CG-100 Medical Professionals
Surgeons and patients could greatly benefit from an alternative to the diverting stoma. Diverting stoma is the standard of care used to reduce morbidity associated with anastomotic leaks, but it involves a high rate of complications associated with the stoma itself along with patient discomfort, reduced quality of life, increased hospital stay, additional surgery and increased medical costs.
The CG-100 Intraluminal Bypass Device is a silicone tubular sheath that is introduced into the colon through the anus, using a designated delivery system. The sheath is positioned proximal to the anastomosis using three inflatable balloons. The sheath is held in position by an extra-luminal ring which encircles the colon. The diameter of the balloons is slightly larger than that of the ring, preventing the sheath from moving downstream beyond the ring location, while still allowing it to move freely inside the colon, preventing damage to the colon wall. After approximately ten days, when the risk for anastomotic leakage is reduced, the anastomosis integrity is checked radiographically (contrast enema) and the sheath and ring are removed without any surgical intervention.
The CG-100 Intraluminal Bypass Device has been approved for use in the European Union (EU) since 2014, and in Israel since 2017.
The CG-100 Clinical study
The study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing the CG-100 Intraluminal bypass device to diverting ileostomy, the current standard of care treatment for Colorectal surgery with mesorectal excision.
This is a randomized study, so patients who meet study requirements and agree to enter the study are randomized to be treated either with the CG-100 intraluminal bypass device or receive a diverting stoma. Patients will be followed up for up to 39 weeks after surgery.
The clinical study main inclusion and exclusion criteria:
- Patient 22-65 years of age at screening.
- Patient is diagnosed with colorectal cancer.
- Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge.
- Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation.
- Patients with ASA classification > 3
- Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression.
- BMI ≥ 40
- Patient has been taking regular systemic/ steroid medication in the last 6 months.
- Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT).
December 3, 2015
Feasibility of an Intraluminal Bypass Device in Low Colorectal Anastomosis: Preliminary Results in a Porcine Model
June 10, 2017
Intraluminal Bypass Device for The Replacement of Diverting Stoma: Results From First Prospective Clinical Trial in 20 Patients.
May 13, 2019
Protection of colorectal anastomosis with an intraluminal bypass device for patients undergoing an elective anterior resection: a pilot study