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

NCT ID: NCT00497263

Last Updated: 2011-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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

Conditions

Colorectal Cancer; Diverticulitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Niti CAR

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Niti Medical Technologies Ltd.

INDUSTRY

Sponsor Role: lead

Principal Investigators

André D'Hoore, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Gasthuisberg Leuven

Locations

University Hospitals Gasthuisberg Leuven

Leuven, Brabant, Belgium

Countries

Belgium

Other Identifiers

CLP-43-01 Rev 01

Identifier Type: -

Identifier Source: org_study_id