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NCT01394978 · ClinicalTrials.gov registry record · NA
NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
A NA study, sponsored by C. R. Bard.
- Completed
- Registry status
- NA
- Development phase
- 444
- Enrollment target
NCT01394978: Completed NA study, sponsored by C. R. Bard.
NCT01394978 is a NA study that has completed, run by C. R. Bard. The registered enrollment target is 444 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01394978, a NA study, has completed, sponsored by C. R. Bard.
- COMPLETED
- Registry status
- NA
- Development phase
- 444 participants
- Enrollment target
Study 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.
Primary Outcome
* 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
Interventions
- OTHER Control
- DEVICE ProGEL Pleural Air Leak Sealant with standard surgical closure
- DEVICE ProGEL Pleural Air Leak Sealant without standard surgical closure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT01394978 record still lists
NCT01394978 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Control is the first listed.
NCT01394978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01394978 about?
NCT01394978 is a clinical study titled "NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study". 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.
What is the current status of trial NCT01394978?
This trial is currently completed. It is a NA study. The enrollment target is 444 participants. The study started on 2011-06. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01394978?
The interventions under investigation include: Control (OTHER), ProGEL Pleural Air Leak Sealant with standard surgical closure (DEVICE), ProGEL Pleural Air Leak Sealant without standard surgical closure (DEVICE).
Who is sponsoring clinical trial NCT01394978?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01394978's enrollment target sits among peer trials
444 233rd of 2000 higher than 1,768 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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