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NCT Number: NCT03843801

A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CUB Hopital erasme, Anderlecht, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Endomina

Device

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.

Primary outcomes

  1. Weight loss

    Time frame: one year from procedure

    no difference in weight loss between groups

Secondary outcomes

  1. Gastric emptying

    Time frame: one year from procedure

    Evaluation of the correlation between gastric emptying scintigraphy results and the suture pattern related to motility disruption

  2. Satiety test assessed by the correlation between satiety test and the suture pattern related to volume reduction

    Time frame: one year from procedure

    Evaluation of the correlation between satiety test and the suture pattern related to volume reduction

  3. sutures

    Time frame: one year from procedure

    Evaluation of the correlation between the number of remaining sutures (with gastric remodeling) and weight loss

  4. Excess weight loss

    Time frame: one year from procedure

    Percentage of patients, total and per group, reaching ASGE guidelines of 25% Excess weight loss at 1-year

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Acronym: Pattern

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2019
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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