Skip to main content
OpenTrials
Completed

NCT Number: NCT02046278

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OLV Ziekenhuis, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LifeSeal™ Kit

Device

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

Sponsors and collaborators

Lead sponsor

LifeBond Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Jan 27, 2014
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.