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

Niti Medical Technologies

Status and phase: Completed; Phase 2

Conditions: Diverticulitis; Colorectal Cancer

Treatments: Device: Niti CAR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00497263

CLP-43-01 Rev 01

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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