Clinical trial · Interventional
Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction
Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction
NCT02725801CI-TRIAL-00046983completedN/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)
Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed.
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 |
|---|---|---|---|
| Allergen one-port tissue expander placement | Device | — | UNRESOLVED |
| AlloX2 two-port tissue expander placement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- one-port
- description
- intervention is placement of one-port tissue expander at time of reconstruction
- interventionNames
- Device: Allergen one-port tissue expander placement
- type
- ACTIVE_COMPARATOR
- label
- two-port
- description
- intervention is placement of two-port tissue expander at time of reconstruction
- interventionNames
- Device: AlloX2 two-port tissue expander placement
Primary outcomes (1)
- measure
- Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patient agrees to immediate tissue expander breast reconstruction * a suitable patient for tissue expander reconstruction Exclusion Criteria: * not a surgical candidate for immediate breast reconstruction * age less than 18 * patient declines tissue expander reconstruction * patient anticipated to need radiation therapy postoperatively
References
Publications (0)
Data not yet available
No reference posted for this study.