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Trial record 3 of 48 for:    SERI

Seri Surgical Scaffold Support of the Lower Pole of the Breast (SeriSupport)

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ClinicalTrials.gov Identifier: NCT02016612
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Allergan Medical
Information provided by (Responsible Party):
Bradley Bengtson, M.D., Bengtson Center

Brief Summary:
Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D Imaging system reporting the amount of breast tissue above and below the nipple level.

Condition or disease Intervention/treatment Phase
Recurrent Ptosis of the Breast Device: Seri Surgical Scaffold Not Applicable

Detailed Description:
Patients having augmentation mastopexy or breast reduction will be informed about Seri Scaffold and allowed to have Seri support included in their surgery or not. If the choose the scaffold will be placed under the skin in the lower pole of the breast as an internal hammock to help take weight off of the breast and potentially help prevent future stretch of the lower pole.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Seri Surgical Scaffold (TM) Support of the Lower Pole of the Breasts in Augmentation Mastopexy or Breast Reduction Patients
Study Start Date : October 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 30, 2016

Arm Intervention/treatment
Active Comparator: Reduction, Mastopexy No Implant, No Seri
Patients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used
Device: Seri Surgical Scaffold
An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
Other Names:
  • Seri
  • Seri Scaffold

Active Comparator: Mastopexy, Implant no Seri Scaffold
Mastopexy with implant, No Seri Surgical Scaffold support is used
Device: Seri Surgical Scaffold
An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
Other Names:
  • Seri
  • Seri Scaffold

Active Comparator: Breast Reduction with Seri Support
Patients undergoing breast reduction with the use of Seri Surgical scaffold support
Device: Seri Surgical Scaffold
An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
Other Names:
  • Seri
  • Seri Scaffold

Active Comparator: Augmentation Mastopexy, Implant and Seri
Augmentation Mastopexy patients where Seri Surgical scaffold is used
Device: Seri Surgical Scaffold
An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
Other Names:
  • Seri
  • Seri Scaffold




Primary Outcome Measures :
  1. Nipple to Fold Measurement on Stretch [ Time Frame: 1 year post op ]
    The Nipple to fold will be measured manually over time to 1 year


Secondary Outcome Measures :
  1. Percent Breast Tissue Above Nipple [ Time Frame: 1 year post op ]
    The percentage of breast tissue above and below the horizontal plane of the nipple over time



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Age =>18 years

  • requesting procedure
  • No active cancer or infection

Exclusion Criteria:

  • Known allergy to silk
  • Pregnant or lactating

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): NCT02016612


Locations
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United States, Michigan
Bengtson Center for Aesthetics and Plastic Surgery
Grand Rapids, Michigan, United States, 49503
Center for Aesthetics and Plastic Surgery
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Bengtson Center
Allergan Medical
Investigators
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Principal Investigator: Bradley P Bengtson, MD Bengtson Center
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Responsible Party: Bradley Bengtson, M.D., Bradley P Bengtson, MD FACS, Bengtson Center
ClinicalTrials.gov Identifier: NCT02016612    
Other Study ID Numbers: 007
First Posted: December 20, 2013    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bradley Bengtson, M.D., Bengtson Center:
Recurrent
Ptosis
Reduction
Mammoplasty
Mastopexy
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical