Colorectal Surgery
Conditions
Keywords
Colon Anastomosis, Rectum Anastomosis, Intestine, Colorectal Surgery, Colorectal Anastomosis
Brief summary
Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection. Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon. No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment: During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months. Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.
Interventions
Creation of anastomosis in colorectal surgeries using CAR™ 27
Sponsors
novoGI
HaEmek Medical Center, Israel
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is over 18 years old. 2. Patient is scheduled for a non-emergency procedure. 3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Exclusion criteria
1. Patient has an allergy to nickel. 2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease. 3. Patient is participating in another clinical trial which may affect this study's outcomes. 4. Patient has been taking regular steroid medication. 5. Patient has contraindications to general anesthesia. 6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc. | 3-mo |
Countries
Israel
Outcome results
None listed