Nissen Sleeve by Single Port With Magnetic Assistance

Unidad Internacional de Cirugia Bariatrica y Metabolica (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Magnetics Assisted by Singe port

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Time Perspective:
Official Title:
Double Magnetic-assisted Single-port Nissen Sleeve
Actual Study Start Date :
Jun 5, 2021
Anticipated Primary Completion Date :
Jun 5, 2023
Anticipated Study Completion Date :
Dec 5, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Surgical Complications [1 month]

    any adverse event during the surgery

  2. Surgical time [30 minutes]

    how long does the surgery take

  3. Weight loss follow up [1 month]

    Kg that the patient loss

Eligibility Criteria


Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Any patient with controlled comorbidities suffering from obesity and GERD.
Exclusion Criteria:
  • Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases

Contacts and Locations


Site City State Country Postal Code
1 Unidad Internacional de Cirugia Bariatric y Metabolica Maracaibo Zulia Venezuela 4002

Sponsors and Collaborators

  • Unidad Internacional de Cirugia Bariatrica y Metabolica


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Guillermo Borjas, Director, Unidad Internacional de Cirugia Bariatrica y Metabolica Identifier:
Other Study ID Numbers:
First Posted:
Jun 18, 2021
Last Update Posted:
Jun 18, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Guillermo Borjas, Director, Unidad Internacional de Cirugia Bariatrica y Metabolica

Study Results

No Results Posted as of Jun 18, 2021