Clinical trial · Interventional
Patient Controlled Tissue Expansion for Breast Reconstruction
AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction
NCT01425268CI-TRIAL-00028293XPANDcompletedN/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 compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AeroForm Tissue Expansion | Device | — | UNRESOLVED |
| Saline Tissue Expansion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AeroForm Tissue Expansion
- description
- AeroForm Tissue Expansion inflation with carbon dioxide by remote control
- interventionNames
- Device: AeroForm Tissue Expansion
- type
- ACTIVE_COMPARATOR
- label
- Saline Tissue Expansion
- description
- Saline Tissue Expansion inflated by needle injections of saline
- interventionNames
- Procedure: Saline Tissue Expansion
Primary outcomes (1)
- measure
- Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is a woman between the ages of 18-70. 2. Subject needs to have tissue expansion as part of her breast reconstruction. 3. Subject is able to provide written informed consent. 4. Subject is able and willing to comply with all of the study requirements. 5. Subject is able to understand and manage at home dosing regimen. Exclusion Criteria: 1. Subjects skin is not suitable for tissue expansion. 2. Subject has remaining tumor cells following her mastectomy. 3. Subject has a current or prior infection at the intended expansion site. 4. Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used. 4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted. 5\. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site. 6\. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes). 7\. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin). 8\. Subject is currently participating in a concurrent investigational drug or device study. 9\. Subject is a current tobacco smoker. 10. Subject is overweight (BMI \> 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not \> 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted. 12\. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device. 13\. Subject is pregnant or planning on becoming pregnant during the study period. 14\. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.
References
Publications (2)
- BACKGROUNDAscherman JA, Zeidler K, Morrison KA, Appel JZ, Berkowitz RL, Castle J, Colwell A, Chun Y, Johnson D, Mohebali K. Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial. Plast Reconstr Surg. 2016 Dec;138(6):1161-1170. doi: 10.1097/PRS.0000000000002784. PMID 27879582
- DERIVEDZeidler KR, Berkowitz RL, Chun YS, Alizadeh K, Castle J, Colwell AS, Desai AR, Evans G, Hollenbeck S, Johnson DJ, Morris D, Ascherman JA. AeroForm patient controlled tissue expansion and saline tissue expansion for breast reconstruction: a randomized controlled trial. Ann Plast Surg. 2014 May;72 Suppl 1:S51-5. doi: 10.1097/SAP.0000000000000175. PMID 24740025