SurgeryNCT04944810
Magnetic System in Bariatric and General Surgery
An observational study of Surgery and Bariatric Surgery Candidate, run by Unidad Internacional de Cirugia Bariatrica y Metabolica at 1 site in Venezuela.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery, Bariatric Surgery Candidate
- What is being tested?
- Magnetic Gastric Bypass, Magnetic Sleeve Gastrectomy and Revisional Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteVenezuela
- Study dates
- 10 Jun 2021to 10 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pantients candidates to bariatric surgery of the international unit of bariatric and metabolic surgery
Who may be able to join
- 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)
Who cannot join
- Patients with pacemakers or electromedical implants
- Uncontrolled metabolic diseases
- Psychiatric problems
Trial locations and contacts
1 site in 1 country.
Venezuela1 site, 1 recruiting
- Recruiting
Unidad Internacional de Cirugía Bariátrica y Metabólica
Maracaibo, Zulia, 4002
Guillermo Borjas, MD. PhD, 4146863041 ext. 58, drguillermoborjas@hotmail.com
EDUARDO Ramos, 4140369840, eduandresrr@gmail.com
About this study
Official title: Bariatric, Revisional and General Surgery With Magnetic Assistance
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.
- Conditions
- Surgery, Bariatric Surgery Candidate
- Being tested
- Magnetic Gastric Bypass, Magnetic Sleeve Gastrectomy, Revisional Bariatric Surgery, Nissen/Sleeve Gastrectomy with Magnetic Assistance, Mangetic General Surgery
- Keywords
- bariatric surgery, gastric bypass, magnetic bariatric surgery, magnetic surgery, magnetic grasper, sleeve gastrectomy, revisional surgery, single-port, reduced-port
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Gastric BypassProcedure or 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 GastrectomyProcedure or surgery
Perform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach
Revisional Bariatric SurgeryProcedure or 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 AssistanceProcedure or 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 SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Magnetic Gastric Bypass; Procedure: Magnetic Sleeve Gastrectomy; Procedure: Revisional Bariatric Surgery; Procedure: Nissen/Sleeve Gastrectomy with Magnetic Assistance; Procedure: Mangetic General Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of surgical complications
Any complications or adverse event during the surgery
Measured: 1-2 hours
Range of surgical time
See if the surgical time is kept normal
Measured: 1-2 hours
Rate of complications related to the magnetic system
Any adverse event or complication related to the magnetic system use during the surgery
Measured: 1-2
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
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start10 Jun 2021
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidad Internacional de Cirugia Bariatrica y Metabolica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Borjas, Unidad Internacional de Cirugia Bariatrica y Metabolica
- Investigators
- Andres Maldonado, MD, Principal investigator, International Unit of Bariatric and Metabolic SurgeryAli Urdaneta, MD. PhD., Principal investigator, International Unit of Bariatric and Metabolic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944810
- Sponsor's protocol ID
- UnidadInterBariatrica
- Status last verified
- Jul 2022
- First submitted
- 10 Jun 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric, Revisional and General Surgery With Magnetic Assistance
- ClinicalTrials.gov ID
- NCT04944810
- Acronym / sponsor ID
- UnidadInterBariatrica
- Conditions
- Surgery, Bariatric Surgery Candidate
- Keywords
- bariatric surgery, gastric bypass, magnetic bariatric surgery, magnetic surgery, magnetic grasper, sleeve gastrectomy, revisional surgery, single-port
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Unidad Internacional de Cirugia Bariatrica y MetabolicaUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic bariatric surgery | – | Procedure: Magnetic Gastric Bypass, Procedure: Magnetic Sleeve Gastrectomy, Procedure: Revisional Bariatric Surgery, Procedure: Nissen/Sleeve Gastrectomy with Magnetic Assistance, Procedure: Mangetic General SurgeryPerform 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pantients candidates to bariatric surgery of the international unit of bariatric and metabolic surgery
Key inclusion criteria (6 listed)
- Patients older than 18 years old
- BMI Greater than 30 kg/m2 (Obesity)
- Candidate to bariatric surgery
- GERD
- Candidate to revisional bariatric surgery
Key exclusion criteria (3 listed)
- Patients with pacemakers or electromedical implants
- Uncontrolled metabolic diseases
- Psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Gastric BypassPerform 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 or surgery | Magnetic bariatric surgery |
| Magnetic Sleeve GastrectomyPerform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach | Procedure or surgery | Magnetic bariatric surgery |
| Revisional Bariatric SurgeryPerform 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 or surgery | Magnetic bariatric surgery |
| Nissen/Sleeve Gastrectomy with Magnetic AssistancePerform 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 or surgery | Magnetic bariatric surgery |
| Mangetic General SurgeryUse the magnetic grasper to do the gallbladder retraction in cholecystectomies and upper retraction of the stomach to close the defect on hiatal hernia cases. | Procedure or surgery | Magnetic bariatric surgery |
Primary outcome
Rate of surgical complications
Time frame: 1-2 hours
Any complications or adverse event during the surgery
Range of surgical time
Time frame: 1-2 hours
See if the surgical time is kept normal
Rate of complications related to the magnetic system
Time frame: 1-2
Any adverse event or complication related to the magnetic system use during the surgery
Outcomes of magnetic grasper acting like a second assistant
Time frame: 1-2 hours
See if the magnetic system it can be used in any step of the surgery like a second surgical assistant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Bariatric Surgery Candidate, run by Unidad Internacional de Cirugia Bariatrica y Metabolica at 1 site in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Borjas, MD. PhD (4146863041, drguillermoborjas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of surgical complications (time frame: 1-2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.