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Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic 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: NCT01867658
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : November 11, 2016
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:

The objective of this clinical study is to evaluate the safety of the Progel® PALS, including the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative air leaks in patients undergoing video assisted or robotic assisted thoracoscopic (VATS/Robotic) surgeries.

The data collected in this clinical study will supplement the Approved PMA P010047 Progel® PALS product.


Condition or disease Intervention/treatment Phase
Pulmonary Disease Device: Progel® Pleural Air Leak Sealant Not Applicable

Detailed Description:

This is a prospective, open label, multi-center clinical study designed to assess the safety of the Progel® PALS product, including the Extended Applicator Spray Tip, when used in Video Assisted and Robotic Assisted Thoracoscopic Surgery. The study will treat approximately 105 evaluable subjects at up to 15 U.S. sites. All subjects will provide informed consent prior to enrollment in the study.

Patients who have met the initial screening criteria and who have a visible pleural air leak which requires treatment with a sealant, after standard closure techniques are used (standard sutures, staples or devices supplied by the hospital for thoracoscopic surgery) will be eligible for study participation. If the subject is treated, the surgeon will utilize Progel® PALS to the same sites originally treated with standard technique.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multi-Center Clinical Study to Evaluate the Safety of Progel® Pleural Air Leak Sealant in Video Assisted and Robotic Assisted Thoracotomy Surgery
Study Start Date : June 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Progel® Pleural Air Leak Sealant Device: Progel® Pleural Air Leak Sealant
Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant




Primary Outcome Measures :
  1. Rate of Device and/or Procedure-related Adverse Events [ Time Frame: One (1) month follow-up ]
    The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.


Secondary Outcome Measures :
  1. Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up [ Time Frame: One (1) month ]
  2. Percentage of Air Leaks That Are Sealed or Reduced [ Time Frame: Day 0 ]
  3. Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery [ Time Frame: Day 0 ]
  4. Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals [ Time Frame: Day 0-46 ]
  5. Duration of Chest Tube Drainage [ Time Frame: Day 0-46 ]
  6. Duration of Hospitalization (Length of Stay) [ Time Frame: Days 0-20 ]
  7. Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up [ Time Frame: Baseline and One (1) Month Follow-up ]
    The scale ranges from 0 (minimum score) to 100 (maximum) score. A higher the score represents a more favorable health rating. The SF-36 was completed at baseline before surgery and one month post index procedure; the change calculation for both mental and physical components is based on the difference in scores between these two time points.



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
Criteria

Inclusion Criteria:

  • Subject is willing and able to provide written informed consent.
  • Subject is scheduled for video assisted or robotic assisted thoracoscopic surgery for lung resection (i.e. lobectomy, bilobectomy, segmentectomy, and wedge resection/lung volume reduction), decortications or biopsy within 45 days of the screening evaluation.
  • Subject is ≥18 years of age.
  • Subject has a life expectancy ≥6 months.
  • Following lung resection, subject has at least one or more visible intraoperative air leaks, after standard closure techniques are applied, that requires treatment with pleural sealant.
  • Subject is willing and able to comply with the study procedures and complete the entire study as specified in the protocol, including the follow-up visits.

Exclusion Criteria:

  • Subject has undergone previous lung resection or previous use of a sealant for air leaks.
  • Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis.
  • Following lung resection, subject has intraoperative air leaks that require non-standard, visceral pleural closure (e.g. leak is too small or tissue is too fragile to use sutures/staples).
  • Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
  • Subject has known allergy to human albumin or any component in the Progel® PALS product.
  • Subject has an active or latent infection which is systemic or at the intended surgery site.
  • Subject has necrotic or friable borders of the defect that will not support secure suture fixation if use of sutures is required.
  • Subject is participating in another investigational drug or device trial.
  • Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
  • Subject is part of the site personnel directly involved with this study.
  • Subject is a family member of the investigational study staff.

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): NCT01867658


Locations
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United States, Florida
Cardiothoracic & Vascular Surgical Associates, PA
Jacksonville, Florida, United States
Jupiter Medical Center, Inc.
Jupiter, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, United States
United States, Illinois
North Shore University Health System
Evanston, Illinois, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
United States, Missouri
Washington University
St. Louis, Missouri, United States
United States, Nebraska
Integrated Cardiology Group, LLC
Lincoln, Nebraska, United States
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States
United States, New York
Trustees of Columbia University, NY - Presbyterian Hospital
New York City, New York, United States
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, United States
United States, Virginia
INOVA Health Care Services
Falls Church, Virginia, United States
United States, Wisconsin
Dean Foundation for Health, Research, and Eduation, Inc
Madison, Wisconsin, United States
Sponsors and Collaborators
C. R. Bard
Investigators
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Principal Investigator: Bernard Park, MD Hackensack Meridian Health
Principal Investigator: John Snider, MD Dean Foundation for Health, Research and Education, Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01867658    
Other Study ID Numbers: NEO12-102
First Posted: June 4, 2013    Key Record Dates
Results First Posted: November 11, 2016
Last Update Posted: March 29, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by C. R. Bard:
Pleural Air Leak
Pulmonary resection
Video Assisted
Robotic Assisted
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases