Clinical-stage medical device company, GI Windows, Inc., tells us the Digestive Diseases Week congress has seen the presentation of six-month results of the first-ever clinical study evaluating the endoscopic creation of a dual-path enteral diversion using the company’s Incision-less Anastomosis System (IAS). The data support the safety and efficacy of GI Windows’ IAS as a treatment option for Type 2 diabetes in obese patients.
Obese patients with Type 2 diabetes can experience significant and lasting metabolic improvements through bariatric surgeries, such as the gastric bypass. The GI Windows technology enables a non-surgical procedure that can divert a portion of ingested food from the proximal to distal small bowel, providing a less-invasive approach to achieve comparable long-term metabolic benefits as those seen in bariatric surgery.
The GI Windows dual-path enteral diversion is created with a flexible endoscope, smart magnetic devices being deployed from the scope and self-assembled in the small bowel. The devices transform from a linear shape to an octagonal geometry and then couple to form an anastomosis the devices being eventually expelled naturally, leaving behind an anastomosis without residual foreign material.
The study presented this week reported on the safety and metabolic impact of a dual-path enteral diversion using GI Windows’ Incision-less Anastomosis System. The procedure was performed on 10 obese patients, with a mean body mass index of 41. Four patients had Type 2 diabetes and three more patients were in the pre-diabetic range.
Patients enrolled in the study were restricted to a two-week post-op liquid/soft diet, underwent an upper GI series to confirm anastomotic patency at two weeks post implant, and received follow-up endoscopies at two and six months to visualize the anastomosis.
The study found that the dual-path enteral diversion was safely created in all patients, and the IAS devices were expelled without incident. At six months, investigators observed that all patients experienced significant reductions in HbA1c and fasting blood glucose levels. For patients with pre-diabetes, HbA1c levels were reduced from a mean baseline of 6.1 percent to 5.25 percent at six months, and fasting blood glucose levels decreased from 119 mg/dl to 105 mg/dl. Patients with Type 2 diabetes showed a decrease of HbA1c from a mean baseline of 7.8 percent to 6.0 percent at six months, with a decrease in fasting blood glucose levels from 177 mg/dl to 111mg/dl. All patients had fasting blood glucose levels move from the diabetic or pre-diabetic range to the normal range at six months. The mean weight loss for all patients was approximately 28 pounds (12.9 kg), representing a 10.6 percent decrease in total weight loss.
“Type 2 diabetes is a global pandemic and non-surgical treatment options are needed to effectively help the millions of patients manage this chronic condition,” said Evžen Machytka, MD, PhD, Ostrava University Hospital, a study investigator. “The results from this six-month study are promising and suggest that the IAS, which relies on mechanisms of action proven in surgical approaches, has the potential to markedly reduce HbA1c, fasting blood glucose levels, and weight in obese patients with Type 2 diabetes. These findings warrant further investigation of the IAS technology.”
“Based on this study’s findings, we believe the dual-path enteral diversion, created with the IAS system, may be a viable treatment option for obese patients living with Type 2 diabetes,” said James Wright, President and CEO of GI Windows. “Durability of effect, with non-surgical delivery, is at the core of the GI Windows value proposition. We are pleased with the results we are seeing at 6 months and look forward to presenting 12-month data with the self-assembling magnets in an upcoming publication.”
Source: Business Wire