Back to resultsProgel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
Primary Purpose
Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progel® Pleural Air Leak Sealant
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease focused on measuring Pleural Air Leak, Pulmonary resection, Video Assisted, Robotic Assisted
Eligibility 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.
Sites / Locations
- Cardiothoracic & Vascular Surgical Associates, PA
- Jupiter Medical Center, Inc.
- Baptist Hospital of Miami
- H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
- North Shore University Health System
- Mayo Clinic
- Washington University
- Integrated Cardiology Group, LLC
- Hackensack University Medical Center
- Trustees of Columbia University, NY - Presbyterian Hospital
- Greenville Hospital System
- Baylor Research Institute
- University of Texas Southwestern Medical Center
- INOVA Health Care Services
- Dean Foundation for Health, Research, and Eduation, Inc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Progel® Pleural Air Leak Sealant
Arm Description
Outcomes
Primary Outcome Measures
Rate of Device and/or Procedure-related Adverse Events
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
Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up
Percentage of Air Leaks That Are Sealed or Reduced
Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery
Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals
Duration of Chest Tube Drainage
Duration of Hospitalization (Length of Stay)
Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01867658
Brief Title
Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease
Keywords
Pleural Air Leak, Pulmonary resection, Video Assisted, Robotic Assisted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Progel® Pleural Air Leak Sealant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Progel® Pleural Air Leak Sealant
Intervention Description
Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
Primary Outcome Measure Information:
Title
Rate of Device and/or Procedure-related Adverse Events
Description
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.
Time Frame
One (1) month follow-up
Secondary Outcome Measure Information:
Title
Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up
Time Frame
One (1) month
Title
Percentage of Air Leaks That Are Sealed or Reduced
Time Frame
Day 0
Title
Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery
Time Frame
Day 0
Title
Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals
Time Frame
Day 0-46
Title
Duration of Chest Tube Drainage
Time Frame
Day 0-46
Title
Duration of Hospitalization (Length of Stay)
Time Frame
Days 0-20
Title
Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up
Description
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.
Time Frame
Baseline and One (1) Month Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Park, MD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Snider, MD
Organizational Affiliation
Dean Foundation for Health, Research and Education, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiothoracic & Vascular Surgical Associates, PA
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Jupiter Medical Center, Inc.
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
City
Tampa
State/Province
Florida
Country
United States
Facility Name
North Shore University Health System
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Integrated Cardiology Group, LLC
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Trustees of Columbia University, NY - Presbyterian Hospital
City
New York City
State/Province
New York
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
INOVA Health Care Services
City
Falls Church
State/Province
Virginia
Country
United States
Facility Name
Dean Foundation for Health, Research, and Eduation, Inc
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27955681
Citation
Park BJ, Snider JM, Bates NR, Cassivi SD, Jett GK, Sonett JR, Toloza EM. Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks. J Cardiothorac Surg. 2016 Dec 12;11(1):168. doi: 10.1186/s13019-016-0563-3.
Results Reference
derived
Learn more about this trial
Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
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