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

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ClinicalTrials.gov Identifier: NCT00497263
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : June 29, 2011
Sponsor:
Information provided by:
Niti Medical Technologies Ltd.

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Diverticulitis Device: Niti CAR Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)



Primary Outcome Measures :
  1. functioning anastomosis & no occurrence of adverse events related to device use [ Time Frame: during hospitalization and until 3 months after discharge ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497263


Locations
Belgium
University Hospitals Gasthuisberg Leuven
Leuven, Brabant, Belgium, 3000
Sponsors and Collaborators
Niti Medical Technologies Ltd.
Investigators
Principal Investigator: André D'Hoore, MD, PhD University Hospitals Gasthuisberg Leuven

ClinicalTrials.gov Identifier: NCT00497263     History of Changes
Other Study ID Numbers: CLP-43-01 Rev 01
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: June 29, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Colorectal Neoplasms
Diverticulitis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intraabdominal Infections
Infection
Gastroenteritis