Table 1.

Prospective, Randomized Controlled Trials of Intragastric Balloons

IGB device	Study	Country	IGB implant time (wk)	Number of subjects		%EWL	%TBWL	BMI loss (kg/m2)	p-value
				n (total)	Study arm
Orbera	Genco et al. (2006) [39]	Italy	12	32	16 (IGB + diet)	34.0±4.8	NR	5.8±0.5	<0.001 (%EWL)
					16 (sham + diet)	2.1±1.0		0.4±0.2
Orbera	Konopko-Zubrzycka et al. (2009) [40]	Poland	24	36	21 (IGB)	NR	12.3	NR	<0.001
					15 (diet + exercises)		2.3
Orbera	Peker et al. (2011) [44]	Turkey	24	32	16 (IGB)	39.3	NR	NR	0.189
					16 (laparoscopic band)	32.3
Orbera	Farina et al. (2012) [41]	Italy	24	50	30 (IGB + diet + exercise)	NR	14.5±1.2	NR	<0.05
					20 (sibutramine + diet + exercise)		9.1±1.5
Orbera	Lee et al. (2012) [42]	Singapore	24	18	8 (IGB + diet + exercise)	NR	NR	1.69±0.89	<0.001
					10 (sham + diet + exercise)			0.54±0.54
Orbera	Fuller et al. (2013) [43]	Australia	24	66	31 (IGB + behavioral modification)	50.3	14.2	5.1	<0.001 (%EWL)
					35 (behavioral modification alone)	16.9	4.8	1.7
Rehape Duo	Ponce et al. (2015) [45]	USA	24	326	187 (IGB + diet + exercise)	25.1±1.6	7.6±5.5	2.7±1.9	0.004 (%EWL)
					139 (sham + diet + exercise)	11.3±1.9	3.6±6.3	1.3±2.3
Obalon	Sullivan et al. (2018) [46]	USA	24	387	198 (IGB + exercise)	23.9±19.2	6.6±5.1	2.3±1.8	<0.001 (%EWL)
					189 (sham + exercise)	12.4±18.8	3.4±5.0	1.2±1.8

BMI, body mass index; %EWL, % excess weight loss; IGB, intragastric balloon; NR, not reported; %TBWL, % total body weight loss.