Endomina (Endo Tools Therapeutics, Nivelles, Belgium) is CE mark robot driven device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of devices during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing, via a transoral route.
After a first trial on pigs (safety) we did a second trial on human. This trial included 11 patients treated with the same technique. There were no complications and the short term results were encouraging.
Study design:
Prospective, non-randomized, interventional, open-label, multi-center efficacy study.
Objectives:
Study to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. In the literature the efficacy of an endoluminal technique is defined as a loss of weight of 25% excess weight loss (EWL) sustained at 1 year (6).
Endpoints Secondary endpoint: Efficacy Information on efficacy will be obtained by measurements of total weight loss and excess weight loss during 12 months Secondary endpoint: Safety 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.
In addition, safety assessments will be determined based on physical examination (vital signs) and laboratory tests during scheduled visits. Safety evaluations will also be performed to ensure no subsequent adverse events have occurred and to ensure any adverse events during the trial that are considered on-going are stable or have resolved. Safety will be assessed at 1, 3, 6 and 12 months following the intervention.
Sample size •40 patients will be enrolled Based on the result of our previous study, with a beta power of 80% and an alpha error of 5%, the number of patient needed to detect a 25% EWL reduction at one year is 34. Considering a lost to follow-up of 10%, 40 patients is required.
Study duration:
•6 months of enrolment and 12 months of follow up Overall design This will be a prospective, non-randomized, open-label, multi-center, interventional, efficacy study.
A period of approximately 6 months is anticipated form the time the first patient is enrolled to the completion of the last patient. There will be no randomization in this study.
Once baseline eligibility criteria have been met all patients will undergo the same treatment protocol. A subject will be considered "enrolled" if he/she has signed the informed consent, passed all screening criteria and has undergone a procedure.
Criteria for discontinuation If a subject discontinues participation in the study, he or she will be contacted in order to obtain information about the reason(s) for discontinuation and collection of any potential AEs. The Investigator will document the reason for Subject Withdrawal on the Patient Case Report Form (CRF). Discontinued patients will be followed until all AEs resolve or until the Investigator decides that follow-up are no longer necessary.
Study Design:
Devices used during the protocol In addition to Endomina device (provided as companionate by Endotools Options) any other required endoscopic accessories can be used during the procedure.
Point of enrollment A subject will be considered "enrolled" if he/she has signed the informed consent, passed all screening criteria and has agreed to the procedure.
Study duration and number of subjects A period of approximately 6 months is anticipated form the time the time the first patient is enrolled to the completion of the last patient.
Lab tests and other screening procedures can occur as early as 30 days prior to scheduled procedure.
The participants will be followed as follow:
* Day (-1): Admission
* Day (0): Procedure
* Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects observed)
* 1 month: Clinical assessment
* 3 month: Follow up endoscopy, Clinical assessment
* 6 month: Clinical assessment
* 12 month: Clinical and endoscopic assessment On Parallel a nutritional specialist will monitor the patient on quarterly basis (1,3,6,12).
Study procedures 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 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.
