Rectal Cancer
Conditions
Brief summary
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
Interventions
DEVICELifeSeal™ Kit
Sponsors
LifeBond Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subject, or authorized representative, signed a written Informed Consent Form 2. Subject is 18 years or older 3. Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge. 4. If female - not be of child bearing potential, or be using acceptable contraception methods. 5. Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.
Exclusion criteria
1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen 2. Subject participating in any other study involving an investigational (unapproved) drug or device. 3. Subject with a BMI higher than 40 4. Female Subject states that she is pregnant or breast feeding 5. Subject with ASA status higher than 3 6. Avastin use within 30 days prior to surgery 7. Subject who underwent a prior pelvic anastomosis 8. Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events. | Up to 15 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Performance Rate of anastomotic leak (both radiological and clinical leaks) | Up to 15 weeks post procedure or at stoma closure, whichever comes first |
Countries
Belgium, Israel, Sweden
Outcome results
None listed