Trials / Completed
CompletedNCT01180140
Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
Use of Seamguard to Prevent Digestive Leak and Bleeding on Lineal Stapled Anastomoses: a Prospective Randomized Clinical Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Hospital Universitario de Canarias · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determinate the utility of staple-line reinforcement on lineal gastrointestinal anastomoses. Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive lineal stapled anastomoses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Seamguard | GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. Then, after six months, it is completely absorbed eliminating the risk of a prolonged inflammatory response. |
Timeline
- Start date
- 2006-03-01
- Primary completion
- 2009-08-01
- Completion
- 2010-06-01
- First posted
- 2010-08-11
- Last updated
- 2010-08-11
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01180140. Inclusion in this directory is not an endorsement.