ClinicalTrials.gg
RecruitingNCT04944810Updated Jul 8, 2022

Magnetic System in Bariatric and General Surgery

An observational study in Surgery and Bariatric Surgery Candidate, sponsored by Unidad Internacional de Cirugia Bariatrica y Metabolica. Recruiting at 1 site in Venezuela. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-08.

Sponsored by Unidad Internacional de Cirugia Bariatrica y Metabolica · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
18 Years to 65 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Surgery
  • Bariatric Surgery Candidate

Keywords

  • bariatric surgery
  • gastric bypass
  • magnetic bariatric surgery
  • magnetic surgery
  • magnetic grasper
  • sleeve gastrectomy
  • revisional surgery
  • single-port
  • reduced-port
03

In context

Lead sponsor

Unidad Internacional de Cirugia Bariatrica y Metabolica is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pantients candidates to bariatric surgery of the international unit of bariatric and metabolic surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with pacemakers or electromedical implants
  • Uncontrolled metabolic diseases
  • Psychiatric problems
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • Magnetic bariatric surgery

    Perform a bariatric surgery using the magnetic device like a second assitant in the steps of the surgery in order to perform the surgery with less incisions and with the same safety

    Procedure: Magnetic Gastric Bypass · Procedure: Magnetic Sleeve Gastrectomy · Procedure: Revisional Bariatric Surgery · Procedure: Nissen/Sleeve Gastrectomy with Magnetic Assistance · Procedure: Mangetic General Surgery

Interventions

  • ProcedureMagnetic 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

  • ProcedureMagnetic Sleeve Gastrectomy

    Perform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach

  • ProcedureRevisional 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

  • ProcedureNissen/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

  • ProcedureMangetic 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.

06

What researchers measure

Primary outcomes

  1. Rate of surgical complications

    Any complications or adverse event during the surgery

    Time frame: 1-2 hours

  2. Range of surgical time

    See if the surgical time is kept normal

    Time frame: 1-2 hours

  3. Rate of complications related to the magnetic system

    Any adverse event or complication related to the magnetic system use during the surgery

    Time frame: 1-2

  4. 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

    Time frame: 1-2 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2021 (actual). Primary completion is estimated for Oct 2024, 40 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2021
First posted
Jun 30, 2021
StartActual
Jun 10, 2021
Primary completionEst.
Oct 10, 2024
CompletionEst.
Jun 10, 2026
Last update
Jul 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04944810
Lead sponsor
Unidad Internacional de Cirugia Bariatrica y Metabolica
Responsible party
Guillermo Borjas (Director of the International Bariatric and Metabolic Surgery Unit, Unidad Internacional de Cirugia Bariatrica y Metabolica) — Principal investigator
First posted
Jun 30, 2021
Start date
Jun 10, 2021
Primary completion
Oct 10, 2024 (estimated)
Completion
Jun 10, 2026 (estimated)
Last update
Jul 8, 2022

Study contacts

Guillermo Borjas, MD. PhD
Contact
drguillermoborjas@hotmail.com
4146863041
Eduardo Ramos, MD
Contact
eduandresrr@gmail.com
4140369840
Andres Maldonado, MD
principal investigator · International Unit of Bariatric and Metabolic Surgery
Ali Urdaneta, MD. PhD.
principal investigator · International Unit of Bariatric and Metabolic Surgery

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion