CClinicalTrials.gg
CompletedNCT01180140Updated Aug 11, 2010

Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

A Phase 4 interventional study of Seamguard in Leak on Lineal Stapled Anastomoses and Bleeding on Lineal Stapled Anastomoses, sponsored by Hospital Universitario de Canarias. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-08-11.

Sponsored by Hospital Universitario de Canarias · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Leak on Lineal Stapled Anastomoses
  • Bleeding on Lineal Stapled Anastomoses

Browse trials for

Keywords

  • Seamguard
  • staple-line reinforcement
  • leak
  • bleeding
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 113 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Hospital Universitario de Canarias is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients who will need a lineal stapled anastomoses (colon cancer in cecum, for example)

Exclusion criteria

Exclusion Criteria:

  • circular anastomoses
  • bariatric surgery
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
113 participants (actual)

Study arms

  • No intervention
    1

    without seamguard

  • Experimental
    2

    with seamguard

    Device: Seamguard

Interventions

  • DeviceSeamguard

    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.

06

Study locations

1 site
  • Hospital Universitario de Canarias
    La Laguna, Santa Cruz de Tenerife 38320, Spain
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01180140
Lead sponsor
Hospital Universitario de Canarias
Collaborators
Unidad mixta de Investigación HUC-ULL, University of La Laguna
First posted
Aug 11, 2010
Start date
Mar 2006
Primary completion
Aug 2009
Completion
Jun 2010
Last update
Aug 11, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion