At a glance

ClinicalIndex Comparison Record

N/ACompleted· 76 enrolled

Drug / intervention

Seri Surgical Scaffolddevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02016612

NCT02016612N/ACompleted

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

Bengtson Center·interventional·Posted Dec 20, 2013·Updated Feb 13, 2018

In Brief

A clinical study evaluating Seri Surgical Scaffold for Recurrent Ptosis of the Breast. Completed, enrolled 76 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsRecurrent Ptosis of the Breast

CountriesUnited States

CollaboratorsAllergan Medical

Timeline

N/ACompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartOct 2013

First PostedDec 2013

Primary CompletionNov 2015

Study CompletionNov 2016

TodayJul 2026

First PostedDec 20, 2013

Enrollment StartOct 1, 2013

Primary CompletionNov 1, 2015

Study CompletionNov 30, 2016

TodayJul 2, 2026

Enrollment to primary: 2.1 yearsPosted 12.5 years ago

Interventions

Seri Surgical Scaffolddevice

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