Endomina Controlled Study
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|ClinicalTrials.gov Identifier: NCT03255005|
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: Endomina Behavioral: Diet||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|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)|
|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|
|Actual Primary Completion Date :||March 26, 2020|
|Actual Study Completion Date :||March 26, 2020|
Active Comparator: Treatment group
Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year
Endoscopic sleeve reduction
Active Comparator: Controled group
Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year
Endoscopic sleeve reduction
- 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.
- Weight loss [ Time Frame: one year from procedure ]total weight loss and excess weight loss
- Weight loss at 6 months [ Time Frame: at 6 months after the procedure (treatment group) ]comparison between diet and treatment group at 6 months
- 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%
- Quality of life [ Time Frame: one year from procedure ]SF36
- TBWL [ Time Frame: one year from procedure ]Mean % total body weight loss (%TBWL)
- Weight and height [ Time Frame: one year from procedure ]To calculate the body mass index (BMI)
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
|Gastroenterology Department Erasme Hospital|
|Brussels, Belgium, 1070|
|APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive|
|Marseille, France, 13915|