Experiences With New Digital Surgical Drainage System in Thoracic Surgery

Completed

• Conditions: Pulmonary Air Leak

• Registration Number: NCT04068545
• Lead Sponsor: Centese, Inc.

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 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.

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-28
• Study Start: 2019-09-02
• Primary Completion: 2020-03-30
• Study Completion: 2020-05-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device User Experience Survey	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.

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States