Evaluation of SOMAVAC 100 Sustained Vacuum System
NCT04845256 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25
Last updated 2023-02-13
Summary
The purpose of this research study is to compare the effectiveness of the Somavac 100 Sustained Vacuum System versus manual section bulbs after immediate breast reconstruction.
Conditions
Interventions
- DEVICE
-
SOMAVAC 100 Sustained Vacuum System
Evaluate performance of sustained vacuum system compared to manual suction bulbs
Sponsors & Collaborators
-
University of Tennessee
lead OTHER
Principal Investigators
-
Mark A Brzezienski, MD · University of Tennessee College of Medicine Chattanooga, Department of Plastic Surgery
Eligibility
- Min Age
- 21 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-01
- Primary Completion
- 2022-10-05
- Completion
- 2022-10-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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