Anastomotic LeakageNCT02881359
SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit
An observational study of Anastomotic Leakage, run by LifeBond Ltd. at 8 sites in 2 countries.
Trial summary
This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leakage
- What is being tested?
- LifeSeal® Kit
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Oct 2016to Sep 2018
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who are treated with LifeSeal® and comply with the eligibility criteria will be offered to participate in the study.
Who may be able to join
- ≥ 18 years of age at screening visit
- Written informed consent obtained
- Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis* created within 15 cm from the anal verge.
- Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU
Who cannot join
- 1. Subject with American Society of Anesthesiology (ASA) status > 3.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Belgium7 sites
Algemeen Stedelijk Ziekenhuis
Aalst, 9300
ZNA Antwerpen Campus
Antwerp, 2060
Jessa Ziekenhuis
Hasselt
Jan Yperman Ziekenhuis
Ieper
CHR de la Citadelle
Liège, 4000
H. Hartziekenhuis
Mol, 2400
AZ Delta
Roeselare
About this study
Official title: SEAL Registry - Observational, Retrospective and Prospective, One Arm, Registry Study for the Effectiveness of LifeSeal® Kit on Anastomotic Leaks in Patients Undergoing Low and Ultralow Anterior Resection
This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate
Read the detailed description
The LifeSeal® Kit is a novel surgical sealant intended to be used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. The LifeSeal™ Kit has recently been CE certified on March 2016 for marketing in the European Union.
- Conditions
- Anastomotic Leakage
- Being tested
- LifeSeal® Kit
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeSeal® KitDevice
used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks.
| Study group | Role | What they receive |
|---|---|---|
| LifeSeal® Kit | creation of a coloanal or colorectal anastomosis Receives: Device: LifeSeal® Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative clinical anastomotic leaks at discharge
Measured: discharge from hospital 3-14 days post surgery
Secondary outcomes (1)
Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery
Measured: up to 4 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakageStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- LifeBond Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881359
- Sponsor's protocol ID
- CLP-LS-0146
- Status last verified
- Mar 2018
- First submitted
- 23 Aug 2016
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEAL Registry - Observational, Retrospective and Prospective, One Arm, Registry Study for the Effectiveness of LifeSeal® Kit on Anastomotic Leaks in Patients Undergoing Low and Ultralow Anterior Resection
- ClinicalTrials.gov ID
- NCT02881359
- Acronym / sponsor ID
- CLP-LS-0146
- Conditions
- Anastomotic Leakage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- LifeBond Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 29 Aug 2016 (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.
This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate
Detailed description
The LifeSeal® Kit is a novel surgical sealant intended to be used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. The LifeSeal™ Kit has recently been CE certified on March 2016 for marketing in the European Union.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LifeSeal® Kit | – | Device: LifeSeal® Kitcreation of a coloanal or colorectal anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are treated with LifeSeal® and comply with the eligibility criteria will be offered to participate in the study.
Key inclusion criteria (4 listed)
- ≥ 18 years of age at screening visit
- Written informed consent obtained
- Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis* created within 15 cm from the anal verge.
- Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU
Key exclusion criteria (1 listed)
- 1. Subject with American Society of Anesthesiology (ASA) status > 3.
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 |
|---|---|---|
| LifeSeal® Kitused as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. | Device | LifeSeal® Kit |
Primary outcome
Incidence of post-operative clinical anastomotic leaks at discharge
Time frame: discharge from hospital 3-14 days post surgery
1 secondary outcome
Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery
Time frame: up to 4 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Individual participant dataSharing planned: No
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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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leakage, run by LifeBond Ltd. at 8 sites in 2 countries.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Netherlands. 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.
Are results available for this study?
Results are not available in the source record.
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.
What does the primary outcome measure?
Incidence of post-operative clinical anastomotic leaks at discharge (time frame: discharge from hospital 3-14 days post surgery). It is what the study was designed to measure, not a finding.
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 2 Apr 2018.