Clinical trial · Interventional
Study of AeroForm Tissue Expander for Breast Reconstruction
AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction
NCT01903174CI-TRIAL-00014111ASPIREcompletedN/AClinicalTrials.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 intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
Conditions
Conditions (2)
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 |
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AeroForm Breast Tissue Expander | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AeroForm Tissue Expansion
- description
- AeroForm Breast Tissue Expander placed after mastectomy
- interventionNames
- Device: AeroForm Breast Tissue Expander
Primary outcomes (1)
- measure
- Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- Adverse Events related to the Breast Reconstruction Procedure
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
1. Subject is female between the ages of 18 - 70.
2. Subject has elected two stage breast reconstruction with tissue expanders.
3. Subject's tissue is amenable to tissue expansion.
4. Subject is able to provide written informed consent.
5. Subject is able and willing to comply with all of the study requirements.
6. Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen.
Exclusion Criteria:
1. Subject has residual gross malignancy following mastectomy.
2. Subject has a current infection at the intended expansion site.
3. Subject has clinically significant radiation fibrosis at the expansion site.
4. Subject has planned radiation at the intended expansion site during the time the expander is implanted.
5. 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).
6. Subject is currently participating in a concurrent investigational drug or device study.
7. Subject is a current tobacco smoker.
8. Subject is overweight with a BMI \> 33.
9. Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
10. Subject is pregnant or planning to become pregnant during the study period.
11. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.
\-References
Publications (0)
Data not yet available
No reference posted for this study.