Eduardo Espinet-Coll, Román Turró-Arau, Javier Nebreda-Durán, Ramón Abad-Belando, Óscar MartínezNúñez-Martínez, Fernando Saenger, Modesto Varas-Lorenzo, Franco Antonio Samaniego-Aquino, Patricia Díaz-Galán, Antonio Ortega-Sabater, Gerard Grau-Manrubia, Gonzalo López-Roldán, José María Alberdi-Alonso, Manoel Galvao Neto
{"title":"前瞻性，多中心临床试验评估7个月时Stella®胃内球囊和球囊输送系统的安全性","authors":"Eduardo Espinet-Coll, Román Turró-Arau, Javier Nebreda-Durán, Ramón Abad-Belando, Óscar MartínezNúñez-Martínez, Fernando Saenger, Modesto Varas-Lorenzo, Franco Antonio Samaniego-Aquino, Patricia Díaz-Galán, Antonio Ortega-Sabater, Gerard Grau-Manrubia, Gonzalo López-Roldán, José María Alberdi-Alonso, Manoel Galvao Neto","doi":"10.1007/s11695-025-08264-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The intragastric balloon (IGB) is a well-established treatment for obesity. However, several models have been developed to optimize outcomes and procedural efficiency. The Stella®-IGB is a novel, double-lumen device, designed for guidewire-assisted placement to improve procedural safety and patient comfort.</p><p><strong>Methods: </strong>This is a prospective, multicenter, longitudinal, non-randomized study aimed to demonstrate the safety and feasibility of the Stella®-IGB system. Balloon insertion, delivery system, 6-month permanence integrity, 7-month adverse events (AEs) according to Clavien-Dindo AGREE classification, intolerance rate, weight loss and metabolic improvement were investigated.</p><p><strong>Results: </strong>Sixty-nine patients (72.46% females), median age of 42.0 years (IQR 34, 52) and BMI of 33.5 kg/m<sup>2</sup> (IQR 31.0, 36.1) were included. Adequate balloon insertion and 6-month good integrity permanence were obtained in 66/69 (95.65%). Three dysfunction cases were observed: one technical deploy difficulty (twisting of the feeding catheter), one device rupture due to extensive fungal colonization of the balloon and one partially deflated balloon. None presented clinical or endoscopic sequelae. The median balloon insertion time was 4.23 s (IQR 3.04, 5.0), with a first attempt rate of 97.1%. Balloon intolerance was detected in 5.8% of patients. At 6-month follow-up the mean %TWL was 15.39% (95%CI 13.77, 17.00%), with significant metabolic improvement. Globally, 211 grade I-II minor AEs were reported, with no serious AEs (95%CI 0.98, 1).</p><p><strong>Conclusion: </strong>Stella®-IGB uses a double-lumen probe and a guidewire for a more comfortable and safe placement procedure. No serious AEs were observed. Stella®-IGB could expand current indications to IGB placement for endoscopists-in-training and in case of pharyngo-esophageal anatomical alterations.</p><p><strong>Clinical trial number: </strong>NCT06744829.</p>","PeriodicalId":19460,"journal":{"name":"Obesity Surgery","volume":" ","pages":"4440-4451"},"PeriodicalIF":3.1000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12540573/pdf/","citationCount":"0","resultStr":"{\"title\":\"Prospective, Multicenter Clinical Trial to Evaluate the Safety of the Stella® Intragastric Balloon at 7 Months and the Balloon Delivery System.\",\"authors\":\"Eduardo Espinet-Coll, Román Turró-Arau, Javier Nebreda-Durán, Ramón Abad-Belando, Óscar MartínezNúñez-Martínez, Fernando Saenger, Modesto Varas-Lorenzo, Franco Antonio Samaniego-Aquino, Patricia Díaz-Galán, Antonio Ortega-Sabater, Gerard Grau-Manrubia, Gonzalo López-Roldán, José María Alberdi-Alonso, Manoel Galvao Neto\",\"doi\":\"10.1007/s11695-025-08264-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The intragastric balloon (IGB) is a well-established treatment for obesity. However, several models have been developed to optimize outcomes and procedural efficiency. The Stella®-IGB is a novel, double-lumen device, designed for guidewire-assisted placement to improve procedural safety and patient comfort.</p><p><strong>Methods: </strong>This is a prospective, multicenter, longitudinal, non-randomized study aimed to demonstrate the safety and feasibility of the Stella®-IGB system. Balloon insertion, delivery system, 6-month permanence integrity, 7-month adverse events (AEs) according to Clavien-Dindo AGREE classification, intolerance rate, weight loss and metabolic improvement were investigated.