Prospective, Multicenter Clinical Trial to Evaluate the Safety of the Stella® Intragastric Balloon at 7 Months and the Balloon Delivery System.

IF 3.1 3区医学 Q1 SURGERY

Obesity Surgery Pub Date : 2025-10-01 Epub Date: 2025-09-19 DOI:10.1007/s11695-025-08264-y

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

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引用次数: 0

Abstract

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.

Clinical trial number: NCT06744829.

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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

背景：胃内球囊（IGB）是一种公认的治疗肥胖的方法。然而，已经开发了几个模型来优化结果和程序效率。Stella®-IGB是一种新颖的双流明装置，专为导丝辅助放置而设计，以提高手术安全性和患者舒适度。方法：这是一项前瞻性、多中心、纵向、非随机研究，旨在证明Stella®-IGB系统的安全性和可行性。研究了气囊的插入、输送系统、6个月的永久性完整性、7个月的不良事件（ae）（按Clavien-Dindo AGREE分类）、不耐受率、体重减轻和代谢改善。结果：纳入69例患者，女性占72.46%，中位年龄42.0岁（IQR 34,52）， BMI 33.5 kg/m2 （IQR 31.0, 36.1）。66/69（95.65%）获得了充分的球囊插入和6个月的良好完整性。观察到3例功能障碍：1例技术部署困难（喂食导管扭曲），1例由于球囊广泛的真菌定植而导致装置破裂，1例球囊部分泄气。无临床或内窥镜后遗症。中位球囊插入时间为4.23 s (IQR 3.04, 5.0)，首次尝试率为97.1%。5.8%的患者出现球囊不耐受。随访6个月时，平均TWL为15.39% (95%CI 13.77, 17.00%)，代谢明显改善。在全球范围内，报告了211例I-II级轻微ae，无严重ae （95%CI 0.98, 1）。结论：Stella®-IGB采用双腔探头和导丝，放置过程更加舒适和安全。未见严重不良反应。Stella®-IGB可以将目前的适应症扩展到培训内窥镜医师和咽-食管解剖改变的情况下放置IGB。临床试验号：NCT06744829。

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来源期刊

Obesity Surgery 医学-外科

CiteScore

5.80

自引率

24.10%

发文量

567

审稿时长

3-6 weeks

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.