LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

Rectal Cancer Clinical Trial

Official title:

LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790230
• Other study ID #: CLP-LS-0105
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: September 1, 2013
• Start date: January 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: LifeBond Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

A preliminary Study in Subjects Undergoing Low Anterior Resection

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Device:
• LifeSeal™ Kit
Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
LifeBond Ltd.

Country where clinical trial is conducted

Sweden, 

Outcome

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