Bariatric Surgery CandidateNCT04931706
Nissen Sleeve by Single Port With Magnetic Assistance
An observational study of Bariatric Surgery Candidate and Obesity, run by Unidad Internacional de Cirugia Bariatrica y Metabolica at 1 site in Venezuela.
Trial summary
New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, GERD
- What is being tested?
- Magnetics Assisted by Singe port
- How many people
- 300 participants
- Where
- 1 siteVenezuela
- Study dates
- 5 Jun 2021to 5 Dec 2023
- How long will I take part?
- 2 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the UICBM from Venezuela-Colombia
Who may be able to join
- Any patient with controlled comorbidities suffering from obesity and GERD.
Who cannot join
- Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases
Trial locations and contacts
1 site in 1 country.
Venezuela1 site, 1 recruiting
- Recruiting
Unidad Internacional de Cirugia Bariatric y Metabolica
Maracaibo, Zulia, 4002
Guillermo Borjas, M.D
About this study
Official title: Double Magnetic-assisted Single-port Nissen Sleeve
New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system
Read the detailed description
A bariatric surgery is performed for weight loss and esophagogastric reflux, called Nissen Sleeve, in which a new approach is used which is the only port that helps to shorten the hospital stay because it decreases postoperative pain as well as increases the esthetic Ad benefit. In addition, a system of magnets is used to assist in different steps of the surgery for the correct retraction of the tissues and to be able to suture or perform the correct dissection.
- Conditions
- Bariatric Surgery Candidate, Obesity, GERD
- Being tested
- Magnetics Assisted by Singe port
- Keywords
- Bariatric Surgery, Magnetic assisted, Singe port, Nissen Sleeve
- Medical subject headings
- Obesity, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetics Assisted by Singe portOther
Use of magnet for assistance through the surgery, and a novel approach as it is single port
| Study group | Role | What they receive |
|---|---|---|
| N-Sleve patients | Patient that were selected for surgery Receives: Other: Magnetics Assisted by Singe port |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Complications
any adverse event during the surgery
Measured: 1 month
Surgical time
how long does the surgery take
Measured: 30 minutes
Weight loss follow up
Kg that the patient loss
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start5 Jun 2021
- Primary completion5 Jun 2023 (estimated)
- Study completion5 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- 300 participants (estimated)
- Target duration
- 2 Years
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, M.D., Principal investigator, UICBM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931706
- Sponsor's protocol ID
- UICBM
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 18 Jun 2021
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Magnetic-assisted Single-port Nissen Sleeve
- ClinicalTrials.gov ID
- NCT04931706
- Acronym / sponsor ID
- UICBM
- Conditions
- Bariatric Surgery Candidate, Obesity, GERD
- Keywords
- Bariatric Surgery, Magnetic assisted, Singe port, Nissen Sleeve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Unidad Internacional de Cirugia Bariatrica y MetabolicaUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 5 Jun 2023 (estimated)
- Study completion
- 5 Dec 2023 (estimated)
- First posted
- 18 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.
New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system
Detailed description
A bariatric surgery is performed for weight loss and esophagogastric reflux, called Nissen Sleeve, in which a new approach is used which is the only port that helps to shorten the hospital stay because it decreases postoperative pain as well as increases the esthetic Ad benefit. In addition, a system of magnets is used to assist in different steps of the surgery for the correct retraction of the tissues and to be able to suture or perform the correct dissection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-Sleve patients | – | Other: Magnetics Assisted by Singe portPatient that were selected for surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the UICBM from Venezuela-Colombia
Key inclusion criteria (1 listed)
- Any patient with controlled comorbidities suffering from obesity and GERD.
Key exclusion criteria (1 listed)
- Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases
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 |
|---|---|---|
| Magnetics Assisted by Singe portUse of magnet for assistance through the surgery, and a novel approach as it is single port | Other | N-Sleve patients |
Primary outcome
Surgical Complications
Time frame: 1 month
any adverse event during the surgery
Surgical time
Time frame: 30 minutes
how long does the surgery take
Weight loss follow up
Time frame: 1 month
Kg that the patient loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- 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, M.D. principal investigator
UICBM
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 Bariatric Surgery Candidate and Obesity, 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 1 inclusion and 1 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 18 Jun 2021. 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, M.D. (4146863041, MaldonadoAndres94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Complications (time frame: 1 month). The study lists 3 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 18 Jun 2021.