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PleuraSeal Post Market Study (Europe)

NCT00704171 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2016-10-27

Study results available
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Summary

To further characterize the PleuraSeal Sealant System as compared to standard of care (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy and segmentectomy via open thoractomy.

Conditions

Interventions

PROCEDURE

Standard Tissue Closure Techniques

Standard Tissue Closure Techniques (sutures and staples only)

DEVICE

PleuraSeal Lung Sealant System

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Jennifer Doyle · Senior Director, Clinical Affairs at Covidien (formerly Confluent)

  • Paul De Leyn, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00704171 on ClinicalTrials.gov