N/A
Completed N=112
Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
Source: ClinicalTrials.gov NCT01867658 ↗Enrolled (actual)
112
Serious AEs
25.0%
Results posted
Nov 2016
Primary outcomePrimary: Rate of Device and/or Procedure-related Adverse Events — 42.5 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Device and/or Procedure-related Adverse Events |
42.5 | — |
| SECONDARY Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up |
49.1 | — |
| SECONDARY Percentage of Air Leaks That Are Sealed or Reduced |
96.2 | — |
| SECONDARY Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery |
55 | — |
| SECONDARY Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals |
2.8 | — |
| SECONDARY Duration of Chest Tube Drainage |
4.3 | — |
| SECONDARY Duration of Hospitalization (Length of Stay) |
4.6 | — |
| SECONDARY Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up |
-0.2; -6.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01867658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.