CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 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/NCT02030938
NCT02030938N/ACompleted
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SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery

Sofregen Medical, Inc.·interventional·Posted Jan 9, 2014·Updated Dec 28, 2021

In Brief

A clinical study evaluating SERI® Surgical Scaffold for Subjects Requiring Revision Breast Augmentation Surgery. Completed, enrolled 34 participants across 5 sites.

Detailed Summary

An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubjects Requiring Revision Breast Augmentation Surgery
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 9, 2014
Enrollment StartDec 1, 2013
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.5 years ago

Interventions

SERI® Surgical Scaffolddevice

Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.