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Elipse™, a Procedureless Gastric Balloon for Weight Loss: a Proof-of-Concept Pilot Study

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Abstract

Background

Endoscopic gastric balloons have been used effectively as weight loss devices for decades, but the requirement for endoscopy and sedation poses several limitations. The goal of this pilot study was to evaluate the safety and performance of a prototype version of Elipse™, a procedureless gastric balloon.

Methods

Eight patients (mean BMI = 31.0 kg/m2) participated in this study. Each patient swallowed one Elipse™ balloon intended to remain in the stomach for 6 weeks, self-empty, and then pass. Each balloon was filled with 450 mL of filling fluid. Patients returned every 2 weeks for abdominal ultrasound. No specific diet or exercise plan was prescribed.

Results

All eight patients successfully swallowed the device. The most common adverse events were nausea and vomiting. There were no serious adverse events, and all balloons were excreted safely. Despite not being prescribed a diet or exercise plan, all eight patients lost weight. In 6/8 patients, the balloon remained full through 6 weeks, self-emptied, and passed. In one patient, the balloon appeared partially collapsed on ultrasound after 11 days and was endoscopically punctured. One asymptomatic patient elected to have the balloon endoscopically punctured after 19 days. Both balloons passed in the stool after 4 days. In both cases, endoscopic examination of the upper GI tract showed no abnormalities.

Conclusions

This pilot study demonstrates the safety and performance of Elipse™, a procedureless gastric balloon for weight loss. Future studies will test a commercial design filled to 550 mL intended to last in the stomach for at least 12 weeks.

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Conflict of Interest

MB, TK, and MB declare that they have no competing interests. EM received consulting fees from Allurion Technologies. KS is a consultant to Allurion Technologies. RC, SL, and SG are shareholders of Allurion Technologies.

Ethical Standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Authors and Affiliations

  1. Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic

    Evzen Machytka, Martina Bojkova & Tomas Kupka

  2. Faculty of Medicine, University of Ostrava, 17. Listopadu 1790, Ostrava, 70800, Czech Republic

    Evzen Machytka, Martina Bojkova, Tomas Kupka & Marek Buzga

  3. Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

    Ram Chuttani

  4. Allurion Technologies, Wellesley, MA, USA

    Kathryn Stecco, Samuel Levy & Shantanu Gaur

Authors
  1. Evzen Machytka
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  2. Ram Chuttani
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  3. Martina Bojkova
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  4. Tomas Kupka
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  5. Marek Buzga
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  6. Kathryn Stecco
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  7. Samuel Levy
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  8. Shantanu Gaur
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Corresponding author

Correspondence to Evzen Machytka.

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Machytka, E., Chuttani, R., Bojkova, M. et al. Elipse™, a Procedureless Gastric Balloon for Weight Loss: a Proof-of-Concept Pilot Study. OBES SURG 26, 512–516 (2016). https://doi.org/10.1007/s11695-015-1783-7

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  • DOI: https://doi.org/10.1007/s11695-015-1783-7

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