Clinical Studies
Pilot Clinical Study – Belgium and Italy
The pilot study is the first clinical study of the TOGA® System. As of July 2010 over 180 patients had been treated and two centers in Europe continue to recruit and treat patients. Patients are followed for one year after the procedure. Periodically, patients must report to the study center for endoscopic and other exams, weight measurement and to fill out questionnaires. Patients are expected to participate in post-procedure nutritional / dietary counseling provided by the study center.
The purpose of the study is to evaluate:
- Weight loss
- Safety of the procedure
- Quality of life improvement
- Improvements in obesity-related illnesses
- Changes in medication use
- Technical results
Patients who meet the following criteria may be eligible for entry into the study:
- Age 18 - 60
- BMI ≥ 40 kg/m2 and less than 55 kg/m2, or BMI between 35 and 40 kg/m2 with one or more of the following significant comorbidities:
- Type 2 diabetes mellitus
- Hypertension
- Dyslipidemia (high cholesterol)
- Obstructive sleep apnea
- History of obesity for at least 2.5 years
- History of failure with non-surgical weight loss methods
If you are interested in being screened for eligibility for this study, please contact the applicable study center:
Brussels, Belgium:
Dept. of Gastroenterology and Hepatopancreatology
Hospital Erasme, Universite Libre de Bruxelles
808 Route de Lennik
B 1070 Brussels
Rome, Italy:
(Study open to Italian patients only)
U.O. Endoscopia Digestiva Chirurgica
Istituto di Clinica Chirurgica
Università Cattolica del Sacro Cuore
Policlinico Agostino Gemelli
Largo Agostino Gemelli, 8
00168 Rome Italy
Contact: Carolina Gualtieri - Study Coordinator
+39-06-3015.6580 phone
+39-06-3015.6581 fax
[click to send email]
** The TOGA® System has been granted CE Mark but is not yet available for sale.
