Back to resultsLifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
LifeSeal™ Kit
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
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
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
LifeSeal™ Kit
Arm Description
Standard of Care Arm - subjects treated by routine manner
LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment
Outcomes
Primary Outcome Measures
Assessment of subject's safety by incidence of related Adverse Events
Secondary Outcome Measures
Assessment of the device's application technique
Surgeon will complete a questionnaire regarding the device use and ease of application
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01790230
Brief Title
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
Official Title
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeBond Ltd.
4. Oversight
5. Study Description
Brief Summary
A preliminary Study in Subjects Undergoing Low Anterior Resection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care Arm - subjects treated by routine manner
Arm Title
LifeSeal™ Kit
Arm Type
Experimental
Arm Description
LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment
Intervention Type
Device
Intervention Name(s)
LifeSeal™ Kit
Intervention Description
Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection
Primary Outcome Measure Information:
Title
Assessment of subject's safety by incidence of related Adverse Events
Time Frame
Approx. 1 month
Secondary Outcome Measure Information:
Title
Assessment of the device's application technique
Description
Surgeon will complete a questionnaire regarding the device use and ease of application
Time Frame
Intra-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
12. IPD Sharing Statement
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LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
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