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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Overweight and Obesity
• Intervention / Treatment: Device: Endomina- Endoscopic Sleeve Gastroplasty; Behavioral: Diet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pauline Van Ouytsel; Phone Number: +32 2 555 65 31; Email: pauline.vanouytsel@erasme.ulb.ac.be
• Study Contact Backup: Name: Mia Persoons; Phone Number: +32 2 555 30 16; Email: mia.persoons@erasme.ulb.ac.be

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Hôpital Erasme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Endoscopic gastric reduction	Device: Endomina- Endoscopic Sleeve Gastroplasty; Endoscopic gastric reduction; Behavioral: Diet; Multidisciplinary follow up

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: Endo Tools Therapeutics S.A.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea; Overweight
• Other Study ID Numbers: P2020/382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No