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CompletedNot applicableNCT01394978
Official study title

NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedControl and ProGEL Pleural Air Leak Sealant with standard surgical closure

Plus 1 other study approaches.

Who it may be forLung Cancer · Lung Tumor

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 15, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?C. R. Bard

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
C. R. Bard
Interventions being studied
Other: Control; Device: ProGEL Pleural Air Leak Sealant with standard surgical closure; Device: ProGEL Pleural Air Leak Sealant without standard surgical closure
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Scheduled for an open thoracotomy for lung resection
  • Has at least one or more intraoperative visible air leak \>= 2 mm following the lung resection surgery
Reasons someone may not be able to joinExclusion criteria
  • Pregnant or breast feeding
  • History of an allergic reaction to Human Serum Albumin
  • Has a significant clinical disease or condition
  • Had previous open thoracotomy procedures
  • Unable to participate in all necessary study activities due to physical or mental limitations

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • St. Vincent Birmingham & St. Vincent EastBirmingham, Alabama
  • University of Alabama in BirminghamBirmingham, Alabama
  • Jacksonville Center for ResearchJacksonville, Florida
  • Moffit Cancer CenterTampa, Florida
  • WellStar Research InstituteAtlanta, Georgia
  • Emory UniversityAtlanta, Georgia
  • Indiana UniversityIndianapolis, Indiana
  • St. Vincent Hospital and Health Care CenterIndianapolis, Indiana
  • Greater Baltimore Medical CenterBaltimore, Maryland
  • Mass General HospitalBoston, Massachusetts
  • Brigham Womens' HospitalBoston, Massachusetts
  • Beth Israel Deconess Medical CenterBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 15, 2021. Always confirm current availability with the study team.

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