Sleep Apnea SyndromesEndoSASNCT04979234
A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome
A study testing Endomina- Endoscopic Sleeve Gastroplasty and Diet in people with Sleep Apnea Syndromes and Overweight and Obesity, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea Syndromes, Overweight and Obesity
- What is being tested?
- Endomina- Endoscopic Sleeve Gastroplasty and Diet
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Sep 2020to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea Syndromes, Overweight and Obesity
- Being tested
- Endomina- Endoscopic Sleeve Gastroplasty, Diet
- Medical subject headings
- Sleep Apnea Syndromes, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endomina- Endoscopic Sleeve GastroplastyDevice
Endoscopic gastric reduction
DietBehavioural
Multidisciplinary follow up
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Endoscopic gastric reduction Receives: Device: Endomina- Endoscopic Sleeve Gastroplasty; Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness on OSAS
Proportion of patients with an apnea-hypopnea index (AHI) reduction of 50% , after the endoscopic procedure.
Measured: 6 months of follow up
Secondary outcomes (6)
Effectiveness on weight loss
Information on efficacy will be obtained by measurements of total weight loss and excess weight loss
Measured: 6 months of follow up
Change of the Epworth sleepiness scale
Reduction of the Epworth sleepiness scale
Measured: 6 months of follow up
Change of respiratory parameters
Increasing of FEV1 (L) (Mandatory expiratory volume in 1 second)
Measured: 6 months of follow up
Change of respiratory parameters
Increasing of TLC (L) (Total lung capacity)
Measured: 6 months of follow up
Change of respiratory parameters
Increasing of KCO (%) (CO diffusion)
Measured: 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
Measured: During procedure and during the 6 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start21 Sep 2020
- Primary completion1 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Endo Tools Therapeutics S.A.
- Responsible party
- Principal investigator, Michael Fernandez Y Viesca, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979234
- Sponsor's protocol ID
- P2020/382
- Acronym
- EndoSAS
- Status last verified
- Feb 2023
- First submitted
- 13 Apr 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome : EndoSAS
- ClinicalTrials.gov ID
- NCT04979234
- Acronym / sponsor ID
- EndoSAS / P2020/382
- Conditions
- Sleep Apnea Syndromes, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Endo Tools Therapeutics S.A.
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Endomina- Endoscopic Sleeve Gastroplasty, Behavioral: DietEndoscopic gastric reduction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endomina- Endoscopic Sleeve GastroplastyEndoscopic gastric reduction | Device | Interventional |
| DietMultidisciplinary follow up | Behavioural | Interventional |
Primary outcome
Effectiveness on OSAS
Time frame: 6 months of follow up
Proportion of patients with an apnea-hypopnea index (AHI) reduction of 50% , after the endoscopic procedure.
6 secondary outcomes
Effectiveness on weight loss
Time frame: 6 months of follow up
Change of the Epworth sleepiness scale
Time frame: 6 months of follow up
Change of respiratory parameters
Time frame: 6 months of follow up
Change of respiratory parameters
Time frame: 6 months of follow up
Change of respiratory parameters
Time frame: 6 months of follow up
Incidence of all adverse event
Time frame: During procedure and during the 6 months of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endomina- Endoscopic Sleeve Gastroplasty and Diet in people with Sleep Apnea Syndromes and Overweight and Obesity, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness on OSAS (time frame: 6 months of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.