Experiences With New Digital Surgical Drainage System in Thoracic Surgery

Completed

Conditions studied: Pulmonary Air Leak

In brief

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 the current standard of care system for the removal of surgical fluids and air following thoracic surgery. Observations, experiences, and outcomes in a single hospital setting will be collected for the Thoraguard Surgical Drainage System.

Key facts

Study ID

NCT04068545

Run by

Centese, Inc.

People needed

30

Starts

2019-09-02

Expected to finish

2020-05-30

Last updated by the study team

2020-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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