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

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ClinicalTrials.gov Identifier: NCT02033590
Recruitment Status : Withdrawn (Strategic priorities impacted study)
First Posted : January 13, 2014
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Sofregen Medical, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Reconstruction Device: Biodegradable (purified) surgical silk scaffold Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SERI® Surgical Scaffold Device: Biodegradable (purified) surgical silk scaffold



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


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

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