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Procedure
Blossom Tissue Expander for Breast Reconstruction
N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient pain will be assessed routinely (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until tissue expansion is complete (3 to 6 months).
Awards & highlights
Study Summary
This trial will compare a breast tissue expander that avoids frequent needle injections with conventional methods of breast reconstruction/augmentation.
Who is the study for?
This trial is for women over 18 who want a two-stage breast reconstruction or augmentation without active cancer, severe health issues, pregnancy, nursing status, age above 65, recent steroid use or connective tissue disorders. They must understand and sign the consent form in English.Check my eligibility
What is being tested?
The study compares Blossom Smart Expander Technology with standard methods of expanding breast skin for reconstruction. The Blossom device aims to reduce discomfort by avoiding frequent saline injections through the skin.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects may include discomfort at the expansion site, infection risk from the device implantation process and possible allergic reactions to materials used in either expander.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of complications
Time until completion of tissue expansion
Secondary outcome measures
Pain associated with tissue expansion
Patient satisfaction (BreastQ)
Patient satisfaction (device specific survey)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Blossom tissue expanderExperimental Treatment1 Intervention
The intervention group involves the placement of the Mentor Spectrum tissue expander coupled with Blossom Syringe Assist device inserted above the pectoralis major muscle in the usual fashion. The nature of the surgery remains identical to that employed for conventional breast tissue expander insertion for reconstruction or augmentation.
Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be automatic via the Blossom device until appropriate volume is achieved. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange.
Group II: Standard tissue expansionActive Control1 Intervention
The standard tissue expansion group will undergo the same procedure with placement of the Mentor Spectrum tissue expander inserted above the pectoralis major muscle in the usual fashion. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be achieved via serial injections of sterile saline into the tissue expander during postoperative follow up visits. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange. The postoperative follow-up and subsequent surgery to exchange the device to a permanent implant is normal part of standard care.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,334,030 Total Patients Enrolled
Marz Medical, Inc.UNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 65 years old.I currently have active breast cancer.I do not have severe health problems apart from my current condition.I have recently used steroids.I am a woman over 18 looking to have breast reconstruction or augmentation for reasons other than cancer.I am considering a two-stage breast reconstruction with an expander and implant.I have a connective tissue disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Blossom tissue expander
- Group 2: Standard tissue expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who qualifies for enrollment in the experiment?
"Prospective applicants must demonstrate evidence of tissue expansion and they need to be between 18-65 years old. A total of 20 people will be accepted into this trial."
Answered by AI
Are elderly participants welcome to join this experiment?
"This investigational trial is open to volunteers aged 18 and above, but under the age of 65."
Answered by AI
Are there any vacancies available to participate in this experiment?
"As per clinicaltrials.gov, this particular medical trial is presently not taking on any new patients. It was first posted to the site on September 1st 2023 and last edited on July 27th 2023; however, there are several other studies that remain open for participant recruitment at present."
Answered by AI
Who else is applying?
What site did they apply to?
Stanford Hospital and Clinics
What portion of applicants met pre-screening criteria?
Met criteria
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