SEAL Registry - European Registry for the Effectiveness o... | NCT02881359

Studies
SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit

NCT02881359

Sponsor

LifeBond Ltd.

Status

Unknown status

Last Update Posted

Apr 2, 2018Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Anastomotic Leakage

Interventions

LifeSeal® Kit

Countries

Belgium
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Aug 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Aug 23, 2016

First Submission Date that Met QC Criteria

Aug 23, 2016

First Posted Date

Aug 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2018

Last Update Posted Date

Apr 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LifeSeal® Kit		creation of a coloanal or colorectal anastomosis	Device: LifeSeal® Kit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LifeSeal® Kit	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of post-operative clinical anastomotic leaks at discharge		discharge from hospital 3-14 days post surgery

Secondary Outcomes

Measure	Description	Time Frame
Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery		up to 4 weeks post surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 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

Exclusion Criteria:

1. Subject with American Society of Anesthesiology (ASA) status > 3.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients who are treated with LifeSeal® and comply with the eligibility criteria will be offered to participate in the study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algemeen Stedelijk Ziekenhuis		Aalst		9300	Belgium
ZNA Antwerpen Campus

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057868	Anastomotic Leak

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided