Leak on Lineal Stapled AnastomosesPhase 4NCT01180140
Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
A Phase 4 study testing Seamguard in people with Leak on Lineal Stapled Anastomoses and Bleeding on Lineal Stapled Anastomoses, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Leak on Lineal Stapled Anastomoses, Bleeding on Lineal Stapled Anastomoses
- What is being tested?
- Seamguard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2006to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who will need a lineal stapled anastomoses (colon cancer in cecum, for example)
Who cannot join
- circular anastomoses
- bariatric surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
About this study
Official title: Use of Seamguard to Prevent Digestive Leak and Bleeding on Lineal Stapled Anastomoses: a Prospective Randomized Clinical Trial
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.
- Being tested
- Seamguard
- Keywords
- Seamguard, staple-line reinforcement, leak, bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeamguardDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | without seamguard |
| 2 | Experimental | with seamguard Receives: Device: Seamguard |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startMar 2006
- Primary completionAug 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leak on Lineal Stapled AnastomosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Collaborators
- Unidad mixta de Investigación HUC-ULL, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180140
- Sponsor's protocol ID
- Seamguard Study
- Status last verified
- Aug 2010
- First submitted
- 18 Jul 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Seamguard to Prevent Digestive Leak and Bleeding on Lineal Stapled Anastomoses: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01180140
- Acronym / sponsor ID
- Seamguard Study
- Keywords
- Seamguard, staple-line reinforcement, leak, bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Collaborators
- Unidad mixta de Investigación HUC-ULL, University of La Laguna
- Study start
- Mar 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –without seamguard |
| 2 | Experimental | Device: Seamguardwith seamguard |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who will need a lineal stapled anastomoses (colon cancer in cecum, for example)
Key exclusion criteria (2 listed)
- circular anastomoses
- bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeamguardGORE 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. | Device | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Seamguard in people with Leak on Lineal Stapled Anastomoses and Bleeding on Lineal Stapled Anastomoses, run by Hospital Universitario de Canarias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2010.