Subjects Requiring Revision Breast Augmentation SurgeryNCT02030938
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
A study testing SERI® Surgical Scaffold in people with Subjects Requiring Revision Breast Augmentation Surgery, run by Sofregen Medical, Inc. at 5 sites in United States.
Trial summary
An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Subjects Requiring Revision Breast Augmentation Surgery
- What is being tested?
- SERI® Surgical Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Negative nicotine test at screening visit
- Previous augmentation with silicone-filled or saline-filled breast implants requiring Revision Augmentation surgery for increased nipple:inframammary fold distance
- Well vascularized skin flaps that can be approximated without tension
Who cannot join
- BMI (Body Mass Index) that is ≥ 30 kg/m2
- Active smoker or have smoked within 6 weeks prior to screening visit
- Pregnant or nursing
- Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
- Carcinoma of the breast
- Previous mastectomy or lumpectomy
Show all 14Show fewer
- Abscess or infection in the body at the time of enrollment
- Had any disease, including uncontrolled diabetes (e.g., HbAIc > 8%), that is clinically known to impact wound healing ability. For example: collagen-vascular, connective tissue or autoimmune disorders (e.g., Systemic Lupus, Rheumatoid Arthritis, Scleroderma)
- Subjects with diagnosed diabetes must have HbAIc ≤ 8% within 3 months of enrollment
- Showed tissue characteristics that were clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration
- Had, or was under treatment for, any condition that may have constituted an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
- History of prior implantation of any surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) in the breast
- Implantation of any non-SERI® surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) during the study period
- Product contraindications for use of SERI® Surgical Scaffold per the supplied package insert (e.g., hypersensitivity to silk)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mofid Plastic Surgery
La Jolla, California, 92037
Plastic Surgery Clinic
Mountlake Terrace, Washington, 98043
Kind Chang Plastic Surgery - California Pacific Medical Center
San Francisco, California, 94114
Washington University School of Medicine
St Louis, Missouri, 63110
Somerset Plastic Surgery
Troy, Michigan, 48084
About this study
An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.
Read the detailed description
This is a single arm prospective study. Approximately 4 investigational sites will enroll and follow subjects who meet the study criteria.The study will span a total of approximately 18 months: an estimated 6 months for recruitment and 12 months for follow up. 50 subjects will be enrolled in the study. It is anticipated that given an average of 1.5 operated breasts per subject enrolled for Revision Augmentation surgery that 75 implantations of SERI® surgical scaffold will occur.
- Being tested
- SERI® Surgical Scaffold
- Keywords
- breast implant, revision augmentation, stretch deformity, fold malposition, bottoming out
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SERI® Surgical ScaffoldDevice
Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
| Study group | Role | What they receive |
|---|---|---|
| SERI® scaffold implanted breasts | Experimental | SERI® Surgical Scaffold is a knitted, multifilament, bioengineered, silk mesh. It is mechanically strong, biocompatible, BIOSILK® purified, and long term bioresorbable. SERI® Surgical Scaffold is a sterile, single use only mesh and is supplied as a 10 x 25 cm sheet. SERI® Surgical Scaffold provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold like) construction of its mesh. When long term bioresorption occurs and the patient's own tissue replaces the implanted scaffold over time the mechanical integrity of the repair is maintained.
SERI® Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. Receives: Device: SERI® Surgical Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months.
This refers to the proportion of implanted breasts that will require reoperation for the recurrence of the initial cause of the increase in nipple to inframammary fold distance at the end of the 12-month follow-up period. Reoperation rate outcomes are presented as number of implanted breasts that required a reoperation out of the overall number of units analyzed.
Measured: 12 months
Secondary outcomes (5)
Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months
This refers to the proportion of implanted breasts that will require reoperation for any cause at the end of the 12 month follow up period. The outcome is presented as the number of implanted breasts that required reoperation from the overall number of units analyzed.
Measured: 12 months
AE Incidence Rates (Per Implanted Breast) at 30 Days
This refers to the AE incidence rate per implanted breast at thirty days. Outcome is reported as the number of adverse events reported for the overall number of units analyzed.
Measured: 30 days
AE Incidence Rates (Per Implanted Breast) at 12 Months
This refers to the AE incidence rate per implanted breast at twelve months. Outcome is reported as the number of adverse events reported for the overall number of units analyzed.
