Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
NCT02033590 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2017-10-09
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.
Conditions
- Breast Reconstruction
Interventions
- DEVICE
-
Biodegradable (purified) surgical silk scaffold
Sponsors & Collaborators
-
Sofregen Medical, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-08-31
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