search
Back to results

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

Primary Purpose

Sleep Apnea Syndromes, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Endomina- Endoscopic Sleeve Gastroplasty
Diet
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Erasme

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

Endoscopic gastric reduction

Outcomes

Primary Outcome Measures

Effectiveness on OSAS
Proportion of patients with an apnea-hypopnea index (AHI) reduction of 50% , after the endoscopic procedure.

Secondary Outcome Measures

Effectiveness on weight loss
Information on efficacy will be obtained by measurements of total weight loss and excess weight loss
Change of the Epworth sleepiness scale
Reduction of the Epworth sleepiness scale
Change of respiratory parameters
Increasing of FEV1 (L) (Mandatory expiratory volume in 1 second)
Change of respiratory parameters
Increasing of TLC (L) (Total lung capacity)
Change of respiratory parameters
Increasing of KCO (%) (CO diffusion)
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

Full Information

First Posted
April 13, 2021
Last Updated
February 23, 2023
Sponsor
Erasme University Hospital
Collaborators
Endo Tools Therapeutics S.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT04979234
Brief Title
A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome
Acronym
EndoSAS
Official Title
Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome : EndoSAS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasme University Hospital
Collaborators
Endo Tools Therapeutics S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
Endoscopic gastric reduction
Intervention Type
Device
Intervention Name(s)
Endomina- Endoscopic Sleeve Gastroplasty
Intervention Description
Endoscopic gastric reduction
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
Multidisciplinary follow up
Primary Outcome Measure Information:
Title
Effectiveness on OSAS
Description
Proportion of patients with an apnea-hypopnea index (AHI) reduction of 50% , after the endoscopic procedure.
Time Frame
6 months of follow up
Secondary Outcome Measure Information:
Title
Effectiveness on weight loss
Description
Information on efficacy will be obtained by measurements of total weight loss and excess weight loss
Time Frame
6 months of follow up
Title
Change of the Epworth sleepiness scale
Description
Reduction of the Epworth sleepiness scale
Time Frame
6 months of follow up
Title
Change of respiratory parameters
Description
Increasing of FEV1 (L) (Mandatory expiratory volume in 1 second)
Time Frame
6 months of follow up
Title
Change of respiratory parameters
Description
Increasing of TLC (L) (Total lung capacity)
Time Frame
6 months of follow up
Title
Change of respiratory parameters
Description
Increasing of KCO (%) (CO diffusion)
Time Frame
6 months of follow up
Title
Incidence of all adverse event
Description
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
Time Frame
During procedure and during the 6 months of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs