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Endoscopy 2017; 49(02): 154-160
DOI: 10.1055/s-0042-119296
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study

Evzen Machytka
1   Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic
,
Shantanu Gaur
2   Allurion Technologies, Wellesley, Massachusetts, USA
,
Ram Chuttani
3   Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
,
Martina Bojkova
4   Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic
,
Tomas Kupka
4   Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic
,
Marek Buzga
5   Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic
,
Andreas Giannakou
6   Department of Surgery, Iatriko Medical Center, Palaio Faliro, Greece
,
Kandiliotis Ioannis
7   Department of Radiology, Iatriko Medical Center, Palaio Faliro, Greece
,
Elisabeth Mathus-Vliegen
8   Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands
,
Samuel Levy
2   Allurion Technologies, Wellesley, Massachusetts, USA
,
Ioannis Raftopoulos
6   Department of Surgery, Iatriko Medical Center, Palaio Faliro, Greece
9   Comprehensive Weight Loss Institute, Holyoke Medical Center, Holyoke, MA, USA
› Author Affiliations
Further Information

Publication History

submitted09 April 2016

accepted after revision08 September 2016

Publication Date:
12 December 2016 (online)

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Abstract

Background and study aims Conventional gastric balloons for weight loss require endoscopy for placement and removal. The Elipse device is swallowed, resides in the stomach for 4 months, and is then expelled. The objectives of this study were to assess the safety of Elipse and to measure its effects on weight loss, metabolic parameters, and quality of life.

Methods Each participant swallowed one Elipse device, which was filled with 550 mL of filling fluid through a thin delivery catheter that was then removed. Weight was measured every 2 weeks, and metabolic parameters and quality of life were assessed at baseline and at trial exit.

Results 34 patients, with a mean body mass index of 34.8 kg/m2, were enrolled. All 34 patients successfully swallowed the Elipse device. All adverse events were either self-limiting or resolved with medication. All balloons were safely excreted. At 4 months, the mean percent total body weight loss was 10 %. Mean waist circumference was reduced by 8.4 cm. Improvements were also seen in hemoglobin A1c, triglycerides, low density lipoprotein, and blood pressure. At trial exit, quality of life measures had improved across all domains.

Conclusion These results demonstrate clinically significant weight loss with the Elipse, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Elipse therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life.

ClinicalTrials.gov identifier: NCT 02802007.

 

