LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
Not Applicable
Completed
- Conditions
- Rectal Cancer
- Interventions
- Device: LifeSeal™ Kit
- Registration Number
- NCT02046278
- Lead Sponsor
- LifeBond Ltd.
- Brief Summary
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Subject, or authorized representative, signed a written Informed Consent Form
- Subject is 18 years or older
- Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
- If female - not be of child bearing potential, or be using acceptable contraception methods.
- 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
- Subject has a history of hypersensitivity to porcine derived gelatin or collagen
- Subject participating in any other study involving an investigational (unapproved) drug or device.
- Subject with a BMI higher than 40
- Female Subject states that she is pregnant or breast feeding
- Subject with ASA status higher than 3
- Avastin use within 30 days prior to surgery
- Subject who underwent a prior pelvic anastomosis
- Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device arm - Standard of Care + LifeSeal™ Kit LifeSeal™ Kit The anastomosis will be created using SOC + LifeSeal™ Kit
- Primary Outcome Measures
Name Time Method Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events. Up to 15 weeks
- Secondary Outcome Measures
Name Time Method Performance Rate of anastomotic leak (both radiological and clinical leaks) Up to 15 weeks post procedure or at stoma closure, whichever comes first
Trial Locations
- Locations (8)
OLV Ziekenhuis
🇧🇪Aalst, Belgium
Skane University Hospital
🇸🇪Malmo, Sweden
UZ Leuven
🇧🇪Leuven, Belgium
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Karolinska Institutet
🇸🇪Stockholm, Sweden
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
University Hospital
🇧🇪Gent, Belgium
Sourasky Medical Center
🇮🇱Tel Aviv, Israel