Clinical trial · Interventional
NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
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
NCT01394978CI-TRIAL-00052706completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Tumor | Lung Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| ProGEL Pleural Air Leak Sealant without standard surgical closure | Device | — | UNRESOLVED |
| ProGEL Pleural Air Leak Sealant with standard surgical closure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Control
- description
- No treatment.
- interventionNames
- Other: Control
- type
- EXPERIMENTAL
- label
- ProGEL Pleural Air Leak Sealant with standard surgical closure
- description
- Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant.
- interventionNames
- Device: ProGEL Pleural Air Leak Sealant with standard surgical closure
- type
- EXPERIMENTAL
- label
- ProGEL Pleural Air Leak Sealant without standard surgical closure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.