Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery

A Prospective Multi-Center Clinical Study to Evaluate the Safety of Progel® Pleural Air Leak Sealant in Video Assisted and Robotic Assisted Thoracotomy Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease
• Intervention / Treatment: Device: Progel® Pleural Air Leak Sealant

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.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States
      • Cardiothoracic & Vascular Surgical Associates, PA
    • Jupiter, Florida, United States
      • Jupiter Medical Center, Inc.
    • Miami, Florida, United States
      • Baptist Hospital of Miami
    • Tampa, Florida, United States
      • H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
  • Illinois
    • Evanston, Illinois, United States
      • North Shore University Health System
  • Minnesota
    • Rochester, Minnesota, United States
      • Mayo Clinic
  • Missouri
    • St. Louis, Missouri, United States
      • Washington University
  • Nebraska
    • Lincoln, Nebraska, United States
      • Integrated Cardiology Group, LLC
  • New Jersey
    • Hackensack, New Jersey, United States
      • Hackensack University Medical Center
  • New York
    • New York City, New York, United States
      • Trustees of Columbia University, NY - Presbyterian Hospital
  • South Carolina
    • Greenville, South Carolina, United States
      • Greenville Hospital System
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Research Institute
    • Dallas, Texas, United States
      • University of Texas Southwestern Medical Center
  • Virginia
    • Falls Church, Virginia, United States
      • Inova Health Care Services
  • Wisconsin
    • Madison, Wisconsin, United States
      • Dean Foundation for Health, Research, and Eduation, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One (1) month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up		One (1) month
Percentage of Air Leaks That Are Sealed or Reduced		Day 0
Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery		Day 0
Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals		Day 0-46
Duration of Chest Tube Drainage		Day 0-46
Duration of Hospitalization (Length of Stay)		Days 0-20
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.	Baseline and One (1) Month Follow-up

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Bernard Park, MD, Hackensack Meridian Health; Principal Investigator: John Snider, MD, Dean Foundation for Health, Research and Education, Inc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Pulmonary resection; Pleural Air Leak; Video Assisted; Robotic Assisted
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: NEO12-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No