- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02293798
Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold
August 21, 2019 updated by: Mark Mofid MD
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 Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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La Jolla, California, United States, 92037
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SERI
Subjects receiving SERI for mastopexy
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surgical implant
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Areolar Dilation of up to 6mm at 12 Months
Time Frame: 12 months after SERI implantation
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areolar dilation of up to 6mm
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12 months after SERI implantation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
November 13, 2014
First Submitted That Met QC Criteria
November 13, 2014
First Posted (Estimate)
November 18, 2014
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
August 21, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 820
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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