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

NCT01867658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2017-03-29

Study results available
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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.

Conditions

  • Pulmonary Disease

Interventions

DEVICE

Progel® Pleural Air Leak Sealant

Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Bernard Park, MD · Hackensack Meridian Health

  • John Snider, MD · Dean Foundation for Health, Research and Education, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867658 on ClinicalTrials.gov