NCT04068545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

August 22, 2019

Last Update Submit

July 16, 2020

Conditions

Pulmonary Air Leak

Outcome Measures

Primary Outcomes (1)

  • Device User Experience Survey

    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.

    At study completion - approximate 6 months.

Interventions

Device: Thoraguard Surgical Drainage SystemDEVICE

Fluid drainage following thoracic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-emergent thoracic surgery patients undergoing a procedure for one of the following: pulmonary resection, pneumectomy, or lobectomy.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

Related Publications (3)

  • McGuire AL, Petrcich W, Maziak DE, Shamji FM, Sundaresan SR, Seely AJ, Gilbert S. Digital versus analogue pleural drainage phase 1: prospective evaluation of interobserver reliability in the assessment of pulmonary air leaks. Interact Cardiovasc Thorac Surg. 2015 Oct;21(4):403-7. doi: 10.1093/icvts/ivv128. Epub 2015 Jul 14.

    PMID: 26174120BACKGROUND

  • Pompili C, Detterbeck F, Papagiannopoulos K, Sihoe A, Vachlas K, Maxfield MW, Lim HC, Brunelli A. Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.

    PMID: 24906602BACKGROUND

  • Miller DL, Helms GA, Mayfield WR. Digital Drainage System Reduces Hospitalization After Video-Assisted Thoracoscopic Surgery Lung Resection. Ann Thorac Surg. 2016 Sep;102(3):955-961. doi: 10.1016/j.athoracsur.2016.03.089. Epub 2016 May 25.

    PMID: 27234573BACKGROUND

Study Officials

  • Michael Zervos, MD

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

September 2, 2019

Primary Completion

March 30, 2020

Study Completion

May 30, 2020

Last Updated

July 17, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)