Tissue Expansion Clinical Trial
Official title:
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Hospital and Clinics | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Marz Medical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery. | |
Primary | 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. | Monitoring for complications will occur until removal of the tissue expander device during the second stage surgery (approximately 6 months) | |
Secondary | Patient satisfaction (BreastQ) | Patient satisfaction will be assessed using the validated BreastQ survey. | 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). | |
Secondary | Patient satisfaction (device specific survey) | Patient satisfaction will be assessed using a device-specific survey. | 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). | |
Secondary | Pain associated with tissue expansion | Pain will be assessed using a study-specific survey. | 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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