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

Phase 2

Completed

• Conditions: Colorectal Cancer; Diverticulitis

• Registration Number: NCT00497263
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-04
• Study First Submitted QC: 2007-07-04
• Study First Posted: 2007-07-06
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
functioning anastomosis & no occurrence of adverse events related to device use	during hospitalization and until 3 months after discharge

Trial Locations

Locations (1)

University Hospitals Gasthuisberg Leuven; 🇧🇪 Leuven, Brabant, Belgium