</p><p><strong>Results: </strong>Sixty-nine patients (72.46% females), median age of 42.0 years (IQR 34, 52) and BMI of 33.5 kg/m<sup>2</sup> (IQR 31.0, 36.1) were included. Adequate balloon insertion and 6-month good integrity permanence were obtained in 66/69 (95.65%). Three dysfunction cases were observed: one technical deploy difficulty (twisting of the feeding catheter), one device rupture due to extensive fungal colonization of the balloon and one partially deflated balloon. None presented clinical or endoscopic sequelae. The median balloon insertion time was 4.23 s (IQR 3.04, 5.0), with a first attempt rate of 97.1%. Balloon intolerance was detected in 5.8% of patients. At 6-month follow-up the mean %TWL was 15.39% (95%CI 13.77, 17.00%), with significant metabolic improvement. Globally, 211 grade I-II minor AEs were reported, with no serious AEs (95%CI 0.98, 1).</p><p><strong>Conclusion: </strong>Stella®-IGB uses a double-lumen probe and a guidewire for a more comfortable and safe placement procedure. No serious AEs were observed. Stella®-IGB could expand current indications to IGB placement for endoscopists-in-training and in case of pharyngo-esophageal anatomical alterations.</p><p><strong>Clinical trial number: </strong>NCT06744829.</p>\",\"PeriodicalId\":19460,\"journal\":{\"name\":\"Obesity Surgery\",\"volume\":\" \",\"pages\":\"4440-4451\"},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2025-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12540573/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Obesity Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s11695-025-08264-y\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/9/19 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Obesity Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11695-025-08264-y","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/19 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
Prospective, Multicenter Clinical Trial to Evaluate the Safety of the Stella® Intragastric Balloon at 7 Months and the Balloon Delivery System.
Background: The intragastric balloon (IGB) is a well-established treatment for obesity. However, several models have been developed to optimize outcomes and procedural efficiency. The Stella®-IGB is a novel, double-lumen device, designed for guidewire-assisted placement to improve procedural safety and patient comfort.
Methods: This is a prospective, multicenter, longitudinal, non-randomized study aimed to demonstrate the safety and feasibility of the Stella®-IGB system. Balloon insertion, delivery system, 6-month permanence integrity, 7-month adverse events (AEs) according to Clavien-Dindo AGREE classification, intolerance rate, weight loss and metabolic improvement were investigated.
Results: Sixty-nine patients (72.46% females), median age of 42.0 years (IQR 34, 52) and BMI of 33.5 kg/m2 (IQR 31.0, 36.1) were included. Adequate balloon insertion and 6-month good integrity permanence were obtained in 66/69 (95.65%). Three dysfunction cases were observed: one technical deploy difficulty (twisting of the feeding catheter), one device rupture due to extensive fungal colonization of the balloon and one partially deflated balloon. None presented clinical or endoscopic sequelae. The median balloon insertion time was 4.23 s (IQR 3.04, 5.0), with a first attempt rate of 97.1%. Balloon intolerance was detected in 5.8% of patients. At 6-month follow-up the mean %TWL was 15.39% (95%CI 13.77, 17.00%), with significant metabolic improvement. Globally, 211 grade I-II minor AEs were reported, with no serious AEs (95%CI 0.98, 1).
Conclusion: Stella®-IGB uses a double-lumen probe and a guidewire for a more comfortable and safe placement procedure. No serious AEs were observed. Stella®-IGB could expand current indications to IGB placement for endoscopists-in-training and in case of pharyngo-esophageal anatomical alterations.
期刊介绍：
Obesity Surgery is the official journal of the International Federation for the Surgery of Obesity and metabolic disorders (IFSO). A journal for bariatric/metabolic surgeons, Obesity Surgery provides an international, interdisciplinary forum for communicating the latest research, surgical and laparoscopic techniques, for treatment of massive obesity and metabolic disorders. Topics covered include original research, clinical reports, current status, guidelines, historical notes, invited commentaries, letters to the editor, medicolegal issues, meeting abstracts, modern surgery/technical innovations, new concepts, reviews, scholarly presentations and opinions.
Obesity Surgery benefits surgeons performing obesity/metabolic surgery, general surgeons and surgical residents, endoscopists, anesthetists, support staff, nurses, dietitians, psychiatrists, psychologists, plastic surgeons, internists including endocrinologists and diabetologists, nutritional scientists, and those dealing with eating disorders.
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