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

August 29, 2016 updated by: LifeBond Ltd.
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • OLV Ziekenhuis
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg
      • Gent, Belgium
        • University Hospital
      • Leuven, Belgium
        • UZ Leuven
  • Israel
      • Tel Aviv, Israel
        • Sourasky Medical Center
  • Sweden
      • Malmo, Sweden
        • Skane University Hospital
      • Stockholm, Sweden
        • Karolinska Institutet
      • Uppsala, Sweden, SE-751 85
        • Uppsala university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
Time Frame: Up to 15 weeks
Up to 15 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 15 weeks post procedure or at stoma closure, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeBond Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 24, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-LS-0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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