LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

A preliminary Study in Subjects Undergoing Low Anterior Resection

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Device: LifeSeal™ Kit

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, SE-751 85
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard of Care; Standard of Care Arm - subjects treated by routine manner
EXPERIMENTAL: LifeSeal™ Kit; LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment	Device: LifeSeal™ Kit; Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of subject's safety by incidence of related Adverse Events	Approx. 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the device's application technique	Surgeon will complete a questionnaire regarding the device use and ease of application	Intra-operative

Collaborators and Investigators

• Sponsor: LifeBond Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (ESTIMATE): February 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 4, 2013
• Last Update Submitted That Met QC Criteria: September 1, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CLP-LS-0105