Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction

October 5, 2017 updated by: Sofregen Medical, Inc.
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Be willing to undergo immediate breast reconstruction following a skin-sparing or nipple sparing mastectomy with healthy, sufficiently thick, well-vascularized skin flaps, and the implantation of SERI® Surgical Scaffold and breast implant
  • Be female, between 18 and 65 years of age at the time of enrollment

Exclusion Criteria:

  • Have undergone prior radiation treatment on the study breast(s) and/or is preoperatively evaluated to require radiation treatment to the study breast(s) during the course of the study
  • Have undergone a skin reducing mastectomy
  • Have a BMI that is <17 or ≥ 30
  • Predicted implant weight more than 500 grams
  • Have a known allergy to silk
  • Have an abscess or active infection at any location within one month prior to surgery
  • Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SERI® Surgical Scaffold
Device: Biodegradable (purified) surgical silk scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of implant loss (SERI® and breast implant)
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sofregen Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2014

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (ESTIMATE)

January 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • SURE-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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