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

Study Overview
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Brief Summary
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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.

Detailed Description
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Obesity is one of the most critical public health burdens worldwide. Its prevalence is increasing, as well as its comorbidities. The main comorbidity of obesity on the respiratory system is the obstructive sleep apnea syndrome (OSAS). The prevalence of OSAS in the obese population is around 45%. OSAS increased cardiovascular risk and decreased quality of life. The most alterable risk factor of OSAS is obesity. Therefore, weight loss is the cornerstone of the treatment. There is some evidence of the efficacy of weight loss surgery (lap band, sleeve gastrectomy, biliary pancreatic deviation, duodenal switch, and Roux-and-Y-gastric bypass) to improve OSAS. Current recommendations suggest bariatric surgery management for patients with a BMI > 35kg/m2 and OSAS. However, most studies have limited scientific value (retrospective observational trials), and the follow-up of patients is limited, mainly due to patients' inadequate compliance. Moreover, until now, there is no reliable predictor for the percentage of reduction of AHI caused by weight loss. On the other hand, there is no approved treatment in patients presenting a BMI between 28 kg/m² to 34.9kg/m² and OSAS. Endoscopic endoluminal approaches to address obesity have become an important topic of interest over the past decade. Endomina® (Endo Tools Therapeutics, Gosselies, Belgium) is a novel restrictive endoluminal approach. This new procedure permitted a weight loss of 29 % on average sustained at one year. This technique was not yet evaluated in patients with 28 kg/m2 ≤ BMI ≤ 34.9/m2 to improve OSAS. The current feasibility study aims to evaluate the efficacy of an endoluminal gastric plication using an endoluminal-suturing device to improve severe OSAS in patients with above or equal to 28 kg/m², BMI until 34.9kg/m².

Official Title
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Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome : EndoSAS

Conditions
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Sleep Apnea Syndromes, Overweight and Obesity

Intervention / Treatment
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* Device: Endomina- Endoscopic Sleeve Gastroplasty
* Behavioral: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-65 years BMI between 28 to 34.9 kg/m² AHI ≥ 30 events/hour De novo CPAP user, installed within 2 months prior enrollment Must be able to comply with all study requirements for the duration of the study, as outlined in the protocol. This includes complying with the visit schedule as well as study-specific procedures such as clinical assessment, endoscopy, radiography, as well as laboratory investigations Must be able to understand and be willing to provide written informed consent; Had followed the multidisciplinary bariatric workup (blood analyses, dietician, psychologist and doctor appointments) Exclusion Criteria: Presence of an obesity-hypoventilation syndrome defined as a PaCO2 ≥ 45 mmHg without any other respiratory disease. CPAP treatment failure defined as central sleep apnea occurrence under CPAP treatment or a residual AHI > 5 under optimal CPAP treatment. Incompliance to cPAP treatment defined as an observance to cPAP of at least 4 hours per night in average. Achalasia and any other esophageal motility disorders Current severe esophagitis (grade C and D based on Los Angeles Classification) Current Gastro-duodenal ulcer Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity; Hypertension: uncontrolled hypertension during the last 3 months; Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c > 10%); TBWL >5% over the last 6 months Current severe renal, hepatic, pulmonary disease or cancer; Current gastrointestinal stenosis or obstruction Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months Bariatric surgery, balloon or other endoscopic obesity-related therapy within 6 months of enrollment in this study Anticoagulant therapy Impending gastric surgery 60 days post-intervention Psychiatric disorder refuted after psychological evaluation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Endoscopic gastric reduction | Device: Endomina- Endoscopic Sleeve Gastroplasty<br>* Endoscopic gastric reduction<br>Behavioral: Diet<br>* Multidisciplinary follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness on OSAS | Proportion of patients with an apnea-hypopnea index (AHI) reduction of 50% , after the endoscopic procedure. | 6 months of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness on weight loss | Information on efficacy will be obtained by measurements of total weight loss and excess weight loss | 6 months of follow up | 
| Change of the Epworth sleepiness scale | Reduction of the Epworth sleepiness scale | 6 months of follow up | 
| Change of respiratory parameters | Increasing of FEV1 (L) (Mandatory expiratory volume in 1 second) | 6 months of follow up | 
| Change of respiratory parameters | Increasing of TLC (L) (Total lung capacity) | 6 months of follow up | 
| Change of respiratory parameters | Increasing of KCO (%) (CO diffusion) | 6 months of follow up | 
| Incidence of all adverse event | characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants | During procedure and during the 6 months of follow up |