  • References

  • 1 Ng M, Fleming T, Robinson M. et al. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980 – 2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 2014; 384: 766-781
    CrossrefPubMedGoogle Scholar
  • 2 Stanford FC, Kyle TK, Claridy MD. et al. The influence of an individual’s weight perception on the acceptance of bariatric surgery. Obesity (Silver Spring) 2015; 23: 277-281
    CrossrefPubMedGoogle Scholar
  • 3 Genco A, Bruni T, Doldi SB. et al. BioEnterics Intragastric Balloon: the italian experience with 2,515 patients. Obes Surg 2005; 15: 1161-1164
    CrossrefPubMedGoogle Scholar
  • 4 Fuller NR, Pearson S, Lau NS. et al. An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study. Obesity 2013; 21: 1561-1570
    CrossrefPubMedGoogle Scholar
  • 5 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 (Lond) 2006; 30: 129-133
    CrossrefPubMedGoogle Scholar
  • 6 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: 874-881
    CrossrefPubMedGoogle Scholar
  • 7 Abu Dayyeh BK, Kumar N, Edmundowicz SA. et al. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc 2015; 82: 425-438.e425
    CrossrefPubMedGoogle Scholar
  • 8 Imaz I, Martinez-Cervell C, Garcia-Alvarez EE. et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg 2008; 18: 841-846
    CrossrefPubMedGoogle Scholar
  • 9 Dumonceau JM. Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg 2008; 18: 1611-1617
    CrossrefPubMedGoogle Scholar
  • 10 Yap Kannan R, Nutt MR. Are intra-gastric adjustable balloon system safe? A case series. Int J Surg Case Rep 2013; 4: 936-938
    CrossrefPubMedGoogle Scholar
  • 11 Di Saverio S, Bianchini Massoni C, Boschi S. et al. Complete small-bowel obstruction from a migrated intra-gastric balloon: emergency laparoscopy for retrieval via enterotomy and intra-corporeal repair. Obes Surg 2014; 24: 1830-1832
    CrossrefPubMedGoogle Scholar
  • 12 Matar ZS, Mohamed AA, Abukhater M. et al. Small bowel obstruction due to air-filled intragastric balloon. Obes Surg 2009; 19: 1727-1730
    CrossrefPubMedGoogle Scholar
  • 13 Ozturk A, Yavuz Y, Atalay T. A case of duodenal obstruction and pancreatitis due to intragastric balloon. Balkan Med J 2015; 32: 323-326
    CrossrefPubMedGoogle Scholar
  • 14 El Kareh I, Genser L, Siksik JM. et al. Small-bowel obstruction secondary to migration of an intragastric balloon. J Gastrointest Surg 2016; 20: 1409-1410
    CrossrefPubMedGoogle Scholar
  • 15 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: 512-516
    CrossrefPubMedGoogle Scholar
  • 16 Crosby RD, Kolotkin RL, Williams GR. An integrated method to determine meaningful changes in health-related quality of life. J Clin Epidemiol 2004; 57: 1153-1160
    Google Scholar
  • 17 Angenete E, Jacobsson A, Gellerstedt M. et al. Effect of laparoscopy on the risk of small-bowel obstruction: a population-based register study. Arch Surg 2012; 147: 359-365
    CrossrefPubMedGoogle Scholar
  • 18 Barmparas G, Branco BC, Schnuriger B. et al. The incidence and risk factors of post-laparotomy adhesive small bowel obstruction. J Gastrointest Surg 2010; 14: 1619-1628
    CrossrefPubMedGoogle Scholar
  • 19 Khalaf NI, Rawat A, Buehler G. Intragastric balloon in the emergency department: an unusual cause of gastric outlet obstruction. J Emerg Med 2014; 46: e113-116
    CrossrefPubMedGoogle Scholar
  • 20 Roman S, Napoleon B, Mion F. et al. Intragastric balloon for “non-morbid” obesity: A retrospective evaluation of tolerance and efficacy. Obes Surg 2004; 14: 539-544
    CrossrefPubMedGoogle Scholar
  • 21 Gan TJ, Apfel CC, Kovac A. et al. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg 2007; 104: 1082-1089 tables of contents
    CrossrefPubMedGoogle Scholar
  • 22 Sinha AC, Singh PM, Williams NW. et al. Aprepitant’s prophylactic efficacy in decreasing postoperative nausea and vomiting in morbidly obese patients undergoing bariatric surgery. Obes Surg 2014; 24: 225-231
    CrossrefPubMedGoogle Scholar
  • 23 Vallejo MC, Phelps AL, Ibinson JW. et al. Aprepitant plus ondansetron compared with ondansetron alone in reducing postoperative nausea and vomiting in ambulatory patients undergoing plastic surgery. Plast Reconstr Surg 2012; 129: 519-526
    CrossrefPubMedGoogle Scholar
  • 24 Brooks J, Tsvang E, Ganon M. et al. Mo1952 A highly effective anti-vomiting regimen post intragastric balloon implantation. Gastroenterology 2016; 150: S826
    PubMedGoogle Scholar
  • 25 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: 1330-1336
    CrossrefPubMedGoogle Scholar
  • 26 Crea N, Pata G, Della Casa D. et al. Improvement of metabolic syndrome following intragastric balloon: 1 year follow-up analysis. Obes Surg 2009; 19: 1084-1088
    CrossrefPubMedGoogle Scholar