NCT04944810

Magnetic System in Bariatric and General Surgery

Bariatric, Revisional and General Surgery With Magnetic Assistance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Magnetic devices have been successfully used in bariatric surgery. To the date the only reported use of the magnet was for liver retraction. This study is to demonstrate the safety and viability of using the magnetic system as a second surgical assistant in bariatric surgery and not only for liver retraction.

Detailed description

Patients undergoing primary laparoscopic sleeve gastrectomy (SG), one-anastomosis gastric bypass (OAGB), and Roux-en-Y gastric bypass (RYGB) or revisional surgery by single-port or port-reduced approach. Also others procedures like Nissen/Sleeve gastrectomy or general surgery. The magnetic system can be used like a second assistant in the steps of the surgery for example: liver retraction, upper retraction of gallbladder, retraction of the stomach, upper retraction of jejuno-jejunal anastomosis performing a gastric bypass or closing mesenteric defects liker intermesenteric or Petersen´s defect. Using the single-port device or port-reduced approach to obtain better aesthetic results.

Conditions

• Surgery
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
PROCEDURE	Magnetic Gastric Bypass	Perform a gastric bypass with the magnetic grasper to do the liver retraction, upper retraction of the stomach, upper retraction of the jejuno-jejunal anastomosis, upper retraction of the mesocolon to close petersen defect or the jejuno-jejunal anastomosis to close the intermesenteric defect also to do the retraction of the omega limb and perform the section of the limb and finish the gastric bypass
PROCEDURE	Magnetic Sleeve Gastrectomy	Perform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach
PROCEDURE	Revisional Bariatric Surgery	Perform liver retraction and also steps of the surgery like upper retraction of the stomach, upper retraction of the jejuno-jejunal anastomosis, upper retraction of the mesocolon to close petersen defect or the jejuno-jejunal anastomosis to close the intermesenteric defect also to do the retraction of the omega limb, upper retraction of the stomach
PROCEDURE	Nissen/Sleeve Gastrectomy with Magnetic Assistance	Perform a nissen-sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach, retraction of the stomach to close the hiatal defect and perform a nissen funduplication before do the sleeve gastrectomy
PROCEDURE	Mangetic General Surgery	Use the magnetic grasper to do the gallbladder retraction in cholecystectomies and upper retraction of the stomach to close the defect on hiatal hernia cases.

Timeline

• Start date: 2021-06-10
• Primary completion: 2024-10-10
• Completion: 2026-06-10
• First posted: 2021-06-30
• Last updated: 2022-07-08

Locations

1 site across 1 country: Venezuela