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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - CG-100 (A next generation medical device that enhances patient care and treatment following colorectal surgery)

Teaser

Summary

Anastomotic leakage (AL) is a dreaded complication that occurs following colon resection (in up to 26% of patients) and involves a leak of faecal contents into the abdominal cavity. This results in increased morbidity, mortality and increased length of hospital stay and cost. AL has been associated with a 6-39% mortality rate and a 10-100% risk of permanent stoma. The development of a leak correlates with worse prognosis after a curative resection for colorectal cancer. Because surgeons are unable to reliably predict which anastomosis would fail, most will construct a diverting ileostomy for low colorectal anastomosis to circumvent the devastating complications of anastomotic failure.
Despite extensive investigations on technical considerations of anastomosis construction, anastomotic leaks continue to occur at an unacceptably high rate. Typically to prevent the leak, cancer sufferers will undergo a stoma (also called ostomosis) surgical procedure that usually diverts the small bowel toward the abdominal wall in order to prevent faecal content reaching the ansatamosis area, prevent the clinical outcome of anastomic leakage and allowing healing of the anasatamosis area in the meantime. An ostomy bag is connected to the stoma to collect waste. This procudure is carried out in 70 % of patients following colorectal surgery, neverthless, leakage may still occur in up to 3 % of these patients . The diverting stoma leads to a low quality of life for patients, 17 % of patients have complications and 3 % of patients require reoperation. Approximately 700,000 people in the European Union, from young children to senior citizens, have an ostomy, a surgical procedure that creates an artificial opening in the abdomen to the intestines or urinary system to allow for the elimination of bodily wastes. The use of diverting stoma to prevent AL, results in staggering costs for the patient and healthcare system (51,422 EUR total cost per patient).
We have developed a novel device, termed the CG-100, which acts as an internal bypass for waste, removing the need for an external stoma and the resulting ostomy bag. The CG-100 reduces contact between faecal content and the anastomosis site and prevents these complications. The CG-100 also provides the ability to easily perform leak detection during the post-operative period. Overall the CG-100 device will greatly contribute to the sustainability of the health care system by reducing the need for hospital interventions, greatly lowering the cost sustained by healthcare centres and the time spent on doctor-patient interactions and hospitalisation. Although the purpose of ostomy is to treat and reduce patientsâ€™ pain and discomfort, but in many cases ostomy leads to intensified distress and suffering for patients, and causes severe stress as a result of skin irritation (76%), pouch leakage (62%), offensive odour (59%), reduction in pleasurable activities (54%), and depression/anxiety (53%). CG-100 removes these effects by eliminating the need for an ostomy bag altogether and hence increases the quality of life of patients undergoing colon resection procedure.

Work performed

Between 1st March and 30th June 2017, we undertook a full feasibility study of the innovative solution our company developed â€“ CG-100, and the strategy needed for its successful commercialisation and adoption on the market. During the Phase 1 Feasibility Study, we have completed a full analysis of the technical and business potential of CG-100 medical device. Throughout the project, we have expanded our knowledge of the market for anastomotic leak prevention and the benefits our technology can deliver with a particular focus on the European market. In the meantime we have expanded our network of potential stakeholders, including partners, suppliers, and subcontractors, as well as potential pilot users. The Phase 1 Feasibility Study was instrumental in deriving important product and commercialisation developments needed for the market launch of CG-100. The findings have confirmed the next key design and quality improvements based on the investigation of the end-usersâ€™ opinions and needs. With promising growth projections, relative stage of the deviceâ€™s development, and considering overall results of the Phase 1 project, we have concluded that it will be worthy to proceed with the implementation of development and commercialisation plan.

Final results

The CG-100 has strong advantages over competing solutions with easy installation, strong aligned fixation, and simple recovery. Additionally, as the device is placed internally the patient will not suffer from waste leakage, skin irritations and other side effects, which are seen with the external diverting stoma . Furthermore, the CG-100 allows for radiologic testing of the anastomosis integrity prior to its removal, unlike other solutions. The radiological testing is important because we want to be able to check the integrity of the anastomosis before removal of the device. If the patient has a leak but the device is diverting successfully all the content and by that the patient is a symptomatic, we want to be able to verify that before removing the device. And the surgeon may decide to leave the device in place for a few more days or take the patient at this point to do a stoma. In contrast to other intracolonic devices, the CG-100 is physically extracted, therefore the device is not dependent on material or suture degradation and vitally will avoid the complications arising from surgical removal. In comparison with the high costs associated with the use of a diverting stoma following colorectal surgery, the CG-100 will provide the patient and healthcare institute with savings of 27,843 EUR. The CG-100 has a lower inpatient cost as well as having zero costs for outpatient and removal take down procedures. This is due to the lack of additional surgical intervention and no need for outpatient care following simple non-surgical removal of the device.