NCT02030938

SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Sofregen Medical, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.

Detailed description

This is a single arm prospective study. Approximately 4 investigational sites will enroll and follow subjects who meet the study criteria.The study will span a total of approximately 18 months: an estimated 6 months for recruitment and 12 months for follow up. 50 subjects will be enrolled in the study. It is anticipated that given an average of 1.5 operated breasts per subject enrolled for Revision Augmentation surgery that 75 implantations of SERI® surgical scaffold will occur.

Conditions

• Subjects Requiring Revision Breast Augmentation Surgery

Interventions

Type	Name	Description
DEVICE	SERI® Surgical Scaffold	Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-01-09
• Last updated: 2021-12-28
• Results posted: 2021-12-28

Locations

5 sites across 1 country: United States