NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

Not Applicable

Completed

• Conditions: Lung Tumor; Lung Cancer

• Registration Number: NCT01394978
• Lead Sponsor: C. R. Bard

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-15
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2017-04-17
• Results First Submitted QC: 2017-06-09
• Results First Posted: 2017-07-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 444

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety Endpoints	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

Trial Locations

Locations (18)

St. Vincent Birmingham & St. Vincent East; 🇺🇸 Birmingham, Alabama, United States

University of Alabama in Birmingham; 🇺🇸 Birmingham, Alabama, United States

Jacksonville Center for Research; 🇺🇸 Jacksonville, Florida, United States

Moffit Cancer Center; 🇺🇸 Tampa, Florida, United States

WellStar Research Institute; 🇺🇸 Atlanta, Georgia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

St. Vincent Hospital and Health Care Center; 🇺🇸 Indianapolis, Indiana, United States

Greater Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States

Mass General Hospital; 🇺🇸 Boston, Massachusetts, United States

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