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Magnetic System in Bariatric and General Surgery

ConditionsSurgeryBariatric Surgery Candidate
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUnidad Internacional de Cirugia Bariatrica y Metabolica

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients older than 18 years old

BMI Greater than 30 kg/m2 (Obesity)

Candidate to bariatric surgery

GERD

Disqualifiers

Patients with pacemakers or electromedical implants

Uncontrolled metabolic diseases

Psychiatric problems

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic Gastric Bypass

    Procedure/Surgery

    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

    Procedure/Surgery

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

  • Revisional Bariatric Surgery

    Procedure/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

    Procedure/Surgery

    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

    Procedure/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.

Treatment groups

700 Participants
are divided into 1 treatment group
Group A: Magnetic bariatric surgery5 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unidad Internacional de Cirugia Bariatrica y Metabolica

Lead sponsor

Source ClinicalTrials.gov
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