ObesityPatternNCT03843801
A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).
A study testing Endomina in people with Obesity, run by Erasme University Hospital at 2 sites in Belgium.
Trial summary
Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- Endomina
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesBelgium
- Study dates
- 2 Apr 2019to 26 Nov 2020
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-64 years;
- BMI between 30 to 40 kg/m²
- 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, gastric emptying scintigraphy, satiety test, as well as laboratory investigations.
- Must be able to understand and be willing to provide written informed consent.
- Must have completed the multidisciplinary workup
Who cannot join
- Achalasia and any other esophageal motility disorders
- 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 last 3 month
- Severe renal, hepatic, pulmonary disease or cancer;
- GI stenosis or obstruction
- Pregnancy or breastfeeding or willing to become pregnant within study duration
Show all 12Show fewer
- History of gastric surgery (any type)
- Impending gastric surgery 60 days post intervention
- History of weight changes (±5% TBWL) within the previous 6 months
- Placement/removal of an intragastric balloon in less than 6 months
- Currently participating in other study
- HP positive
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
CUB Hopital erasme
Anderlecht, 1070
Gastroenterology Department Erasme Hospital
Brussels, 1070
About this study
Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery (1).
Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is CE mark device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of the device during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing endoscopic therapeutic interventions, via a transoral route.
Read more
A first trial including 11 patients assessed feasibility and safety of the technique (2). There were no complications and the short-term results were encouraging. Then a multicentric efficacy study was conducted, including 51 patients (3). The results where EWL of 31% at one year and TBWL of 9% without complications.
Finally a randomized controlled study was done including 73 patients in a 2/1 randomized fashion with a crossover at 6 months. Treated group was with the endomina device and controlled group was diet only. The follow-up was the same in each group. Primary endpoint was to reach the ASGE guideline "difference between a control group and a treatment group of minimum 15%" (4).
Technique and suture pattern have evolved since the first study. The aim of this prospective evaluation is to compare different suture patterns and their mechanism of action.
- Conditions
- Obesity
- Being tested
- Endomina
- Keywords
- Endoscopy, Mini invasive
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndominaDevice
The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Volume reduction | Active comparator | Intragastric sutures are done to reduce the volume of the stomach Receives: Device: Endomina |
| Gastric emptying reduction | Active comparator | Intragastric sutures are done to slower the gastric emptying Receives: Device: Endomina |
| Increasing distension | Active comparator | Intragastric sutures are done to maximalize the gastric distension Receives: Device: Endomina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
no difference in weight loss between groups
Measured: one year from procedure
Secondary outcomes (4)
Gastric emptying
Evaluation of the correlation between gastric emptying scintigraphy results and the suture pattern related to motility disruption
Measured: one year from procedure
Satiety test assessed by the correlation between satiety test and the suture pattern related to volume reduction
Evaluation of the correlation between satiety test and the suture pattern related to volume reduction
Measured: one year from procedure
sutures
Evaluation of the correlation between the number of remaining sutures (with gastric remodeling) and weight loss
Measured: one year from procedure
Excess weight loss
Percentage of patients, total and per group, reaching ASGE guidelines of 25% Excess weight loss at 1-year
Measured: one year from procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start2 Apr 2019
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843801
- Sponsor's protocol ID
- CCB : / B406201838475
- Acronym
- Pattern
- Status last verified
- Mar 2021
- First submitted
- 14 Feb 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).
- ClinicalTrials.gov ID
- NCT03843801
- Acronym / sponsor ID
- Pattern / CCB : / B406201838475
- Conditions
- Obesity
- Keywords
- Endoscopy, Mini invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 18 Feb 2019 (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.
Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery (1).
Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is CE mark device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of the device during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing endoscopic therapeutic interventions, via a transoral route.
A first trial including 11 patients assessed feasibility and safety of the technique (2). There were no complications and the short-term results were encouraging. Then a multicentric efficacy study was conducted, including 51 patients (3). The results where EWL of 31% at one year and TBWL of 9% without complications.
Finally a randomized controlled study was done including 73 patients in a 2/1 randomized fashion with a crossover at 6 months. Treated group was with the endomina device and controlled group was diet only. The follow-up was the same in each group. Primary endpoint was to reach the ASGE guideline "difference between a control group and a treatment group of minimum 15%" (4).
Technique and suture pattern have evolved since the first study. The aim of this prospective evaluation is to compare different suture patterns and their mechanism of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Volume reduction | Active comparator | Device: EndominaIntragastric sutures are done to reduce the volume of the stomach |
| Gastric emptying reduction | Active comparator | Device: EndominaIntragastric sutures are done to slower the gastric emptying |
| Increasing distension | Active comparator | Device: EndominaIntragastric sutures are done to maximalize the gastric distension |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18-64 years;
- BMI between 30 to 40 kg/m²
- 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, gastric emptying scintigraphy, satiety test, as well as laboratory investigations.
- Must be able to understand and be willing to provide written informed consent.
- Must have completed the multidisciplinary workup
Key exclusion criteria (12 listed)
- Achalasia and any other esophageal motility disorders
- 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 last 3 month
- Severe renal, hepatic, pulmonary disease or cancer;
- GI stenosis or obstruction
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 |
|---|---|---|
| EndominaThe intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure. | Device | Gastric emptying reduction, Increasing distension, Volume reduction |
Primary outcome
Weight loss
Time frame: one year from procedure
no difference in weight loss between groups
4 secondary outcomes
Gastric emptying
Time frame: one year from procedure
Satiety test assessed by the correlation between satiety test and the suture pattern related to volume reduction
Time frame: one year from procedure
sutures
Time frame: one year from procedure
Excess weight loss
Time frame: one year from procedure
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 2 Mar 2021.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endomina in people with Obesity, run by Erasme University Hospital at 2 sites 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 5 inclusion and 12 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 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Weight loss (time frame: one year from procedure). 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 2 Mar 2021.