N/A
N=137
Seri Surgical Scaffold Support of the Lower Pole of the Breast
Recurrent Ptosis of the Breast
Bottom Line
View on ClinicalTrials.gov: NCT02016612 ↗Enrolled (actual)
137
Serious AEs
3.7%
Results posted
Feb 2018
Primary outcome: Primary: Nipple to Fold Measurement on Stretch — 2.3; 2.5; 1.4; 1.4 centimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Seri Surgical Scaffold (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bengtson Center
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nipple to Fold Measurement on Stretch |
2.3; 2.5; 1.4; 1.4 | — |
| SECONDARY Percent Breast Tissue Above Nipple |
35; 30; 15; 18 | — |
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.
Eligibility Criteria
Inclusion Criteria
Age =>18 years
- requesting procedure
- No active cancer or infection
Exclusion Criteria
- Known allergy to silk
- Pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT02016612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.