Study to Evaluate the Performance of a Sustained Vacuum System
NCT04554407 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2021-09-28
Summary
The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.
Conditions
- Seroma as Procedural Complication
- Hematoma Postoperative
Interventions
- DEVICE
-
SOMAVAC® 100 Sustained Vacuum System
The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.
Sponsors & Collaborators
-
University of Tennessee
collaborator OTHER -
SOMAVAC Medical Solutions
lead INDUSTRY
Principal Investigators
-
Martin D Fleming, MD · University of Tennessee
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-08-11
- Primary Completion
- 2022-09-30
- Completion
- 2022-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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