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Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold

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ClinicalTrials.gov Identifier: NCT02293798
Recruitment Status : Completed
First Posted : November 18, 2014
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Mark Mofid MD, Mofid, Mehrdad Mark, M.D.

Brief 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.

Condition or disease Intervention/treatment Phase
Mastopexy Device: silk surgical scaffold Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold
Study Start Date : August 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: SERI
Subjects receiving SERI for mastopexy
Device: silk surgical scaffold
surgical implant
Other Name: SERI surgical scaffold




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293798


Locations
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United States, California
La Jolla, California, United States, 92037
Sponsors and Collaborators
Mark Mofid MD
Allergan
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Responsible Party: Mark Mofid MD, Principal Investigator, Mofid, Mehrdad Mark, M.D.
ClinicalTrials.gov Identifier: NCT02293798    
Other Study ID Numbers: 820
First Posted: November 18, 2014    Key Record Dates
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019
Last Verified: August 2019