LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
1 other identifier
interventional
10
1 country
1
Brief Summary
A preliminary Study in Subjects Undergoing Low Anterior Resection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 31, 2013
CompletedFirst Posted
Study publicly available on registry
February 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedSeptember 4, 2013
September 1, 2013
7 months
January 31, 2013
September 1, 2013
Conditions
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 INTERVENTIONStandard of Care Arm - subjects treated by routine manner
LifeSeal™ Kit
EXPERIMENTALLifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment
Interventions
Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeBond Ltd.lead
Study Sites (1)
Uppsala University Hospital
Uppsala, SE-751 85, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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