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Background <p>The intragastric balloon (IGB) is a well-established treatment for obesity. However, several models have been developed to optimize outcomes and procedural efficiency.</p> <p>The Stella®-IGB is a novel, double-lumen device, designed for guidewire-assisted placement to improve procedural safety and patient comfort.</p> Methods <p>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> Results <p>Sixty-nine patients (72.46% females), median age of 42.0&#xa0;years (IQR 34, 52) and BMI of 33.5&#xa0;kg/m<sup>2</sup> (IQR 31.0, 36.1) were included.</p> <p>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.</p> <p>The median balloon insertion time was 4.23&#xa0;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.</p> <p>Globally, 211 grade I–II minor AEs were reported, with no serious AEs (95%CI 0.98, 1).</p> Conclusion <p>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> Clinical Trial Number <p>NCT06744829.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月19日

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  • 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

摘要

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.