXpanders, Inc.

Who can join

Adults 18 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
AeroForm Tissue Expander	80

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

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.

Group	Value	95% CI
AeroForm Tissue Expander	80

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AeroForm Tissue Expander

Serious: 11/50 (22%)

Deaths: 0/50

Serious adverse events (7 terms)

Reaction	System	AeroForm Tissue Expander
cellulitis	Reproductive system and breast disorders	—
inflammation (red breast syndrome)	Reproductive system and breast disorders	—
wound dehiscence	Reproductive system and breast disorders	—
hematoma	Reproductive system and breast disorders	—
seroma	Reproductive system and breast disorders	—
neutropenic fever, weakness	Immune system disorders	—
urinary tract infection	Renal and urinary disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	AeroForm Tissue Expander
erythema	Skin and subcutaneous tissue disorders	—
seroma	Reproductive system and breast disorders	—

Most-reported serious reactions: cellulitis, inflammation (red breast syndrome), wound dehiscence, hematoma, seroma, neutropenic fever, weakness, urinary tract infection.

Data from ClinicalTrials.gov NCT02504424 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02504424 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AirXpanders, Inc.
Last refreshed: 29 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02504424.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing