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NCT01867658 · ClinicalTrials.gov registry record · NA
Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
A NA study, sponsored by C. R. Bard.
- Completed
- Registry status
- NA
- Development phase
- 207
- Enrollment target
NCT01867658: Completed NA study, sponsored by C. R. Bard.
NCT01867658 is a NA study that has completed, run by C. R. Bard. The registered enrollment target is 207 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01867658, a NA study, has completed, sponsored by C. R. Bard.
- COMPLETED
- Registry status
- NA
- Development phase
- 207 participants
- Enrollment target
Study Summary
The objective of this clinical study is to evaluate the safety of the Progel® PALS, including the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative air leaks in patients undergoing video assisted or robotic assisted thoracoscopic (VATS/Robotic) surgeries. The data collected in this clinical study will supplement the Approved PMA P010047 Progel® PALS product.
Primary Outcome
The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.
Interventions
- DEVICE Progel® Pleural Air Leak Sealant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-04 |
| Phase | NA |
What the finished NCT01867658 record still lists
NCT01867658 is an interventional study that assigns participants to a tested intervention. The registered 207 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 (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Progel® Pleural Air Leak Sealant is the first listed.
NCT01867658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01867658 about?
NCT01867658 is a clinical study titled "Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery". The objective of this clinical study is to evaluate the safety of the Progel® PALS, including the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative air leaks in patients undergoing video assisted or robotic assisted thoracoscopic (VATS/Robotic) surgeries. The data collec...
What is the current status of trial NCT01867658?
This trial is currently completed. It is a NA study. The enrollment target is 207 participants. The study started on 2013-06. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01867658?
The interventions under investigation include: Progel® Pleural Air Leak Sealant (DEVICE).
Who is sponsoring clinical trial NCT01867658?
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 NCT01867658's enrollment target sits among peer trials
207 499th of 2000 higher than 1,502 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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