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OpenTrials
Completed

NCT Number: NCT01790230

LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

A preliminary Study in Subjects Undergoing Low Anterior Resection

Completed

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital

Uppsala, SE-751 85, Sweden

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
  • Subject is at least 18 years of age
  • Subject is scheduled for elective open resection
  • Stapled anastomosis created within 10cm of the anal verge
  • Subject is willing to comply with the follow-up requirements of the study

Exclusion criteria

  • Subject has a history of hypersensitivity to porcine derived gelatin or collagen
  • Subject has unacceptable baseline hematological results
  • Subject on chronic preoperative treatment with steroids and anticoagulants
  • Subject with elevated liver function tests
  • Subject with abnormal kidney function
  • Subject with a BMI higher than 35
  • Subject participating in any other study for either drug or device which can influence collection of valid data under this study
  • Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year
  • Anastomosis was performed differently from what was defined
  • Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™
  • Subject has intraoperative bleeding in excess of 500cc
  • Subject has peritoneal carcinomatosis

Treatment and study plan

LifeSeal™ Kit

Device

Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection

Primary outcomes

  1. Assessment of subject's safety by incidence of related Adverse Events

    Time frame: Approx. 1 month

Secondary outcomes

  1. Assessment of the device's application technique

    Time frame: Intra-operative

    Surgeon will complete a questionnaire regarding the device use and ease of application

Sponsors and collaborators

Lead sponsor

LifeBond Ltd.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2013
Registry last updated
Sep 4, 2013

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.

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