Experiences With New Digital Surgical Drainage System in Thoracic Surgery
|ClinicalTrials.gov Identifier: NCT04068545|
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2019
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment|
|Pulmonary Air Leak||Device: Device: Thoraguard Surgical Drainage System|
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 collection canister and drainage line) which connect to a proprietary chest tube but may also connect to other thoracic drainage catheters. The system continuously monitors line patency, automatically clears the chest tube (when used with Thoraguard Chest Tube) and drainage line from build-up, and provides digital readings of fluid output trends. The system is battery powered with integrated suction for ease of ambulation.
Additionally, the system has patient safety alarms to notify clinical staff of unexpected events associated with postoperative drainage. These functions offer significant improvements over the current standard of care. Reliable post-operative drainage, reduced workload, and decreased variability in chest tube maintenance procedures have the potential to increase patient safety, reduce complications, and improve the patient experience.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Experiences With New Digital Surgical Drainage System in Thoracic Surgery|
|Actual Study Start Date :||September 2, 2019|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||April 30, 2020|
- Device: Device: Thoraguard Surgical Drainage System
Fluid drainage following thoracic surgery
- Device User Experience Survey [ Time Frame: At study completion - approximate 6 months. ]The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the Thoraguard Surgical Drainage System. The questionnaire asks approximately 15 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating clinicians at the completion of the study. A summary of all treating clinician responses will be generated at the completion of the study to summarize the overall user experience with the device.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068545
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Michael Zervos, MD||NYU Langone Medical Center|