Skip to main content

Advertisement

SpringerLink
Log in

Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience

  • Original Contributions
  • Published:
Obesity Surgery Aims and scope Submit manuscript

Abstract

Purpose

The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse™ Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy.

Materials and Methods

The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m2). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy.

Results

There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m2. Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed.

Conclusions

The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Genco A, Bruni T, Doldi SB, et al. BioEnterics intragastric balloon: the Italian experience with 2,515 patients. Obes Surg. 2005;15(8):1161–4.

  2. Imaz I, Martínez-Cervell C, García-Alvarez EE, et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008;18(7):841–6.

  3. Genco A, Cipriano M, Bacci V, et al. BioEnterics intragastric balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes. 2006;30(1):129–33.

  4. Martins Fernandes FA Jr, Carvalho GL, Lima DL, et al. Intragastric balloon for overweight patients. JSLS. 2016;20(1). https://doi.org/10.4293/JSLS.2015.00107

  5. Sullivan S, Edmundowicz SA, Thompson CC. Endoscopic bariatric and metabolic therapies: New and emerging technologies. Gastroenterology. 2017;152(7):1791–801.

    Article  PubMed  Google Scholar 

  6. Messina T, Genco A, Favaro R, et al. Intragastric balloon positioning and removal: sedation or general anesthesia? Surg Endosc. 2011;25(12):3811–4.

  7. Machytka E, Chuttani R, Bojkova M, et al. Elipse, a procedureless gastric balloon for weight loss: a proof-of-concept pilot study. Obes Surg. 2016;26(3):512–6.

  8. Machytka E, Gaur S, Chuttani R, et al. Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study. Endoscopy 2017;49(2):154–60.

  9. Dumonceau JM. Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg. 2008;18(12):1611–7.

    Article  PubMed  Google Scholar 

  10. Fanelli RD, Andrew BD. Is endoluminal bariatric therapy a new paradigm of treatment for obesity? Clin Gastroenterol Hepatol : Off Clin Pract J Am Gastroenterol Assoc. 2016;14(4):507–15.

    Article  Google Scholar 

  11. Ponce J, Woodman G, Swain J, et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11(4):874–81.

  12. Gaur S, Levy S, Mathus-Vliegen L, et al. Balancing risk and reward: a critical review of the intragastric balloon for weight loss. Gastrointest Endosc. 2015;81(6):1330–6.

Download references

Author information

Authors and Affiliations

  1. Department of Surgical Sciences, Surgical Endoscopy Unit, Sapienza University of Rome, Rome, Italy

    A. Genco, G. Casella, E. Soricelli & M. Monti

  2. Department of Experimental Medicine-Medical Physiopathology, Food Science and Endocrinology Section, Sapienza University of Rome, Rome, Italy

    I. Ernesti, R. Ienca, S. Mariani & D. Francomano

  3. National Health Service, Naples, Italy

    M. Lorenzo

Authors
  1. A. Genco
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. I. Ernesti
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. R. Ienca
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. G. Casella
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. S. Mariani
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. D. Francomano
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. E. Soricelli
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. M. Lorenzo
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. M. Monti
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to A. Genco.

Ethics declarations

Conflict of Interest

The authors declare that they have no conflicts of interest.

Ethical Approval

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.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Genco, A., Ernesti, I., Ienca, R. et al. Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience. OBES SURG 28, 405–409 (2018). https://doi.org/10.1007/s11695-017-2877-1

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11695-017-2877-1

Keywords

Search

Navigation