Clinical trial NCT03843801: A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).
Official title: A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Endoscopy
Mini invasive
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Age between 18-64 years;
2. BMI between 30 to 40 kg/m²
3. 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.
4. Must be able to understand and be willing to provide written informed consent.
5. Must have completed the multidisciplinary workup

Exclusion Criteria:

1. Achalasia and any other esophageal motility disorders
2. 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.
3. Hypertension: uncontrolled hypertension during last 3 month
4. Severe renal, hepatic, pulmonary disease or cancer;
5. GI stenosis or obstruction
6. Pregnancy or breastfeeding or willing to become pregnant within study duration
7. History of gastric surgery (any type)
8. Impending gastric surgery 60 days post intervention
9. History of weight changes (±5% TBWL) within the previous 6 months
10. Placement/removal of an intragastric balloon in less than 6 months
11. Currently participating in other study
12. HP positive

Primary outcomes:
measure: Weight loss
timeFrame: one year from procedure
Secondary outcomes:
measure: Gastric emptying
timeFrame: one year from procedure
measure: Satiety test assessed by the correlation between satiety test and the suture pattern related to volume reduction
timeFrame: one year from procedure
measure: sutures
timeFrame: one year from procedure
measure: Excess weight loss
timeFrame: one year from procedure
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: CUB Hopital erasme
city: Brussels
country: Belgium
facility: Gastroenterology Department Erasme Hospital
Study officials:
References: