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

Primary Purpose

Recurrent Ptosis of the Breast

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Seri Surgical Scaffold

About this trial

This is an interventional prevention trial for Recurrent Ptosis of the Breast focused on measuring Recurrent, Ptosis, Reduction, Mammoplasty, Mastopexy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Age =>18 years

requesting procedure
No active cancer or infection

Exclusion Criteria:

Known allergy to silk
Pregnant or lactating

Sites / Locations

Bengtson Center for Aesthetics and Plastic Surgery
Center for Aesthetics and Plastic Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Reduction, Mastopexy No Implant, No Seri

Mastopexy, Implant no Seri Scaffold

Breast Reduction with Seri Support

Augmentation Mastopexy, Implant and Seri

Arm Description

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

Mastopexy with implant, No Seri Surgical Scaffold support is used

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

Augmentation Mastopexy patients where Seri Surgical scaffold is used

Outcomes

Primary Outcome Measures

Nipple to Fold Measurement on Stretch

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

Secondary Outcome Measures

Percent Breast Tissue Above Nipple

The percentage of breast tissue above and below the horizontal plane of the nipple over time

Full Information

NCT ID

NCT02016612

First Posted

December 16, 2013

Last Updated

January 17, 2018

Sponsor

Bengtson Center

Collaborators

Allergan Medical

1. Study Identification

Unique Protocol Identification Number

NCT02016612

Brief Title

Seri Surgical Scaffold Support of the Lower Pole of the Breast

Acronym

SeriSupport

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bengtson Center

Collaborators

Allergan Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Ptosis of the Breast

Keywords

Recurrent, Ptosis, Reduction, Mammoplasty, Mastopexy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reduction, Mastopexy No Implant, No Seri

Arm Type

Active Comparator

Arm Description

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

Arm Title

Mastopexy, Implant no Seri Scaffold

Arm Type

Active Comparator

Arm Description

Mastopexy with implant, No Seri Surgical Scaffold support is used

Arm Title

Breast Reduction with Seri Support

Arm Type

Active Comparator

Arm Description

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

Arm Title

Augmentation Mastopexy, Implant and Seri

Arm Type

Active Comparator

Arm Description

Augmentation Mastopexy patients where Seri Surgical scaffold is used

Intervention Type

Device

Intervention Name(s)

Seri Surgical Scaffold

Other Intervention Name(s)

Seri, Seri Scaffold

Intervention Description

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

Primary Outcome Measure Information:

Title

Nipple to Fold Measurement on Stretch

Description

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

Time Frame

1 year post op

Secondary Outcome Measure Information:

Title

Percent Breast Tissue Above Nipple

Description

The percentage of breast tissue above and below the horizontal plane of the nipple over time

Time Frame

1 year post op

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age =>18 years requesting procedure No active cancer or infection Exclusion Criteria: Known allergy to silk Pregnant or lactating

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bradley P Bengtson, MD

Organizational Affiliation

Bengtson Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bengtson Center for Aesthetics and Plastic Surgery

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Center for Aesthetics and Plastic Surgery

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Seri Surgical Scaffold Support of the Lower Pole of the Breast

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