Clinical trial · Interventional
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)
NCT02504424CI-TRIAL-00036792XPAND-IIcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AeroForm Tissue Expander | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AeroForm Tissue Expander
- description
- AeroForm Tissue Expansion inflation with carbon dioxide by remote control
- interventionNames
- Device: AeroForm Tissue Expander
Primary outcomes (1)
- 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
- timeFrame
- 6 months
- description
- 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.
Secondary outcomes (1)
- measure
- Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDAscherman 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. PMID 31881599