Skip to main content
Top
Published in: Obesity Surgery 3/2021

01-03-2021 | Endoscopy | Original Contributions

Outcomes of a Swallowable Intragastric Balloon (Elipse™) on 96 Overweight and Obese Patients

Authors: Osama Taha, Mahmoud Abdelaal, Awny Asklany, Mohamed Alaa, Sherif Belal, Islam El.Assal, Maha Shahin, Ahmed Abubasha, Dalia Elbanhawy

Published in: Obesity Surgery | Issue 3/2021

Login to get access

Abstract

Background

The traditional gastric balloons have been used for several years to reduce weight in overweight and obese patients, but the need for sedation and upper endoscopy leading to several limitations. The current series is the first study that evaluates the safety and effectiveness of the swallowable gastric (Elipse™) balloon in our population on the national level.

Methods

Ninety-six patients (mean BMI was 33.6 ± 4.3 kg/m2) participated in this study. All patients swallowed one Elipse balloon intended to remain in the stomach for 4 months, self-empty, and then pass. Each balloon was filled with 550 mL of filling fluid. Anti-emetics and anti-spasmodic drugs were prescribed for 2–3 days after insertion; proton pump inhibitor was prescribed twice daily 1 week before the procedure and continued until the end of residence time (16–20 weeks).

Results

In the current series, at end of the procedure (after 4 months), the overall mean weight loss (WL) was 11.2 ± 5.1 kg, mean waist circumference reduction was 10.9 ± 2.1 cm, and a mean BMI reduction was 4.9 ± 2.0 kg/m2. The percentage of total body weight loss (TBWL%) was 12.1 ± 5.2%. The Elipse therapy reported improvements in the metabolic parameters investigated.

