The GATE Study: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients Using the Endomina Device

PHASE2UnknownINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 1, 2022

Primary Completion Date

June 1, 2025

Study Completion Date

September 1, 2025

Conditions
Diabete Type 2Obesity
Interventions
DEVICE

Endoscopic sutured gastroplasty with endomina

"The endomina is is used to perform endoscopic sutured gastroplasty. Two guidewires are introduced via an upper GI endoscopy down to the duodenum. The endomina system is introduced and the endoscope is inserted and fixed to the system. Next a needle preloaded with suture is introduced into the platform. The stomach wall is grasped with a forceps and pulled back. The needle is pushed through the wall, and a first tag is released. The needle is retracted, the first plicature is released and a second plicature is made with the same needle at the opposite wall. Then the pretied knot is grasped and tightened until both plicatures are firmly apposed. The same procedure is repeated along the great curvature from the incisura to the upper body.~The procedure will include the placement of 6-9 sutures. The first suture is done at the level of the incisura, at the lower part of the greater curvature. The following stitches are placed along the body of the stomach"

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Endotools Therapeutics

UNKNOWN

lead

Radboud University Medical Center

OTHER