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CompletedNCT02046278Updated Aug 30, 2016

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

An interventional study of LifeSeal™ Kit in Rectal Cancer, sponsored by LifeBond Ltd.. Completed at 8 sites in 3 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-30.

Sponsored by LifeBond Ltd. (part of Becton, Dickinson and Company) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Rectal Cancer

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03

In context

Rectal Neoplasms

1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.

This study's enrollment of 70 is close to the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

LifeBond Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • 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

Interventions

  • DeviceLifeSeal™ Kit
06

What researchers measure

Primary outcomes

  1. Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.

    Time frame: Up to 15 weeks

Secondary outcomes

  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

07

Study locations

8 sites
  • OLV Ziekenhuis
    Aalst, Belgium
  • Ziekenhuis Oost-Limburg
    Genk, Belgium
  • University Hospital
    Ghent, Belgium
  • UZ Leuven
    Leuven, Belgium
  • Sourasky Medical Center
    Tel Aviv, Israel
  • Skane University Hospital
    Malmö, Sweden
  • Karolinska Institutet
    Stockholm, Sweden
  • Uppsala University Hospital
    Uppsala, SE-751 85, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02046278
Lead sponsor
LifeBond Ltd.
Responsible party
Sponsor
First posted
Jan 27, 2014
Start date
Jan 2014
Primary completion
Aug 2014
Completion
Aug 2016
Last update
Aug 30, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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