Tissue ExpansionNCT05975372
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
A study testing Blossom tissue expander and Standard tissue expansion in people with Tissue Expansion and Implant Based Breast Reconstruction, run by Stanford University at 1 site in United States.
Trial summary
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be uncomfortable for… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue Expansion, Implant Based Breast Reconstruction
- What is being tested?
- Blossom tissue expander and Standard tissue expansion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2023to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander/ implant-based breast reconstruction will be approached for potential enrollment in the study.
Who cannot join
- Patients with active breast cancer; recent steroid use; major medical comorbidities (defined as ASA III or greater); a connective tissue disorder; are pregnant or nursing; are unable to understand and sign the english language consent forms; or age over 65 years, will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Hospital and Clinics
Palo Alto, California, 94304
Dung H Nguyen, MD, PharmD, (650) 725-2766, nguyendh@stanford.edu
Elizabeth Tadevosyan, BS, 818-269-1950, etadyan@stanford.edu
About this study
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently available on the market, aims to achieve the same tissue expansion while avoiding frequent injections through the skin by means of an expansion device that slowly and continuously injects a very small amount of saline. Expansion of the device is based on pressure and volume in the expander, allowing for a tailored expansion process for individual patients' physiology. The purpose of this study is to assess the clinical effectiveness of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction/ augmentation compared to standard tissue expansion methods.
Read the detailed description
All consenting patients presenting to Dr. Dung Nguyen's breast reconstruction clinic and opting for 2-staged tissue expander/implant-based breast reconstruction or augmentation will be given the option of study enrollment. Consenting patients will be enrolled and randomized 1:1 to undergo standard 2-staged breast reconstruction/ augmentation with conventional tissue expansion (control) or with application Blossom Smart Expander Technology (intervention) in the first stage reconstruction (tissue expansion).
The intervention group involves the placement of the Mentor Spectrum tissue expander coupled with Blossom Syringe Assist device. The postoperative follow-up and subsequent surgery to exchange the device to a permanent implant is normal part of standard care.
A Mentor Spectrum adjustable saline breast implant for expansion, coupled with the Blossom Syringe Assist device, will be 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. 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.
- Being tested
- Blossom tissue expander, Standard tissue expansion
- Keywords
- Implant based breast reconstruction, Tissue expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blossom tissue expanderDevice
Also called Blossom smart expander device, Marz blossom syringe assist device, Blossom syringe assist device
Mentor spectrum adjustable saline breast implant for expansion is placed with the Blossom tissue expander above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.
Standard tissue expansionDevice
Mentor spectrum adjustable saline breast implant for expansion is placed with (without the Blossom tissue expander) above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Blossom tissue expander | Experimental | 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. Receives: Device: Blossom tissue expander |
| Standard tissue expansion | Active comparator | 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. Receives: Device: Standard tissue expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until completion of tissue expansion
The time between placement of the tissue expander (stage 1 surgery) and completion of tissue expansion will be recorded and compared between each study arm.
Measured: Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.
Incidence of complications
Any occurrence of surgical complications, such as infection, seroma, hematoma, extrusion, wound breakdown, and/ or device malfunction, etc. will be monitored and recorded in each study arm.
Measured: Monitoring for complications will occur until removal of the tissue expander device during the second stage surgery (approximately 6 months)
Secondary outcomes (3)
Patient satisfaction (BreastQ)
Patient satisfaction will be assessed using the validated BreastQ survey.
Measured: 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).
Patient satisfaction (device specific survey)
Patient satisfaction will be assessed using a device-specific survey.
Measured: 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).
Pain associated with tissue expansion
Pain will be assessed using a study-specific survey.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start17 Nov 2023
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue ExpansionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either undergo tissue expansion with the Blossom device (intervention group) or standard tissue expansion methods (control group).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Marz Medical, Inc.
- Responsible party
- Principal investigator, Dung Nguyen, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975372
- Sponsor's protocol ID
- 67363
- Status last verified
- Jun 2026
- First submitted
- 27 Jul 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05975372
- Acronym / sponsor ID
- 67363
- Keywords
- Implant based breast reconstruction, Tissue expansion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Marz Medical, Inc.
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently available on the market, aims to achieve the same tissue expansion while avoiding frequent injections through the skin by means of an expansion device that slowly and continuously injects a very small amount of saline. Expansion of the device is based on pressure and volume in the expander, allowing for a tailored expansion process for individual patients' physiology. The purpose of this study is to assess the clinical effectiveness of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction/ augmentation compared to standard tissue expansion methods.
Detailed description
All consenting patients presenting to Dr. Dung Nguyen's breast reconstruction clinic and opting for 2-staged tissue expander/implant-based breast reconstruction or augmentation will be given the option of study enrollment. Consenting patients will be enrolled and randomized 1:1 to undergo standard 2-staged breast reconstruction/ augmentation with conventional tissue expansion (control) or with application Blossom Smart Expander Technology (intervention) in the first stage reconstruction (tissue expansion).
The intervention group involves the placement of the Mentor Spectrum tissue expander coupled with Blossom Syringe Assist device. The postoperative follow-up and subsequent surgery to exchange the device to a permanent implant is normal part of standard care.
A Mentor Spectrum adjustable saline breast implant for expansion, coupled with the Blossom Syringe Assist device, will be 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. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either undergo tissue expansion with the Blossom device (intervention group) or standard tissue expansion methods (control group).
| Arm | Type | Receives |
|---|---|---|
| Blossom tissue expander | Experimental | Device: Blossom tissue expanderThe 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. |
| Standard tissue expansion | Active comparator | Device: Standard tissue expansionThe 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander/ implant-based breast reconstruction will be approached for potential enrollment in the study.
Key exclusion criteria (1 listed)
- Patients with active breast cancer; recent steroid use; major medical comorbidities (defined as ASA III or greater); a connective tissue disorder; are pregnant or nursing; are unable to understand and sign the english language consent forms; or age over 65 years, will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blossom tissue expanderAlso: Blossom smart expander device, Marz blossom syringe assist device, Blossom syringe assist deviceMentor spectrum adjustable saline breast implant for expansion is placed with the Blossom tissue expander above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation. | Device | Blossom tissue expander |
| Standard tissue expansionMentor spectrum adjustable saline breast implant for expansion is placed with (without the Blossom tissue expander) above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation. | Device | Standard tissue expansion |
Primary outcome
Time until completion of tissue expansion
Time frame: Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.
The time between placement of the tissue expander (stage 1 surgery) and completion of tissue expansion will be recorded and compared between each study arm.
Incidence of complications
Time frame: Monitoring for complications will occur until removal of the tissue expander device during the second stage surgery (approximately 6 months)
Any occurrence of surgical complications, such as infection, seroma, hematoma, extrusion, wound breakdown, and/ or device malfunction, etc. will be monitored and recorded in each study arm.
3 secondary outcomes
Patient satisfaction (BreastQ)
Time frame: 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).
Patient satisfaction (device specific survey)
Time frame: 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).
Pain associated with tissue expansion
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blossom tissue expander and Standard tissue expansion in people with Tissue Expansion and Implant Based Breast Reconstruction, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dung H Nguyen, MD, PharmD ((650) 725-2766, nguyendh@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until completion of tissue expansion (time frame: Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.