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SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction

NCT01914653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-10-09

No results posted yet for this study

Summary

Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.

Conditions

  • Breast Reconstruction

Interventions

DEVICE

Silk surgical mesh

A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair

Sponsors & Collaborators

  • Sofregen Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan Medical

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Israel

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 NCT01914653 on ClinicalTrials.gov