Back to resultsLifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
LifeSeal™ Kit
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
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)
Sites / Locations
- OLV Ziekenhuis
- Ziekenhuis Oost-Limburg
- University Hospital
- UZ Leuven
- Sourasky Medical Center
- Skane University Hospital
- Karolinska Institutet
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control arm - Standard of Care
Device arm - Standard of Care + LifeSeal™ Kit
Arm Description
The anastomosis will be created using Standard of Care only
The anastomosis will be created using SOC + LifeSeal™ Kit
Outcomes
Primary Outcome Measures
Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
Secondary Outcome Measures
Performance Rate of anastomotic leak (both radiological and clinical leaks)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02046278
Brief Title
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
Official Title
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeBond Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm - Standard of Care
Arm Type
No Intervention
Arm Description
The anastomosis will be created using Standard of Care only
Arm Title
Device arm - Standard of Care + LifeSeal™ Kit
Arm Type
Experimental
Arm Description
The anastomosis will be created using SOC + LifeSeal™ Kit
Intervention Type
Device
Intervention Name(s)
LifeSeal™ Kit
Primary Outcome Measure Information:
Title
Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
Time Frame
Up to 15 weeks
Secondary Outcome Measure Information:
Title
Performance Rate of anastomotic leak (both radiological and clinical leaks)
Time Frame
Up to 15 weeks post procedure or at stoma closure, whichever comes first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
OLV Ziekenhuis
City
Aalst
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
University Hospital
City
Gent
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Skane University Hospital
City
Malmo
Country
Sweden
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
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