Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473831
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
MagDI Australia Study
Sponsor:
GT Metabolic Solutions Inc
Organization:
GT Metabolic Solutions Inc
Study Overview
Official Title:
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System DI Biofragmentable MagDI System in Australia to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and With Type 2 Diabetes Mellitus MagDI Australia Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg one example of a small bowel clinical procedure requiring a side-to-side anastomosis
Detailed Description:
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 eg 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 eg 30mm 45mm 50mm 60mm A predicate for this side-to-side duodeno-ileostomy diversion procedure is the single-anastomosis duodeno-ileostomy SADI procedure
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 eg 30mm 45mm 50mm 60mm A predicate for this side-to-side duodeno-ileostomy diversion procedure is the single-anastomosis duodeno-ileostomy SADI procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None