Gastrointestinal Anastomosis
Conditions
Brief summary
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
Interventions
DEVICECG-100 device
Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site
Sponsors
Colospan Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient is scheduled to undergo an elective colorectal surgery (open or laparoscopic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge * The patient is willing to comply with protocol-specified follow-up evaluations * The patient signed Informed Consent
Exclusion criteria
* Pregnant or nursing female subjects * Patient surgical treatment is acute (not elective) * Patient has infections at the time of intervention * Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study * Patients with ASA (American Society of Anesthesiologists) classification \> 3 * diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease * Patient is participating in another clinical trial within 30 days of screening * Patient has been taking regular steroid medication in the last 6 months * Contraindications to general anesthesia * Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis * Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm * Blood loss (\> 500 cc) * Leak test failure during surgery * Any condition or surgical incidence where the device deployment can jeopardize the patient's safety or interferes with study outcome per the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse events, and device related complications | During surgical procedure and up to 30 days (+/- 5) |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of anastomotic leakage when the CG-100 is used | Up until device removal day (10 days +/-1) |
| Position of the device (internal sheath) | Device removal day (10 days +/-1) |
| Assessment of the device's application technique ease of placement and extraction of the device performance | Device removal day (10 days +/-1) |
| Determine subject tolerability of the device | Device removal day (10 days +/- 1) |
Countries
Belgium, Croatia, Hungary, Israel
Outcome results
None listed