Status:
COMPLETED
Experiences With New Digital Surgical Drainage System in Thoracic Surgery
Lead Sponsor:
Centese, Inc.
Collaborating Sponsors:
NYU Langone Health
Conditions:
Pulmonary Air Leak
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 and drainage kit (fluid c...
Eligibility Criteria
Inclusion
- Adult (age ≥ 18)
- Patient undergoing non-emergent thoracic surgery (Sternotomy, Video-Assisted Thoracoscopic Surgery (VATS), Thoracotomy, or Robotic)
- Expected requirement for chest drain monitoring of air leak for at least 24h post-operation
- A requirement for a surgical drainage system
Exclusion
- Emergency surgery
- Re-do surgery
- Prior thoracic surgery
- Transplant Surgery
- 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 :
September 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04068545
Start Date
September 2 2019
End Date
May 30 2020
Last Update
July 17 2020
Active Locations (1)
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1
NYU School of Medicine
New York, New York, United States, 10016