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

Breast Reconstruction Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02033590
• Other study ID #: SURE-005
• Status: Withdrawn
• Phase: N/A
• First received: January 9, 2014
• Last updated: October 5, 2017
• Start date: July 2014
• Est. completion date: August 2014

Study information

• Verified date: October 2017
• Source: Sofregen Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Device:
• Biodegradable (purified) surgical silk scaffold

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sofregen Medical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of implant loss (SERI® and breast implant)		52 weeks