Nissen Sleeve by Single Port With Magnetic Assistance

Sponsor

Unidad Internacional de Cirugia Bariatrica y Metabolica (Other)

Overall Status

Recruiting

CT.gov ID

NCT04931706

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

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
Bariatric Surgery Candidate Obesity GERD	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:

Cohort

Time Perspective:

Prospective

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

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

Surgical Complications [1 month]
any adverse event during the surgery
Surgical time [30 minutes]
how long does the surgery take
Weight loss follow up [1 month]
Kg that the patient loss

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

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

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guillermo Borjas, Director, Unidad Internacional de Cirugia Bariatrica y Metabolica

ClinicalTrials.gov Identifier:

NCT04931706

Other Study ID Numbers:

UICBM

First Posted:

Jun 18, 2021

Last Update Posted:

Jun 18, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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