Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Und… (NCT03657069) | Clinical Trial Compass
CompletedNot Applicable
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
United States11 participantsStarted 2018-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved