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NCT04931706 Clinical Trial

Nissen Sleeve by Single Port With Magnetic Assistance

Obesity Clinical Trial

Official title:
Double Magnetic-assisted Single-port Nissen Sleeve

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04931706
Other study ID # UICBM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 5, 2021
Est. completion date December 5, 2023

Study information
Verified date June 2021
Source Unidad Internacional de Cirugia Bariatrica y Metabolica
Contact Guillermo Borjas, M.D.
Phone 4146863041
Email MaldonadoAndres94@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 5, 2023
Est. primary completion date June 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Any patient with controlled comorbidities suffering from obesity and GERD. Exclusion Criteria: - Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Magnetics Assisted by Singe port
Use of magnet for assistance through the surgery, and a novel approach as it is single port

Locations
Country Name City State
Venezuela Unidad Internacional de Cirugia Bariatric y Metabolica Maracaibo Zulia

Sponsors (1)
Lead Sponsor Collaborator
Unidad Internacional de Cirugia Bariatrica y Metabolica

Country where clinical trial is conducted

Venezuela, 

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