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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
History of Changes
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Diverticulitis
 Device: Niti CAR
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Niti Medical Technologies Ltd.:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00497263     History of Changes
Other Study ID Numbers: CLP-43-01 Rev 01
Study First Received: July 4, 2007
Last Updated: June 28, 2011
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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
Gastroenteritis

ClinicalTrials.gov processed this record on May 16, 2013