MastopexyNCT02293798
Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold
A study testing silk surgical scaffold in people with Mastopexy, run by Mark Mofid MD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical performance of SERI® Surgical Scaffold to maintain the size of the areola by providing additional soft tissue support after circumferential periareolar mastopexy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastopexy
- What is being tested?
- silk surgical scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2016
- 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
- Female, age 18 years or older desiring a reduction in size of nipple areola complex
- Be in good health and suited to general anesthesia and planned treatments
- Non smokers
- If the subject is of childbearing potential, have a urine pregnancy test evaluated as negative (assessed at baseline examination (Visit 1), agree to use contraception as prevention to avoid pregnancy during the study period
- Previous augmentation with silicone-filled or saline-filled breast implants or patients desiring periareolar mastopexy
- Requiring surgery for ptotic breasts
Who cannot join
- BMI (Body Mass Index) that is ≥ 30 kg/m2
- Active smoker or have smoked within 6 weeks prior to screening/qualification visit (Visit 1)
- Pregnant or nursing
- Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
- Previous mastectomy or lumpectomy
- Abscess or infection in the body at the time of enrollment
Show all 19Show fewer
- 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
- Is taking medications known to impair wound healing (e.g. corticosteroids, chemotherapeutic agents etc.,)
- Bleeding disorders (e.g., Hemophilia, von Willebrand Disease) including the following medications \& supplements: Warfarin, platelet inhibitors (e.g. NSAIDs or Clopidogrel) not stopped within 2 weeks of the operation and herbal supplements known to predispose to bleeding (e.g. Gingko and Ginseng)
- 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
- Be currently enrolled in another clinical study of an implanted device in the breast or plan to enroll in another clinical study within the study period, which could affect wound healing in the breast repair site and/or would not allow the patient to attend all study visits as outlined within this protocol
- Product contraindications for use of SERI® Surgical Scaffold per the supplied package insert (e.g., hypersensitivity to silk)
- Show psychological characteristics that may have been incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
- Active alcohol/substance abuse problem or have had a relapse within 1 year prior to screening/qualification visit (Visit 1)
- Was not willing to undergo further surgery for revision, if medically required
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the clinical performance of SERI® Surgical Scaffold to maintain the size of the areola by providing additional soft tissue support after circumferential periareolar mastopexy.
- Conditions
- Mastopexy
- Being tested
- silk surgical scaffold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silk surgical scaffoldDevice
Also called SERI surgical scaffold
surgical implant
| Study group | Role | What they receive |
|---|---|---|
| SERI | Experimental | Subjects receiving SERI for mastopexy Receives: Device: silk surgical scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Areolar Dilation of up to 6mm at 12 Months
areolar dilation of up to 6mm
Measured: 12 months after SERI implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2016
- Study completionJun 2016
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 MastopexyStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Mofid MD
- Collaborators
- Allergan
- Responsible party
- Sponsor-investigator, Mark Mofid MD, Mofid, Mehrdad Mark, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293798
- Sponsor's protocol ID
- 820
- Status last verified
- Aug 2019
- First submitted
- 13 Nov 2014
- Last updated
- 10 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold
- ClinicalTrials.gov ID
- NCT02293798
- Acronym / sponsor ID
- 820
- Conditions
- Mastopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mark Mofid MD
- Collaborators
- Allergan
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Posted 10 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical performance of SERI® Surgical Scaffold to maintain the size of the areola by providing additional soft tissue support after circumferential periareolar mastopexy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SERI | Experimental | Device: silk surgical scaffoldSubjects receiving SERI for mastopexy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female, age 18 years or older desiring a reduction in size of nipple areola complex
- Be in good health and suited to general anesthesia and planned treatments
- Non smokers
- If the subject is of childbearing potential, have a urine pregnancy test evaluated as negative (assessed at baseline examination (Visit 1), agree to use contraception as prevention to avoid pregnancy during the study period
- Previous augmentation with silicone-filled or saline-filled breast implants or patients desiring periareolar mastopexy
Key exclusion criteria (19 listed)
- BMI (Body Mass Index) that is ≥ 30 kg/m2
- Active smoker or have smoked within 6 weeks prior to screening/qualification visit (Visit 1)
- Pregnant or nursing
- Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
- Previous mastectomy or lumpectomy
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 |
|---|---|---|
| silk surgical scaffoldAlso: SERI surgical scaffoldsurgical implant | Device | SERI |
Primary outcome
Number of Participants With Areolar Dilation of up to 6mm at 12 Months
Time frame: 12 months after SERI implantation
areolar dilation of up to 6mm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing silk surgical scaffold in people with Mastopexy, run by Mark Mofid MD 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 6 inclusion and 19 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 10 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2019). 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?
Number of Participants With Areolar Dilation of up to 6mm at 12 Months (time frame: 12 months after SERI implantation). 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 10 Sep 2019.