N/A N=444 Treatment

NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

Lung Cancer · Lung Tumor

Bottom Line

View on ClinicalTrials.gov: NCT01394978 ↗

Enrolled (actual)

444

Serious AEs

23.4%

Results posted

Jul 2017

Primary outcome: Primary: Safety Endpoints — 22; 48; 25; 40 Events

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Control (Other); ProGEL Pleural Air Leak Sealant with standard surgical closure (Device); ProGEL Pleural Air Leak Sealant without standard surgical closure (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: C. R. Bard
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety Endpoints	22; 48; 25; 40; 1; 6	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01394978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.