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Trial record 14 of 27 for:    15479938 [PUBMED-IDS]

Endomina Controlled Study

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ClinicalTrials.gov Identifier: NCT03255005
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

Brief Summary:
The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a delayed treatment control group (diet alone; crossover at 6 months) with a treatment group (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.

Condition or disease Intervention/treatment Phase
Obesity Device: Endomina Behavioral: Diet Not Applicable

Detailed Description:

Surgery is currently the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary pancreatic deviation and duodenal switch) or a combination of both (RYGBP).

This latter technique is the most common and most effective surgical procedure performed worldwide and has been processed to be an effective treatment of morbid obesity and its complications, achieving excess weight loss of 65 to 80 %; 1-2 years after surgery.

Vertical gastric plication is a novel surgical approach for reducing the stomach capacity. Anterior surface plication and greater curvature plication are variations of vertical gastric plication that reduce the gastric capacity through infolding of the anterior surface or greater curvature of the stomach, respectively. These approaches have been tested, with positive results.

A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers the potential for additional benefit to the patient, because the procedures continue to become more and more minimally invasive.

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 and might become part of the armamentarium of obesity management.

Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be attached to an endoscope inside the body and allows remote actuation of the device during a peroral intervention. It offers the possibilities of making transoral full thickness tissue apposition and may allow performing, via a transoral route, large plications with tight serosa to serosa apposition.

After a first trial on pigs (safety), a second trial on human patients was performed. This trial included 11 patients treated with the same technique. There were no complications and the short term results were encouraging with 41% EWL at 6 month.

A multicentric trial NCT02582229 entitled: " A Prospective Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction. " is ongoing and inclusion of patients ended in December 2016 with a total of 51 patients included in 3 European centers. Early results of the trial had showed that dietician follow-up is an important part of the success. During that time implementation of the procedure had been done.

The aim of this trial is to compare a control group (diet alone) with a treatment group (Endomina procedure plus diet).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Group A: treatment J0 + Diet 1 year Group B: Diet 6 months - Treatment - Diet 1 year
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Controlled Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) as an Aid for Endoscopic Gastric Reduction
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Treatment group
Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year
Device: Endomina
Endoscopic sleeve reduction

Active Comparator: Controled group
Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year
Device: Endomina
Endoscopic sleeve reduction

Behavioral: Diet
Multidisciplinary follow-up




Primary Outcome Measures :
  1. Incidence of all Adverse Device Effects [ Time Frame: one year from procedure ]
    Safety will be 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.

  2. Weight loss [ Time Frame: one year from procedure ]
    total weight loss and excess weight loss


Secondary Outcome Measures :
  1. Weight loss at 6 months [ Time Frame: at 6 months after the procedure (treatment group) ]
    comparison between diet and treatment group at 6 months

  2. More than 15% weight loss [ Time Frame: one year from procedure ]
    Proportion of patients in the Endomina Group with a loss of weight of more than 15%

  3. Quality of life [ Time Frame: one year from procedure ]
    SF36

  4. TBWL [ Time Frame: one year from procedure ]
    Mean % total body weight loss (%TBWL)

  5. Weight and height [ Time Frame: one year from procedure ]
    To calculate the body mass index (BMI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18-65 years;
  2. Class I or class II obesity (i.e. 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, as well as laboratory investigations;
  4. Must be able to understand and be willing to provide written informed consent;
  5. Must live within 75 km of the treatment site;
  6. Had followed the bariatric multidisciplinary workup (blood analyses, dietician, psychologist and doctor appointments).

Exclusion Criteria:

  1. Achalasia and any other esophageal motility disorders;
  2. Severe esophagitis;
  3. Gastro-duodenal ulcer;
  4. 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;
  5. Hypertension: uncontrolled hypertension during last 3 months;
  6. Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c > 10%);
  7. TBWL >5% over the last 6 months;
  8. Severe renal, hepatic, pulmonary disease or cancer;
  9. GI stenosis or obstruction;
  10. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
  11. Previous bariatric surgery, balloon or other endoscopic obesity-related therapy;
  12. Anticoagulant therapy;
  13. Impending gastric surgery 60 days post intervention;
  14. Currently participating in other study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255005


Contacts
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Contact: vincent huberty, MD 003225553715 vincent.huberty@erasme.ulb.ac.be
Contact: Mona Hammam, SNu 003225554764 mona.hammam@erasme.ulb.ac.be

Locations
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Belgium
Gastroenterology Department Erasme Hospital Recruiting
Brussels, Belgium, 1070
Contact: Vincent Huberty, MD    +3225553715    vincent.huberty@erasme.ulb.ac.be   
France
APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive Not yet recruiting
Marseille, France, 13915
Contact: Marc Barthet, PhD    00334 91 96 87 37    marc.barthet@ap-hm.fr   
Sponsors and Collaborators
Erasme University Hospital

Publications of Results:

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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03255005     History of Changes
Other Study ID Numbers: P2017/401
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erasme University Hospital:
obesity
endoscopy
endoscopic sleeve gastroplasty
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms