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

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Progel® Pleural Air Leak Sealant


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progel® Pleural Air Leak Sealant<br> | Device: Progel® Pleural Air Leak Sealant<br>* Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pleural Air Leak, Pulmonary resection, Video Assisted, Robotic Assisted