N/A
Completed N=444
NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
Source: ClinicalTrials.gov NCT01394978 ↗Enrolled (actual)
444
Serious AEs
23.4%
Results posted
Jul 2017
Primary outcomePrimary: Safety Endpoints — 22; 48; 25; 40 Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Endpoints |
22; 48; 25; 40; 1; 6 | — |
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
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. Informational only — not medical advice.