- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05975372
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dung H Nguyen, MD, PharmD
- Phone Number: (650) 725-2766
- Email: nguyendh@stanford.edu
Study Contact Backup
- Name: Shannon Meyer, CCRC
- Phone Number: 510-418-3831
- Email: smeyer27@stanford.edu
Study Locations
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California
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Palo Alto, California, United States, 94304
- Stanford Hospital and Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Blossom tissue expander
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. |
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.
Other Names:
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Active Comparator: Standard tissue expansion
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time until completion of tissue expansion
Time Frame: Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.
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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.
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Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.
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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)
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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.
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Monitoring for complications will occur until removal of the tissue expander device during the second stage surgery (approximately 6 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Patient satisfaction will be assessed using the validated BreastQ survey.
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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).
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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).
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Patient satisfaction will be assessed using a device-specific survey.
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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).
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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).
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Pain will be assessed using a study-specific survey.
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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).
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 67363
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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