LifeSeal™ Preliminary Study in Subjects Undergoing Low An... | NCT01790230

Studies
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

NCT01790230

Sponsor

LifeBond Ltd.

Status

Completed

Last Update Posted

Sep 4, 2013Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Rectal Cancer

Interventions

LifeSeal™ Kit

Countries

Sweden

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

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Jan 31, 2013

First Submission Date that Met QC Criteria

Feb 11, 2013

First Posted Date

Feb 13, 2013Estimated

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

Sep 1, 2013

Last Update Posted Date

Sep 4, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care	No Intervention	Standard of Care Arm - subjects treated by routine manner
LifeSeal™ Kit	Experimental	LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment	Device: LifeSeal™ Kit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LifeSeal™ Kit	Device	Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection	LifeSeal™ Kit

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of subject's safety by incidence of related Adverse Events		Approx. 1 month

Secondary Outcomes

Measure	Description	Time Frame
Assessment of the device's application technique	Surgeon will complete a questionnaire regarding the device use and ease of application	Intra-operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject, or authorized representative, signed a written Informed Consent
Subject is at least 18 years of age
Subject is scheduled for elective open resection
Stapled anastomosis created within 10cm of the anal verge
Subject is willing to comply with the follow-up requirements of the study

Exclusion Criteria:

Subject has a history of hypersensitivity to porcine derived gelatin or collagen
Subject has unacceptable baseline hematological results
Subject on chronic preoperative treatment with steroids and anticoagulants
Subject with elevated liver function tests
Subject with abnormal kidney function
Subject with a BMI higher than 35
Subject participating in any other study for either drug or device which can influence collection of valid data under this study
Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year
Anastomosis was performed differently from what was defined
Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™
Subject has intraoperative bleeding in excess of 500cc
Subject has peritoneal carcinomatosis

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

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University Hospital		Uppsala		SE-751 85	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided