Seri Surgical Scaffold Support of the Lower Pole of the Breast

NCT02016612 | Completed Results

• 1 other identifier: 007
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Recurrent Ptosis of the Breast

Keywords

Recurrent; Ptosis; Reduction; Mammoplasty; Mastopexy

Outcome Measures

Primary Outcomes (1)

• Nipple to Fold Measurement on Stretch

  The Nipple to fold will be measured manually over time to 1 year

  1 year post op

Secondary Outcomes (1)

• Percent Breast Tissue Above Nipple

  1 year post op

Study Arms (4)

Reduction, Mastopexy No Implant, No Seri

ACTIVE COMPARATOR

Patients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used

Device: Seri Surgical Scaffold

Mastopexy, Implant no Seri Scaffold

ACTIVE COMPARATOR

Mastopexy with implant, No Seri Surgical Scaffold support is used

Device: Seri Surgical Scaffold

Breast Reduction with Seri Support

ACTIVE COMPARATOR

Patients undergoing breast reduction with the use of Seri Surgical scaffold support

Device: Seri Surgical Scaffold

Augmentation Mastopexy, Implant and Seri

ACTIVE COMPARATOR

Augmentation Mastopexy patients where Seri Surgical scaffold is used

Device: Seri Surgical Scaffold

Interventions

Seri Surgical Scaffold DEVICE

An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.

Also known as: Seri, Seri Scaffold

Augmentation Mastopexy, Implant and Seri; Breast Reduction with Seri Support; Mastopexy, Implant no Seri Scaffold; Reduction, Mastopexy No Implant, No Seri

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age =\>18 years
• requesting procedure
• No active cancer or infection

You may not qualify if:

• Known allergy to silk
• Pregnant or lactating

Sponsors & Collaborators

• Bengtson Center: lead
• Allergan Medical: collaborator

Study Sites (2)

Bengtson Center for Aesthetics and Plastic Surgery

Grand Rapids, Michigan, 49503, United States

Location

Center for Aesthetics and Plastic Surgery

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Recurrence; Blepharoptosis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Dr Bradley Bengtson
• Organization: Bengtson Center

drb@bengtsoncenter.com

616 588 8880

Study Officials

• Bradley P Bengtson, MD

  Bengtson Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bradley P Bengtson, MD FACS

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 30, 2016
• Last Updated: February 13, 2018
• Results First Posted: February 13, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)