Nissen Sleeve by Single Port With Magnetic Assistance

June 15, 2021 updated by: Guillermo Borjas, Unidad Internacional de Cirugia Bariatrica y Metabolica

Double Magnetic-assisted Single-port Nissen Sleeve

New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Venezuela
    • Zulia
      • Maracaibo, Zulia, Venezuela, 4002
        • Recruiting
        • Unidad Internacional de Cirugia Bariatric y Metabolica
        • Contact:
          • Guillermo Borjas, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the UICBM from Venezuela-Colombia

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
N-Sleve patients
Patient that were selected for surgery
Other: Magnetics Assisted by Singe port
Use of magnet for assistance through the surgery, and a novel approach as it is single port

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Complications
Time Frame: 1 month
any adverse event during the surgery
1 month
Surgical time
Time Frame: 30 minutes
how long does the surgery take
30 minutes
Weight loss follow up
Time Frame: 1 month
Kg that the patient loss
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unidad Internacional de Cirugia Bariatrica y Metabolica

Investigators

  • Principal Investigator: Andres Maldonado, M.D., UICBM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2021

Primary Completion (Anticipated)

June 5, 2023

Study Completion (Anticipated)

December 5, 2023

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UICBM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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