Rectal Cancer Clinical Trial
Official title:
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
Verified date | September 2013 |
Source | LifeBond Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
A preliminary Study in Subjects Undergoing Low Anterior Resection
Status | Completed |
Enrollment | 10 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subject, or authorized representative, signed a written Informed Consent 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: 1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Uppsala University Hospital | Uppsala |
Lead Sponsor | Collaborator |
---|---|
LifeBond Ltd. |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of subject's safety by incidence of related Adverse Events | Approx. 1 month | Yes | |
Secondary | Assessment of the device's application technique | Surgeon will complete a questionnaire regarding the device use and ease of application | Intra-operative | No |
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