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

This study has been withdrawn prior to enrollment.
(Strategic priorities impacted study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02033590
First Posted: January 13, 2014
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sofregen Medical, Inc.
  Purpose
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.

Condition Intervention
Breast Reconstruction Device: Biodegradable (purified) surgical silk scaffold

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sofregen Medical, Inc.:

Primary Outcome Measures:
  • Incidence rate of implant loss (SERI® and breast implant) [ Time Frame: 52 weeks ]

Enrollment: 0
Actual Study Start Date: July 2014
Study Completion Date: August 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SERI® Surgical Scaffold Device: Biodegradable (purified) surgical silk scaffold

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Sofregen Medical, Inc.
ClinicalTrials.gov Identifier: NCT02033590     History of Changes
Other Study ID Numbers: SURE-005
First Submitted: January 9, 2014
First Posted: January 13, 2014
Last Update Posted: October 9, 2017
Last Verified: October 2017