Seri Surgical Scaffold Support of the Lower Pole of the Breast

Recurrent Ptosis of the Breast Clinical Trial

— SeriSupport  

Official title:

Seri Surgical Scaffold (TM) Support of the Lower Pole of the Breasts in Augmentation Mastopexy or Breast Reduction Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016612
• Other study ID #: 007
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: January 17, 2018
• Start date: October 2013
• Est. completion date: November 30, 2016

Study information

• Verified date: January 2018
• Source: Bengtson Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 30, 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Age =>18 years

• requesting procedure

• No active cancer or infection

Exclusion Criteria:

• Known allergy to silk

• Pregnant or lactating

Related Conditions & MeSH terms

• Recurrent Ptosis of the Breast

Intervention

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.

Locations

Country	Name	City	State
United States	Bengtson Center for Aesthetics and Plastic Surgery	Grand Rapids	Michigan
United States	Center for Aesthetics and Plastic Surgery	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Bengtson Center	Allergan Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nipple to Fold Measurement on Stretch	The Nipple to fold will be measured manually over time to 1 year	1 year post op
Secondary	Percent Breast Tissue Above Nipple	The percentage of breast tissue above and below the horizontal plane of the nipple over time	1 year post op