CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 444 enrolled
Drug / intervention
Control +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01394978
NCT01394978N/ACompleted
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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

C. R. Bard·interventional·Posted Jul 15, 2011·Updated Jul 15, 2021

In Brief

A clinical study evaluating Control, ProGEL Pleural Air Leak Sealant with standard surgical closure, and 1 other intervention for Lung Cancer and Lung Tumor. Completed, enrolled 444 participants across 18 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Lung Tumor
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 15, 2011
Enrollment StartJun 1, 2011
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 15.0 years ago

Interventions

Controlother

Standard surgical techniques including staples and sutures.

ProGEL Pleural Air Leak Sealant with standard surgical closuredevice

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 closuredevice

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.