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Completed

NCT Number: NCT01394978

NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

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 information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Lung Tumor Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent Birmingham & St. Vincent East, Birmingham, Alabama, United States

Loading trial locations.

About this study

Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Exclusion 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

Treatment and study plan

Control

Other

Standard surgical techniques including staples and sutures.

ProGEL Pleural Air Leak Sealant with standard surgical closure

Device

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.

ProGEL Pleural Air Leak Sealant without standard surgical closure

Device

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.

Primary outcomes

  1. Safety Endpoints

    Time frame: 90 days

    • Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome
    • Renal adverse events
    • Cardiac adverse events
    • Death (all causes)
    • Hospital readmission

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2011
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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