Seri Surgical Scaffold Support of the Lower Pole of the Breast

NCT ID: NCT02016612

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-11-30

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.

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.

Conditions

Recurrent Ptosis of the Breast

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Reduction, Mastopexy No Implant, No Seri

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

Group Type: ACTIVE_COMPARATOR

Seri Surgical Scaffold

Intervention Type: DEVICE

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

Mastopexy, Implant no Seri Scaffold

Mastopexy with implant, No Seri Surgical Scaffold support is used

Group Type: ACTIVE_COMPARATOR

Seri Surgical Scaffold

Intervention Type: DEVICE

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

Breast Reduction with Seri Support

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

Group Type: ACTIVE_COMPARATOR

Seri Surgical Scaffold

Intervention Type: DEVICE

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

Augmentation Mastopexy, Implant and Seri

Augmentation Mastopexy patients where Seri Surgical scaffold is used

Group Type: ACTIVE_COMPARATOR

Seri Surgical Scaffold

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Seri; Seri Scaffold

Eligibility Criteria

Inclusion Criteria

Age =>18 years

• requesting procedure
• No active cancer or infection

Exclusion Criteria

• Known allergy to silk
• Pregnant or lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan Medical

INDUSTRY

Sponsor Role: collaborator

Bengtson Center

OTHER

Sponsor Role: lead

Responsible Party

Bradley Bengtson, M.D.

Bradley P Bengtson, MD FACS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bradley P Bengtson, MD

Role: PRINCIPAL_INVESTIGATOR

Bengtson Center

Locations

Bengtson Center for Aesthetics and Plastic Surgery

Grand Rapids, Michigan, United States

Center for Aesthetics and Plastic Surgery

Grand Rapids, Michigan, United States

Countries

United States

Other Identifiers

007

Identifier Type: -

Identifier Source: org_study_id