The first patient has been enrolled in Endo Tools Therapeutics’ (ETT) ESTIME clinical trial. The trial is evaluating ETT’s endomina platform, which enables endoscopists to perform a volume reduction of the stomach using a minimally invasive procedure performed through the patient’s mouth. The aim of this prospective, multi-centre randomised controlled trial is to demonstrate that an endoscopic gastroplasty performed with the endomina triangulation platform and the TAPES suturing unit can help type II diabetes patients enter remission through weight loss or reduce their use of antidiabetic medications.
The trial will also evaluate whether the procedure improves patients’ quality of life. It will comprise 11 trial sites in France and 205 study participants. According to the company, the procedure has the potential to transform the treatment options available to patients with type II diabetes and class I obesity.
The first patient was recruited onto the trial, led by endocrinologist Professor Anne-Laure Borel, at Grenoble University Hospital. Following approval by France’s national health authority (HAS - Haute Autorité de Santé) in June 2022, the procedure will be subsidised by the Assurance Maladie insurance fund at a select group of healthcare establishments in France, as part of its Forfait Innovation special funding programme. This is the first study of its kind to be funded by a Forfait Innovation.
“This clinical trial provides a unique opportunity for patients with type II diabetes and class I obesity to receive new treatments,” said Borel. “It is essential that we evaluate innovative weight-loss treatment solutions, so that we can reduce the effects of type II diabetes, a major comorbidity of obesity. If this trial shows the treatment to be effective, it could be a very interesting option for patients.”
The company claims endomina is the only triangulation technology that can be assembled and disassembled at will inside the stomach for a greater working space and easy introduction of instruments into the esophagus. The triangulation platform enables an endoscopist to position different instruments relative to one another and forceps can be used to grab and pull tissue inside endomina to make a plication.
Extending one’s reach through the endomina platform, an endoscopist will be able to perform suturing similar to a laparoscopic intervention, but through the mouth. The endomina is indicated for patients with obese. Restrictive surgery without a surgical opening is now possible. Using an endoscope and endomina, a trained endoscopist can suture the interior walls of the stomach to create volume reduction.
The solution is comprised of two CE-marked products : (1) endomina triangulation platform and (2) TAPES suturing unit. This combination of products is called the “endomina.” Currently, endoscopists are limited in their surgical possibilities; as traditional endoscopes have the therapeutic channels ‘locked’ in the endoscope axis, leaving the endoscopist single-handed. The endomina provides degrees of freedom comparable to the hands of a surgeon, enabling enhanced manoeuvrability.
To date, over 900 procedures have been performed using Endo Tools Therapeutics’ devices across Europe, the US and the Middle East. The clinical benefits of Endomina on obesity have already been proven in routine clinical practice. These findings support the results from earlier clinical trials, with an expected average excess weight loss of over 45% at 12 months.
“We are delighted that the minister for health has granted early support and special funding for the ESTIME trial, allowing patients to be treated within this study,” said Alexandre Chau, CEO of Endo Tools Therapeutics. “The data from the trial will be critical in gaining reimbursement for this technique, which will add a new treatment option for patients with type II diabetes and obesity.”
In Europe, the devices are approved for use in endoscopic gastroplasty procedures for the treatment of obesity, while in the US they are cleared for tissue apposition.