NCT04068545

Experiences With New Digital Surgical Drainage System in Thoracic Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Centese, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Pulmonary Air Leak

Interventions

Type	Name	Description
DEVICE	Device: Thoraguard Surgical Drainage System	Fluid drainage following thoracic surgery

Timeline

• Start date: 2019-09-02
• Primary completion: 2020-03-30
• Completion: 2020-05-30
• First posted: 2019-08-28
• Last updated: 2020-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study