Obesity Clinical Trial
Official title:
A Controlled Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) as an Aid for Endoscopic Gastric Reduction
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.
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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