The objective of the MagDI Canada study is to evaluate the performance and safety of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion as one example of a small bowel clinical procedure requiring a side-to-side anastomosis. The secondary objective includes initial efficacy of the duodeno-ileal diversion using the MagDI System.
The objective of the MagDI Canada study is to evaluate the performance and safety of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion as one example of a small bowel clinical procedure requiring a side-to-side anastomosis. The secondary objective includes initial efficacy of the duodeno-ileal diversion using the MagDI System. The partial diversion of intestinal contents from the duodenum to the ileum via side-to-side duodeno-ileostomy is intended to facilitate weight management / loss in obese adults and improve metabolic outcomes in obese adults with type 2 diabetes mellitus (T2DM). Side-to-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. The most common side-to-side anastomosis technique used today is stapling, requiring cutting of the intestines and staples remain behind in the body. Linear staplers are available in different sizes (e.g., 30mm, 45mm, 50mm, 60mm). A predicate for this side-to-side duodeno-ileostomy diversion procedure is the single-anastomosis duodeno-ileostomy (SADI) procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Anastomoses achieved by magnetic compression.
University of Toronto
Toronto, Ontario, Canada
NOT_YET_RECRUITINGMcGill University
Montreal, Quebec, Canada
NOT_YET_RECRUITINGWestmount Square Surgical Center
Westmount, Quebec, Canada
RECRUITINGPerformance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.
The duodeno-ileal diversion will be considered feasible if it results in successful: * Placement of the Magnets (≥ 90% alignment of magnets) and * Passage of Magnets without surgical re-intervention; and * Creation of a patent anastomosis confirmed radiologically. The primary endpoint will be met if the performance is confirmed in ≥ 80% of enrolled and treated participants.
Time frame: From date of study index procedure through 90 days
Safety of the MagDI System
Freedom from serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including: * All-cause mortality * Intestinal perforation and/or peritonitis * Intestinal obstruction * Life-threatening bleeding * Incidence of device malfunctions
Time frame: From date of study index procedure through 360 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.