Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Blossom tissue expander
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.
Standard tissue expansion
DeviceMentor 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Blossom tissue expanderExperimental treatment 1 intervention
Group B: Standard tissue expansionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.2
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.
Time frame
Monitoring for complications will occur until removal of the tissue expander device during the second stage surgery (approximately 6 months)Secondary outcomes
1
Patient satisfaction (BreastQ)
Patient satisfaction will be assessed using the validated BreastQ 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).2
Patient satisfaction (device specific survey)
Patient satisfaction will be assessed using a 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).3
Pain associated with tissue expansion
Pain will be assessed using a study-specific survey.
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
Marz Medical, Inc.
Collaborator
Source ClinicalTrials.gov