LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

LifeBond

Status: Completed

Conditions: Rectal Cancer

Treatments: Device: LifeSeal™ Kit

Study type: Interventional

Funder types: Industry

Identifiers

NCT01790230

CLP-LS-0105

Details and patient eligibility

About

A preliminary Study in Subjects Undergoing Low Anterior Resection

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Standard of Care Arm - subjects treated by routine manner

LifeSeal™ Kit

Experimental group

Description:

LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment

Treatment:

Device: LifeSeal™ Kit