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Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Diverticulitis

Thank you

Trial Information

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

Type of Study:


Study Design:

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

Outcome Measure:

functioning anastomosis & no occurrence of adverse events related to device use

Outcome Time Frame:

during hospitalization and until 3 months after discharge

Principal Investigator

André D'Hoore, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals Gasthuisberg Leuven


Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:

CLP-43-01 Rev 01



Start Date:

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Diverticulitis
  • Colorectal Neoplasms
  • Diverticulitis