Conclusion

This swallowable gastric balloon (Elipse) can be safely and successfully swallowed, filled, imaged, and passed with accepted weight loss and clinical improvement in factors related to the metabolic syndrome.
Literature
1.
go back to reference Guedes EP, Madeira E, Mafort TT, et al. Impact of 6 months of treatment with intragastric balloon on body fat and quality of life in obese individuals with metabolic syndrome. Health Qual Life Outcomes. 2017;15(1):211.CrossRef Guedes EP, Madeira E, Mafort TT, et al. Impact of 6 months of treatment with intragastric balloon on body fat and quality of life in obese individuals with metabolic syndrome. Health Qual Life Outcomes. 2017;15(1):211.CrossRef
2.
go back to reference Abdelaal M, le Roux CW, Docherty NG. Morbidity and mortality associated with obesity. Ann Transl Med. 2017;5(7):161.CrossRef Abdelaal M, le Roux CW, Docherty NG. Morbidity and mortality associated with obesity. Ann Transl Med. 2017;5(7):161.CrossRef
3.
go back to reference Arroyo-Johnson C, Mincey KD. Obesity epidemiology worldwide. Gastroenterol Clin N Am. 2016;45(4):571–9.CrossRef Arroyo-Johnson C, Mincey KD. Obesity epidemiology worldwide. Gastroenterol Clin N Am. 2016;45(4):571–9.CrossRef
4.
go back to reference Bray GA, Frühbeck G, Ryan DH, et al. Management of obesity. Lancet. 2016;387(10031):1947–56.CrossRef Bray GA, Frühbeck G, Ryan DH, et al. Management of obesity. Lancet. 2016;387(10031):1947–56.CrossRef
5.
go back to reference Imaz I, Martínez-Cervell C, García-Álvarez EE, et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008;18(7):841–6.CrossRef Imaz I, Martínez-Cervell C, García-Álvarez EE, et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008;18(7):841–6.CrossRef
6.
go back to reference 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.CrossRef 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.CrossRef
7.
go back to reference Messina T, Genco A, Favaro R, et al. Intragastric balloon positioning and removal: sedation or general anesthesia? Surg Endosc. 2011;25(12):3811–4.CrossRef Messina T, Genco A, Favaro R, et al. Intragastric balloon positioning and removal: sedation or general anesthesia? Surg Endosc. 2011;25(12):3811–4.CrossRef
8.
go back to reference 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.CrossRef 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.CrossRef
9.
go back to reference 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.PubMed 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.PubMed
10.
go back to reference Mairs R, Nicholls D. Assessment and treatment of eating disorders in children and adolescents. Arch Dis Child. 2016;101(12):1168–75.CrossRef Mairs R, Nicholls D. Assessment and treatment of eating disorders in children and adolescents. Arch Dis Child. 2016;101(12):1168–75.CrossRef
11.
go back to reference Bryant-Waugh RJ, Cooper PJ, Taylor CL, et al. The use of the eating disorder examination with children: a pilot study. Int J Eat Disord. 1996;19(4):391–7.CrossRef Bryant-Waugh RJ, Cooper PJ, Taylor CL, et al. The use of the eating disorder examination with children: a pilot study. Int J Eat Disord. 1996;19(4):391–7.CrossRef
12.
go back to reference Ienca R, al Jarallah M, Caballero A, et al. The procedureless Elipse gastric balloon program: multicenter experience in 1770 consecutive patients. Obes Surg. 2020;30(9):3354–62.CrossRef Ienca R, al Jarallah M, Caballero A, et al. The procedureless Elipse gastric balloon program: multicenter experience in 1770 consecutive patients. Obes Surg. 2020;30(9):3354–62.CrossRef
13.
go back to reference 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 (Silver Spring). 2013;21(8):1561–70.CrossRef 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 (Silver Spring). 2013;21(8):1561–70.CrossRef
14.
go back to reference Dumonceau JM. Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg. 2008;18(12):1611–7.CrossRef Dumonceau JM. Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg. 2008;18(12):1611–7.CrossRef
15.
go back to reference Yap Kannan R, Nutt MR. Are intra-gastric adjustable balloon system safe? A case series. Int J Surg Case Rep. 2013;4(10):936–8.CrossRef Yap Kannan R, Nutt MR. Are intra-gastric adjustable balloon system safe? A case series. Int J Surg Case Rep. 2013;4(10):936–8.CrossRef
16.
go back to reference Di Saverio 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(10):1830–2.CrossRef Di Saverio 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(10):1830–2.CrossRef
17.
go back to reference Matar ZS, Mohamed AA, Abukhater M, et al. Small bowel obstruction due to air-filled intragastric balloon. Obes Surg. 2009;19(12):1727–30.CrossRef Matar ZS, Mohamed AA, Abukhater M, et al. Small bowel obstruction due to air-filled intragastric balloon. Obes Surg. 2009;19(12):1727–30.CrossRef
18.
go back to reference Mion F, Ibrahim M, Marjoux S, et al. Swallowable Obalon® gastric balloons as an aid for weight loss: a pilot feasibility study. Obes Surg. 2013;23(5):730–3.CrossRef Mion F, Ibrahim M, Marjoux S, et al. Swallowable Obalon® gastric balloons as an aid for weight loss: a pilot feasibility study. Obes Surg. 2013;23(5):730–3.CrossRef
19.
go back to reference Roman S, Napoléon B, Mion F, et al. Intragastric balloon for “non-morbid” obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg. 2004;14(4):539–44.CrossRef Roman S, Napoléon B, Mion F, et al. Intragastric balloon for “non-morbid” obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg. 2004;14(4):539–44.CrossRef
20.
go back to reference Loffredo A, Cappuccio M, de Luca M, et al. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg. 2001;11(3):330–3.CrossRef Loffredo A, Cappuccio M, de Luca M, et al. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg. 2001;11(3):330–3.CrossRef
21.
go back to reference Alsabah S, al Haddad E, Ekrouf S, et al. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis. 2018;14(3):311–7.CrossRef Alsabah S, al Haddad E, Ekrouf S, et al. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis. 2018;14(3):311–7.CrossRef
22.
go back to reference 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. 2018;28(2):405–9.CrossRef 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. 2018;28(2):405–9.CrossRef
23.
go back to reference Nainggolan L FDA on adverse events with ReShape, O.I.-g.B.m.i.t.I.N.Y.M.c.A.A.f. Nainggolan L FDA on adverse events with ReShape, O.I.-g.B.m.i.t.I.N.Y.M.c.A.A.f.
24.
go back to reference Raftopoulos I, Giannakou A. The Elipse balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis. 2017;13(7):1174–82.CrossRef Raftopoulos I, Giannakou A. The Elipse balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis. 2017;13(7):1174–82.CrossRef
Metadata
Title
Outcomes of a Swallowable Intragastric Balloon (Elipse™) on 96 Overweight and Obese Patients
Authors
Osama Taha
Mahmoud Abdelaal
Awny Asklany
Mohamed Alaa
Sherif Belal
Islam El.Assal
Maha Shahin
Ahmed Abubasha
Dalia Elbanhawy
Publication date
01-03-2021
Publisher
Springer US
Published in
Obesity Surgery / Issue 3/2021
Print ISSN: 0960-8923
Electronic ISSN: 1708-0428
DOI
https://doi.org/10.1007/s11695-020-05086-y

Other articles of this Issue 3/2021

Obesity Surgery 3/2021 Go to the issue