Study to Evaluate the Performance of a Sustained Vacuum System

NCT04554407 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-09-28

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04554407 on ClinicalTrials.gov