Blossom Tissue Expander for Breast Reconstruction

Overseen By Elizabeth Tadevosyan, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Steroids

Disqualifiers: Active breast cancer, Major comorbidities, Connective tissue disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device for breast reconstruction called the Blossom Smart Expander. Unlike the usual method, which requires frequent saline injections to expand breast tissue, this device slowly and continuously adds saline on its own, reducing discomfort. The study compares the effectiveness of this new technology with the standard method of tissue expansion. Women considering breast reconstruction and planning to use a two-stage implant process might be a good fit for this trial. As an unphased trial, participants contribute to innovative research that may enhance future breast reconstruction experiences.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have recently used steroids, you may not be eligible to participate.

What prior data suggests that the Blossom Smart Expander Device is safe for breast reconstruction?

Research has shown that the Blossom Smart Expander Device is generally safe for breast reconstruction. One study found complications in about 4.5% of cases, which is encouraging. This indicates that most people tolerate the device well. The device gradually and continuously stretches the tissue, helping to avoid excessive pressure on the skin. This method may be less uncomfortable than traditional expanders that require frequent injections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Blossom Smart Expander Device for breast reconstruction because it offers an innovative, automatic process for tissue expansion. Unlike the standard method, which requires multiple saline injections over time, the Blossom device automates the expansion, potentially reducing the frequency of doctor visits and patient discomfort. This new approach could streamline the reconstruction process, making it more convenient and less invasive for patients.

What evidence suggests that the Blossom Smart Expander Device is effective for breast reconstruction?

In this trial, participants will join one of two treatment arms. Some participants will receive the Blossom Smart Expander Technology, which can make breast reconstruction more comfortable by gradually adding small amounts of saline, thus reducing the need for needle injections. Research has shown that this method has a lower complication rate of about 4.5%, which is promising compared to the usual method. One study found that the Blossom device helps achieve full expansion faster, suggesting it might be not only more comfortable but also quicker for patients undergoing breast reconstruction. Meanwhile, other participants will receive the standard tissue expansion method, which involves serial injections of sterile saline into the tissue expander during postoperative follow-up visits. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Ability to understand and the willingness to sign a written informed consent document (English language)

Exclusion Criteria

Unable to understand and sign the English language consent forms

I currently have active breast cancer.

I am over 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Postoperative Follow-up

Placement of the tissue expander and initial follow-up within 1 week of surgery

1 week

1 visit (in-person)

Tissue Expansion

Tissue expansion using the Blossom Smart Expander or standard saline injections, with weekly follow-ups until completion

3-6 months

Weekly visits (in-person)

Follow-up and Preparation for Second Stage Surgery

Monthly follow-ups as needed until the second stage surgery for implant exchange

Up to 6 months

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Blossom Smart Expander Device
• Standard Tissue Expansion

Trial Overview 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.

How Is the Trial Designed?

Group I: Blossom tissue expander Experimental Treatment 1 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 expansion Active Control 1 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Marz Medical, Inc.

Collaborator

Trials

1

Recruited

20+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7520237/

Blossom smart expander technology for tissue ... The overall complication rate of this study was 4.5%, which is promising compared to the reported complication rates of two-stage breast reconstruction with TEs ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/69/NCT03657069/Prot_SAP_000.pdf

A Pilot Study of Applying New Device Technologies for Tissue ... ... effectiveness of the application of. Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction. This new study may ...

3. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.5999/aps.2020.00535

Thieme E-Journals - Archives of Plastic Surgery / Abstract Blossom smart expander technology for tissue expander-based breast reconstruction facilitates shorter duration to full expansion: A pilot study.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-01702

Blossom Smart Expander Technology in Breast ... This phase I trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy.

5. researchgate.net researchgate.net/publication/344392963_Blossom_smart_expander_technology_for_tissue_expander-based_breast_reconstruction_facilitates_shorter_duration_to_full_expansion_A_pilot_study

(PDF) Blossom smart expander technology for tissue ... Background: Complications after 2-stage tissue expander/implant breast reconstruction have been studied as outcomes of a single procedure.

6. ctv.veeva.com ctv.veeva.com/study/post-marketing-clinical-monitoring-of-safety-and-performance-of-breast-tissue-expander-for-breast-re

Post-marketing Clinical Monitoring of Safety and Performance of ... The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction.