Background and study aims Conventional gastric balloons for weight loss require endoscopy for placement and removal. The Elipse device is swallowed, resides in the stomach for 4 months, and is then expelled. The objectives of this study were to assess the safety of Elipse and to measure its effects on weight loss, metabolic parameters, and quality of life. Methods Each participant swallowed one Elipse device, which was filled with 550 mL of filling fluid through a thin delivery catheter that was then removed. Weight was measured every 2 weeks, and metabolic parameters and quality of life were assessed at baseline and at trial exit. Results 34 patients, with a mean body mass index of 34.8 kg/m2, were enrolled. All 34 patients successfully swallowed the Elipse device. All adverse events were either self-limiting or resolved with medication. All balloons were safely excreted. At 4 months, the mean percent total body weight loss was 10 %. Mean waist circumference was reduced by 8.4 cm. Improvements were also seen in hemoglobin A1c, triglycerides, low density lipoprotein, and blood pressure. At trial exit, quality of life measures had improved across all domains. Conclusion These results demonstrate clinically significant weight loss with the Elipse, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Elipse therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life.ClinicalTrials.gov identifier: NCT 02802007.
- MeSH
- design vybavení MeSH
- dilatace škodlivé účinky přístrojové vybavení metody MeSH
- dospělí MeSH
- hmotnostní úbytek * MeSH
- index tělesné hmotnosti MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- obezita diagnóza patofyziologie psychologie terapie MeSH
- výsledek terapie MeSH
- žaludeční balónek * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- MeSH
- bariatrická chirurgie metody trendy využití MeSH
- biliopankreatická diverze metody využití MeSH
- Evropská unie MeSH
- gastroplastika metody trendy využití MeSH
- kvalita života psychologie MeSH
- morbidní obezita chirurgie komplikace terapie MeSH
- žaludeční bypass metody trendy využití MeSH
- Publikační typ
- směrnice pro lékařskou praxi MeSH
In 2005, for the first time in European history, an extraordinary expert panel named BSCG (Bariatric Scientific Collaborative Group), was appointed through joint effort of the major European scientific societies which are active in the field of obesity management. Societies that constituted this panel were: IFSO - International Federation for the Surgery of Obesity, IFSO-EC - International Federation for the Surgery of Obesity - European Chapter, EASO - European Association for Study of Obesity, ECOG - European Childhood Obesity Group, together with the IOTF (International Obesity Task Force) which was represented during the completion process by its representative. The BSCG was composed not only of the top officers representing the respective scientific societies (four acting presidents, two past presidents, one honorary president, two executive directors), but was balanced with the presence of many other key opinion leaders in the field of obesity. The BSCG composition allowed the coverage of key disciplines in comprehensive obesity management, as well as reflecting European geographical and ethnic diversity. This joint BSCG expert panel convened several meetings which were entirely focused on guidelines creation, during the past 2 years. There was a specific effort to develop clinical guidelines, which will reflect current knowledge, expertise and evidence based data on morbid obesity treatment.
- MeSH
- bariatrická chirurgie normy MeSH
- lidé MeSH
- morbidní obezita chirurgie MeSH
- směrnice pro lékařskou praxi jako téma MeSH
- stupeň závažnosti nemoci MeSH
- týmová péče o pacienty normy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- konsensus - konference MeSH
- Geografické názvy
- Evropa MeSH
- MeSH
- bariatrická chirurgie metody trendy využití MeSH
- biliopankreatická diverze metody využití MeSH
- Evropská unie MeSH
- gastroplastika metody trendy využití MeSH
- kvalita života psychologie MeSH
- morbidní obezita chirurgie komplikace terapie MeSH
- žaludeční bypass metody trendy využití MeSH
- Publikační typ
- směrnice pro lékařskou praxi MeSH
