Magnetic System in Bariatric and General Surgery

NCT04944810 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2022-07-08

No results posted yet for this study

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.

Conditions

  • Surgery
  • Bariatric Surgery Candidate

Interventions

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.

Sponsors & Collaborators

  • Unidad Internacional de Cirugia Bariatrica y Metabolica

    lead OTHER

Principal Investigators

  • Andres Maldonado, MD · International Unit of Bariatric and Metabolic Surgery

  • Ali Urdaneta, MD. PhD. · International Unit of Bariatric and Metabolic Surgery

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2024-10-10
Completion
2026-06-10

Countries

  • Venezuela

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944810 on ClinicalTrials.gov