Clinical trial · Interventional
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)
- 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 phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. It may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blossom | Device | — | UNRESOLVED |
| Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (Blossom Smart Expander Technology)
- description
- After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.
- interventionNames
- Device: Blossom
- Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
Primary outcomes (1)
- measure
- Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved
- timeFrame
- Assessed weekly for up to 12 weeks
- description
- Measured by calculating the number of days from expander placement to achievement of desired expansion volume. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of breast cancer or reason for prophylactic mastectomy (e.g., BRCA mutation and/or strong family history of breast cancer), both unilateral or bilateral mastectomy * No prior breast surgery (excluding biopsy and lumpectomy) or breast radiation * Ability to understand and the willingness to sign a written informed consent document * No life expectancy restrictions * Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed * No requirements for organ and marrow function Exclusion Criteria: * Recent steroid use * No major medical comorbidities (defined as American Society of Anesthesiologists \[ASA\] III or greater) * No connective tissue disorder * Prior breast surgery, excluding biopsy and lumpectomy * History of or plan for breast radiation * Pregnancy and nursing patients will be excluded from the study * No restrictions regarding use of other investigational agents * No exclusion criteria related to history of allergic reactions * No exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent * No other agent-specific exclusion criteria * No exclusion of cancer survivors or those who are human immunodeficiency virus (HIV)-positive
References
Publications (0)
Data not yet available