LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

NCT01790230 | Completed

• 1 other identifier: CLP-LS-0105
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A preliminary Study in Subjects Undergoing Low Anterior Resection

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of subject's safety by incidence of related Adverse Events

  Approx. 1 month

Secondary Outcomes (1)

• Assessment of the device's application technique

  Intra-operative

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care Arm - subjects treated by routine manner

LifeSeal™ Kit

EXPERIMENTAL

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

Device: LifeSeal™ Kit

Interventions

LifeSeal™ Kit DEVICE

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

LifeSeal™ Kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject, or authorized representative, signed a written Informed Consent
• Subject is at least 18 years of age
• Subject is scheduled for elective open resection
• Stapled anastomosis created within 10cm of the anal verge
• Subject is willing to comply with the follow-up requirements of the study

You may not qualify if:

• Subject has a history of hypersensitivity to porcine derived gelatin or collagen
• Subject has unacceptable baseline hematological results
• Subject on chronic preoperative treatment with steroids and anticoagulants
• Subject with elevated liver function tests
• Subject with abnormal kidney function
• Subject with a BMI higher than 35
• Subject participating in any other study for either drug or device which can influence collection of valid data under this study
• Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year
• Anastomosis was performed differently from what was defined
• Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™
• Subject has intraoperative bleeding in excess of 500cc
• Subject has peritoneal carcinomatosis

Sponsors & Collaborators

• LifeBond Ltd.: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 13, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

SE (1)