Magnetic System in Bariatric and General Surgery

Surgery Clinical Trial

Official title:

Bariatric, Revisional and General Surgery With Magnetic Assistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04944810
• Other study ID #: UnidadInterBariatrica
• Status: Recruiting
• Start date: June 10, 2021
• Est. completion date: June 10, 2026

Study information

• Verified date: July 2022
• Source: Unidad Internacional de Cirugia Bariatrica y Metabolica
• Contact: Guillermo Borjas, MD. PhD
• Phone: 4146863041
• Email: drguillermoborjas[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: June 10, 2026
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients older than 18 years old
• BMI Greater than 30 kg/m2 (Obesity)
• Candidate to bariatric surgery
• GERD
• Candidate to revisional bariatric surgery
• Cholecystitis or Gallstones (General Surgery)

Exclusion Criteria:

• Patients with pacemakers or electromedical implants
• Uncontrolled metabolic diseases
• Psychiatric problems

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Surgery

Intervention

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
• Magnetic Sleeve Gastrectomy
Perform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach
• 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
• 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
• 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.

Locations

Country	Name	City	State
Venezuela	Unidad Internacional de Cirugía Bariátrica y Metabólica	Maracaibo	Zulia

Sponsors (1)

Lead Sponsor	Collaborator
Unidad Internacional de Cirugia Bariatrica y Metabolica

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of surgical complications	Any complications or adverse event during the surgery	1-2 hours
Primary	Range of surgical time	See if the surgical time is kept normal	1-2 hours
Primary	Rate of complications related to the magnetic system	Any adverse event or complication related to the magnetic system use during the surgery	1-2
Primary	Outcomes of magnetic grasper acting like a second assistant	See if the magnetic system it can be used in any step of the surgery like a second surgical assistant	1-2 hours