Status:
COMPLETED
Experiences With Automated Surgical Drainage in Cardiac Surgery
Lead Sponsor:
Centese, Inc.
Collaborating Sponsors:
Stanford University
Conditions:
Hemorrhage
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the Thoraguard Surgical Drainage System in a real-world clinical environment. It is believed that this system will offer functional and clinical benefits over ...
Detailed Description
The Thoraguard System is intended for use for drainage of blood, fluids, and gases following cardiac and thoracic surgery. The system consists of an electronic control module, drainage kit (fluid coll...
Eligibility Criteria
Inclusion
- Adult (age ≥ 18)
- Patient undergoing non-emergent cardiac surgery
- Anticipated requirement for mediastinal chest tube drainage
Exclusion
- Emergency surgery
- Re-do surgery
- Prior cardiac surgery
- Congenital cardiac disease or deformation
- Transplant surgery
- Ventricular Assist Device Surgery
- Suspected pulmonary air leak
- Atrial fibrillation
- In the opinion of the investigator the patient is unsuitable for the study for any other legitimate reason including incarceration, pre-existing medical or psychiatric condition, or interfering medications
- Known previous or concurrent enrollment in a clinical trial that, in the opinion of the investigator, might interfere with the objectives of this clinical trial
- Pregnancy
Key Trial Info
Start Date :
February 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03860363
Start Date
February 22 2019
End Date
May 30 2020
Last Update
July 17 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Stanford, California, United States, 94305