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MagDI Australia Study
The objective of the MagDI Australia 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).
Study details:
The objective of the MagDI Australia 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 and 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-08-13
Primary completion: 2026-03-01
Study completion finish: 2026-05-30
Study type
TREATMENT
Phase
NA
Trial ID
NCT06473831
Intervention or treatment
DEVICE: Magnet System, DI Biofragmentable
Conditions
- • Type 2 Diabetes
- • Obesity
Find a site
Closest Location:
Dr. Mark Magdy (affiliated with St. George Private Hospital)
Research sites nearby
Select from list below to view details:
Dr. Mark Magdy (affiliated with St. George Private Hospital)
Sydney, New South Wales, Australia
Upper GI Surgery
Sydney, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Magnet System, DI Biofragmentable
| DEVICE: Magnet System, DI Biofragmentable
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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. | 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 | Procedure, Day 90, Day 180, Day 360 |
Secondary outcome
Frequently Asked Questions
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