Nissen Sleeve by Single Port With Magnetic Assistance

NCT ID: NCT04931706

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-05

Study Completion Date

2023-12-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Bariatric Surgery Candidate Obesity GERD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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N-Sleve patients

Patient that were selected for surgery

Magnetics Assisted by Singe port

Intervention Type OTHER

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

Interventions

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Magnetics Assisted by Singe port

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unidad Internacional de Cirugia Bariatrica y Metabolica

OTHER

Sponsor Role lead

Responsible Party

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Guillermo Borjas

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andres Maldonado, M.D.

Role: PRINCIPAL_INVESTIGATOR

UICBM

Locations

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Unidad Internacional de Cirugia Bariatric y Metabolica

Maracaibo, Zulia, Venezuela

Site Status RECRUITING

Countries

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Venezuela

Central Contacts

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Guillermo Borjas, M.D.

Role: CONTACT

4146863041

Facility Contacts

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Guillermo Borjas, M.D

Role: primary

Other Identifiers

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UICBM

Identifier Type: -

Identifier Source: org_study_id

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