NCT04931706

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 8, 2021

Last Update Submit

June 15, 2021

Conditions

Bariatric Surgery CandidateObesityGERD

Keywords

Bariatric SurgeryMagnetic assistedSinge portNissen Sleeve

Outcome Measures

Primary Outcomes (3)

  • Surgical Complications

    any adverse event during the surgery

    1 month

  • Surgical time

    how long does the surgery take

    30 minutes

  • Weight loss follow up

    Kg that the patient loss

    1 month

Study Arms (1)

N-Sleve patients

Patient that were selected for surgery

Other: Magnetics Assisted by Singe port

Interventions

Magnetics Assisted by Singe portOTHER

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

N-Sleve patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the UICBM from Venezuela-Colombia

You may qualify if:

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

You may not qualify if:

  • Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad Internacional de Cirugia Bariatric y Metabolica

Maracaibo, Zulia, 4002, Venezuela

RECRUITING

MeSH Terms

Conditions

ObesityGastroesophageal Reflux

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Andres Maldonado, M.D.

    UICBM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Borjas, M.D.

CONTACT

4146863041MaldonadoAndres94@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 18, 2021

Study Start

June 5, 2021

Primary Completion

June 5, 2023

Study Completion

December 5, 2023

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

VE(1)