Colorectal Cancer, Diverticulitis
Conditions
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
Interventions
DEVICENiti CAR
Sponsors
Niti Medical Technologies Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| functioning anastomosis & no occurrence of adverse events related to device use | during hospitalization and until 3 months after discharge |
Countries
Belgium
Outcome results
None listed