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

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497263
• Other study ID #: CLP-43-01 Rev 01
• Status: Completed
• Phase: Phase 2
• First received: July 4, 2007
• Last updated: June 28, 2011

Study information

• Verified date: June 2011
• Source: Niti Medical Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Diverticulitis

Intervention

Device:
• Niti CAR

Locations

Country	Name	City	State
Belgium	University Hospitals Gasthuisberg Leuven	Leuven	Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Niti Medical Technologies Ltd.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functioning anastomosis & no occurrence of adverse events related to device use		during hospitalization and until 3 months after discharge