LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Device: LifeSeal™ Kit

• Registration Number: NCT01790230
• Lead Sponsor: LifeBond Ltd.

Brief Summary

A preliminary Study in Subjects Undergoing Low Anterior Resection

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-01
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assessment of subject's safety by incidence of related Adverse Events	Approx. 1 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden