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Seri Surgical Scaffold Support of the Lower Pole of the Breast

NCT02016612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2018-02-13

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Allergan Medical

    collaborator INDUSTRY

  • Bengtson Center

    lead OTHER

Principal Investigators

  • Bradley P Bengtson, MD · Bengtson Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02016612 on ClinicalTrials.gov