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LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046278
Recruitment Status : Completed
First Posted : January 27, 2014
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
LifeBond Ltd.

Study Description
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Brief Summary:
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.

Condition or disease Intervention/treatment Phase
Rectal Cancer Device: LifeSeal™ Kit Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
Study Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2016
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control arm - Standard of Care
The anastomosis will be created using Standard of Care only
Experimental: Device arm - Standard of Care + LifeSeal™ Kit
The anastomosis will be created using SOC + LifeSeal™ Kit
 Device: LifeSeal™ Kit


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events. [ Time Frame: Up to 15 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046278


Locations
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Belgium
OLV Ziekenhuis
Aalst, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
University Hospital
Gent, Belgium
UZ Leuven
Leuven, Belgium
Israel
Sourasky Medical Center
Tel Aviv, Israel
Sweden
Skane University Hospital
Malmo, Sweden
Karolinska Institutet
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
LifeBond Ltd.
More Information
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Responsible Party: LifeBond Ltd.
ClinicalTrials.gov Identifier: NCT02046278    
Other Study ID Numbers: CLP-LS-0110
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases