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

This study has been completed.
Sponsor:
Information provided by:
Niti Medical Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT00497263
First received: July 4, 2007
Last updated: June 28, 2011
Last verified: June 2011

July 4, 2007
June 28, 2011
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functioning anastomosis & no occurrence of adverse events related to device use [ Time Frame: during hospitalization and until 3 months after discharge ]
Same as current
Complete list of historical versions of study NCT00497263 on ClinicalTrials.gov Archive Site
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End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study
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the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis

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Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Colorectal Cancer
  • Diverticulitis
Device: Niti CAR
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00497263
CLP-43-01 Rev 01
Yes
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Niti Medical Technologies Ltd.
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Principal Investigator: André D'Hoore, MD, PhD University Hospitals Gasthuisberg Leuven
Niti Medical Technologies Ltd.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP