The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy 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 (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).
The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy 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 (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis). 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 or without 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.
Policlinico San Marco
Bergamo, Italy
Maria Cecilia Hispital
Cotignola, Italy
San Raffaelle Hospital
Milan, Italy
Ospedale Evangelco Betania
Naples, Italy
Feasibility and performance 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 Magnet System (≥ 90% alignment of magnets); and * Creation of a patent anastomosis confirmed radiologically, and * Passage of magnets without any surgical re-interventions. The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects.
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: Procedure, Day 90, Day 180, Day 360
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