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NCT01359410 · ClinicalTrials.gov registry record · NA
Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
A NA study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 112
- Enrollment target
NCT01359410 is a NA study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 112 participants.
The verdict
NCT01359410, a NA study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
Study Summary
The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm).
Interventions
- DEVICE Mesh reinforced staple line (SEAMGUARD)
- DEVICE Stapled without mesh reinforcement (PER-STRIPS DRY)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2007-06 |
| Est. Completion | 2011-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01359410
The ClinicalTrials.gov registry entry for NCT01359410 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mesh reinforced staple line (SEAMGUARD) is the first listed.
NCT01359410 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01359410 about?
NCT01359410 is a clinical study titled "Reinforced Staple Line on Leak Rate in Distal Pancreatectomy". The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonat...
What is the current status of trial NCT01359410?
This trial is currently terminated. It is a NA study. The enrollment target is 112 participants. The study started on 2007-06. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01359410?
The interventions under investigation include: Mesh reinforced staple line (SEAMGUARD) (DEVICE), Stapled without mesh reinforcement (PER-STRIPS DRY) (DEVICE).
Who is sponsoring clinical trial NCT01359410?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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