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OpenTrials
Completed

NCT Number: NCT00497263

End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study

the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals Gasthuisberg Leuven

Leuven, Brabant, 3000, Belgium

Who can participate

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

Inclusion criteria

  • Patient age over 18
  • Patient schedule for colonic surgery requiring E-t-E anastomosis
  • Patient is able to understand and to sign the Informed Consent Form

Exclusion criteria

  • Patient has known allergy to Nickel
  • Patient with bowel obstruction, strangulation, peritonitis, perforation, local or systemic infection
  • Patient on regular steroid medication
  • Patient with preexisting sphincter problems or evidence of extensive local disease of the pelvis
  • Patient following radiation (that compromised the anastomosis)
  • Patient who are undergoing a defunctioning stoma
  • Patient with contraindication to general anesthesia
  • Patient who is currently participating in other clinical trial
  • Patient who refuse consent

Treatment and study plan

Niti CAR

Device

Primary outcomes

  1. functioning anastomosis & no occurrence of adverse events related to device use

    Time frame: during hospitalization and until 3 months after discharge

Sponsors and collaborators

Lead sponsor

Niti Medical Technologies Ltd.

Industry

Registry information

Important dates

First posted
Jul 6, 2007
Registry last updated
Jun 29, 2011

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.

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