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Experiences With New Digital Surgical Drainage System in Thoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068545
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2019
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
NYU Langone Health
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pulmonary Air Leak Device: Device: 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Device: Device: Thoraguard Surgical Drainage System
    Fluid drainage following thoracic surgery


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-emergent thoracic surgery patients undergoing a procedure for one of the following: pulmonary resection, pneumectomy, or lobectomy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068545


Locations
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United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Centese, Inc.
NYU Langone Health
Investigators
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Principal Investigator: Michael Zervos, MD NYU Langone Medical Center
Publications:
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Responsible Party: Centese, Inc.
ClinicalTrials.gov Identifier: NCT04068545    
Other Study ID Numbers: CRD-1675
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No