NCT01867658

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	Progel® Pleural Air Leak Sealant	Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-06-04
• Last updated: 2017-03-29
• Results posted: 2016-11-11

Locations

15 sites across 1 country: United States