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NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

NCT01394978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2021-07-15

Study results available
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Summary

The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.

Conditions

Interventions

OTHER

Control

Standard surgical techniques including staples and sutures.

DEVICE

ProGEL Pleural Air Leak Sealant with standard surgical closure

ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.

DEVICE

ProGEL Pleural Air Leak Sealant without standard surgical closure

ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Robert J. Cerfolio, MD · University of Alabama in Birmingham

  • Daniel L. Miller, MD · WellStar Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

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 NCT01394978 on ClinicalTrials.gov