MedTrace Logo

SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery

NCT02030938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-12-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Subjects Requiring Revision Breast Augmentation Surgery

Interventions

DEVICE

SERI® Surgical Scaffold

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

Sponsors & Collaborators

  • Sofregen Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Gabriel Kind · Kind Chang Plastic Surgery - California Pacific Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02030938 on ClinicalTrials.gov