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A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome

NCT04979234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-02-24

No results posted yet for this study

Summary

This study aims to evaluate the efficacy of an endoluminal gastric plication using an endoluminal-suturing device to improve severe OSAS in patients with a BMI above or equal to 28 kg/m² until 34.9kg/m².

Conditions

  • Sleep Apnea Syndromes
  • Overweight and Obesity

Interventions

DEVICE

Endomina- Endoscopic Sleeve Gastroplasty

Endoscopic gastric reduction

BEHAVIORAL

Diet

Multidisciplinary follow up

Sponsors & Collaborators

  • Endo Tools Therapeutics S.A.

    collaborator INDUSTRY

  • Erasme University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2023-01-01
Completion
2023-02-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04979234 on ClinicalTrials.gov