Measured: 12 months
Change in Mammometry From Baseline to 12 Months (Per Implanted Breast)
Mammometry is defined as standardized breast measurements. Mammometry was performed by direct measurement (ie with measuring tape) and indirectly through VECTRA imaging.
Measured: 12 months
Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient)
The BREAST-Q is a self-administered questionnaire developed at the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. This instrument specifically measured subject satisfaction and health related quality of life (QoL) following different types of breast surgery (reconstruction,augmentation, reduction, and mastectomy only). A subset of 4 scales from the augmentation module (Satisfaction with breasts, Satisfaction with outcome, Psychosocial wellbeing and Sexual wellbeing) were used in this study.
In accordance with the BREAST-Q manual, subject scores were transformed into linearized measurements on a 0 to 100 scale, using the QScore software which was developed based on the Rasch model. For the transformed scores, a higher score indicated greater satisfaction or higher function.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subjects Requiring Revision Breast Augmentation SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofregen Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel Kind, Principal investigator, Kind Chang Plastic Surgery - California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030938
- Sponsor's protocol ID
- GMA-SERI-13-001
- Status last verified
- Nov 2021
- First submitted
- 7 Jan 2014
- Last updated
- 28 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
- ClinicalTrials.gov ID
- NCT02030938
- Acronym / sponsor ID
- GMA-SERI-13-001
- Keywords
- breast implant, revision augmentation, stretch deformity, fold malposition, bottoming out
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sofregen Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Posted 28 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.
Detailed description
This is a single arm prospective study. Approximately 4 investigational sites will enroll and follow subjects who meet the study criteria.The study will span a total of approximately 18 months: an estimated 6 months for recruitment and 12 months for follow up. 50 subjects will be enrolled in the study. It is anticipated that given an average of 1.5 operated breasts per subject enrolled for Revision Augmentation surgery that 75 implantations of SERI® surgical scaffold will occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SERI® scaffold implanted breasts | Experimental | Device: SERI® Surgical ScaffoldSERI® Surgical Scaffold is a knitted, multifilament, bioengineered, silk mesh. It is mechanically strong, biocompatible, BIOSILK® purified, and long term bioresorbable. SERI® Surgical Scaffold is a sterile, single use only mesh and is supplied as a 10 x 25 cm sheet. SERI® Surgical Scaffold provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold like) construction of its mesh. When long term bioresorption occurs and the patient's own tissue replaces the implanted scaffold over time the mechanical integrity of the repair is maintained. SERI® Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Negative nicotine test at screening visit
- Previous augmentation with silicone-filled or saline-filled breast implants requiring Revision Augmentation surgery for increased nipple:inframammary fold distance
- Well vascularized skin flaps that can be approximated without tension
Key exclusion criteria (14 listed)
- BMI (Body Mass Index) that is ≥ 30 kg/m2
- Active smoker or have smoked within 6 weeks prior to screening visit
- Pregnant or nursing
- Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
- Carcinoma of the breast
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 |
|---|---|---|
| SERI® Surgical ScaffoldStandard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly. | Device | SERI® scaffold implanted breasts |
Primary outcome
Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months.
Time frame: 12 months
This refers to the proportion of implanted breasts that will require reoperation for the recurrence of the initial cause of the increase in nipple to inframammary fold distance at the end of the 12-month follow-up period. Reoperation rate outcomes are presented as number of implanted breasts that required a reoperation out of the overall number of units analyzed.
5 secondary outcomes
Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months
Time frame: 12 months
AE Incidence Rates (Per Implanted Breast) at 30 Days
Time frame: 30 days
AE Incidence Rates (Per Implanted Breast) at 12 Months
Time frame: 12 months
Change in Mammometry From Baseline to 12 Months (Per Implanted Breast)
Time frame: 12 months
Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.
Gabriel Kind principal investigator
Kind Chang Plastic Surgery - California Pacific Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SERI® Surgical Scaffold in people with Subjects Requiring Revision Breast Augmentation Surgery, run by Sofregen Medical, Inc. at 5 sites 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 28 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. (time frame: 12 months). 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 28 Dec 2021.