ClinicalTrials.gg
Status unknownNCT04931706Updated Jun 18, 2021

Nissen Sleeve by Single Port With Magnetic Assistance

An observational study in Bariatric Surgery Candidate, Obesity and GERD, sponsored by Unidad Internacional de Cirugia Bariatrica y Metabolica. Status unknown at 1 site in Venezuela. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-06-18.

Sponsored by Unidad Internacional de Cirugia Bariatrica y Metabolica · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bariatric Surgery Candidate
  • Obesity
  • GERD

Keywords

  • Bariatric Surgery
  • Magnetic assisted
  • Singe port
  • Nissen Sleeve
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 300 is above the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

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
No
Sampling method
Non-probability sample

Study population

Patients from the UICBM from Venezuela-Colombia

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

  • Any patient with controlled comorbidities suffering from obesity and GERD.

Exclusion criteria

Exclusion Criteria:

  • Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • N-Sleve patients

    Patient that were selected for surgery

    Other: Magnetics Assisted by Singe port

Interventions

  • OtherMagnetics Assisted by Singe port

    Use of magnet for assistance through the surgery, and a novel approach as it is single port

06

What researchers measure

Primary outcomes

  1. Surgical Complications

    any adverse event during the surgery

    Time frame: 1 month

  2. Surgical time

    how long does the surgery take

    Time frame: 30 minutes

  3. Weight loss follow up

    Kg that the patient loss

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Unidad Internacional de Cirugia Bariatric y Metabolica
    Maracaibo, Zulia 4002, Venezuela
    Recruiting
    • Guillermo Borjas, M.D · Contact
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 reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2021 (actual). Primary completion is estimated for Jun 2023, 24 months after the start.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 24 months is below that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

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

Registered
Jun 8, 2021
First posted
Jun 18, 2021
StartActual
Jun 5, 2021
Primary completionEst.
Jun 5, 2023
CompletionEst.
Dec 5, 2023
Last update
Jun 18, 2021
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 Jun 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04931706
Lead sponsor
Unidad Internacional de Cirugia Bariatrica y Metabolica
Responsible party
Guillermo Borjas (Director, Unidad Internacional de Cirugia Bariatrica y Metabolica) — Principal investigator
First posted
Jun 18, 2021
Start date
Jun 5, 2021
Primary completion
Jun 5, 2023 (estimated)
Completion
Dec 5, 2023 (estimated)
Last update
Jun 18, 2021

Study contacts

Guillermo Borjas, M.D.
Contact
MaldonadoAndres94@gmail.com
4146863041
Andres Maldonado, M.D.
principal investigator · UICBM

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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