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NCT00663819 · ClinicalTrials.gov registry record · NA
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
A NA study, sponsored by W.L.Gore & Associates.
- Terminated
- Registry status
- NA
- Development phase
- 258
- Enrollment target
NCT00663819: Clinical Trial NA study, sponsored by W.L.Gore & Associates.
NCT00663819 is a NA study that was terminated before completion, run by W.L.Gore & Associates. The registered enrollment target is 258 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00663819, a NA study, was terminated before completion, sponsored by W.L.Gore & Associates.
- TERMINATED
- Registry status
- NA
- Development phase
- 258 participants
- Enrollment target
Study Summary
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.
Primary Outcome
The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.
Interventions
- DEVICE GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
- PROCEDURE Staple line without reinforcement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-10 |
| Phase | NA |
Why NCT00663819 stopped before completion
NCT00663819 is an interventional study that assigns participants to a tested intervention. The registered 258 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 (82% lower).
The record links to 0 conditions, and to 2 interventions - of which GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement is the first listed.
NCT00663819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00663819 about?
NCT00663819 is a clinical study titled "Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses". The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileo...
What is the current status of trial NCT00663819?
This trial is currently terminated. It is a NA study. The enrollment target is 258 participants. The study started on 2008-04. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00663819?
The interventions under investigation include: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement (DEVICE), Staple line without reinforcement (PROCEDURE).
Who is sponsoring clinical trial NCT00663819?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00663819's enrollment target sits among peer trials
258 402nd of 2000 higher than 1,598 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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