GI Windows, a West Bridgewater, MA firm, is touting results of the first clinical study of its Incision-less Anastomosis System (IAS). The company’s procedure involves delivering two endoscopes into the small intestine, one toward the beginning and another near the end, and creating an anastomosis between disparate parts of the intestine.
Two magnetic rings are deployed from each end, sticking to each other. The tissue within the circle dies within a week and the ring pops off, eventually making its way out the anus. A good deal of the food is then redirected toward a shorter pass through the small intestine so that fewer nutrients are absorbed.
Some details of the study results according to GI Windows:
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.
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.