LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
NCT ID: NCT01790230
Last Updated: 2013-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2013-01-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
Standard of Care Arm - subjects treated by routine manner
No interventions assigned to this group
LifeSeal™ Kit
LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment
LifeSeal™ Kit
Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection
Interventions
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LifeSeal™ Kit
Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection
Eligibility Criteria
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Inclusion Criteria
2. Subject is at least 18 years of age
3. Subject is scheduled for elective open resection
4. Stapled anastomosis created within 10cm of the anal verge
5. Subject is willing to comply with the follow-up requirements of the study
Exclusion Criteria
2. Subject has unacceptable baseline hematological results
3. Subject on chronic preoperative treatment with steroids and anticoagulants
4. Subject with elevated liver function tests
5. Subject with abnormal kidney function
6. Subject with a BMI higher than 35
7. Subject participating in any other study for either drug or device which can influence collection of valid data under this study
8. Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year
9. Anastomosis was performed differently from what was defined
10. Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™
11. Subject has intraoperative bleeding in excess of 500cc
12. Subject has peritoneal carcinomatosis
18 Years
ALL
No
Sponsors
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LifeBond Ltd.
INDUSTRY
Responsible Party
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Locations
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Uppsala University Hospital
Uppsala, , Sweden
Countries
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Other Identifiers
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CLP-LS-0105
Identifier Type: -
Identifier Source: org_study_id