176 Pivotal Randomized-Controlled Trial of the Adjustable (Spatz-3) Intragastric Balloon System for Weight Loss

Dayyeh, Barham K. Abu; Noar, Mark D.; Lavin, Thomas K.; Hussan, Hisham; Chapman, Christopher G.; Popov, Violeta; Acosta, Andrés; French, Matthew S.; Rizk, Monika; Huseini, Mustafa; Grothe, Karen; Clark, Matthew M.; Vargas, Eric J.; Thompson, Christopher C.

doi:10.1016/j.gie.2019.04.020

Cited by 13 publications

(11 citation statements)

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“…The serious AEs rate was 5.3%, with a gastric ulcer rate of 4%. There were no reports of perforation, mortality, or balloon hyperinflation [45]. These results have already been submitted to the FDA, and clearance for the market shall be granted soon.…”

Section: Spatz3mentioning

confidence: 97%

“…Increasing the size of the device after reaching a plateau or in cases of weight loss failure seems tempting, primarily when adaptive symptoms are controlled. Limited reports describe additional weight loss [44,45], but until a sham-controlled trial focused on the adjustment, one should not reject the possible placebo effect as the primary contributor.…”

Section: Spatz3mentioning

confidence: 99%

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Gastric space-occupying devices for management of obesity and metabolic disease

Brunaldi

Neto

2020

Techniques and Innovations in Gastrointestinal Endoscopy

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Section: Spatz3mentioning

confidence: 97%

Section: Spatz3mentioning

confidence: 99%

Gastric space-occupying devices for management of obesity and metabolic disease

Brunaldi

Neto

2020

Techniques and Innovations in Gastrointestinal Endoscopy

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“…The pooled estimate for 6-8 months (single treatment duration) percent total body weight loss (%TBWL) was derived from 7 RCTs 27,28,[30][31][32][33][34] including 1341 patients (IGB: 7.1-14.9; SOC: 2.4-5.4; MD: 6.89; 95% CI, 4.09-9.70) (Supplementary Figure 5). Three RCTs were included for analysis of 9-month outcomes 27,28,33 with IGB %TBWL mean ranging from 7.5% to 10.9% and 3.4% to 5.5% in the SOC group (MD, 5.08%; 95% CI, 3.79%-6.37%) (Supplementary Figure 6).…”

Section: Percent Total Body Weight Lossmentioning

confidence: 99%

AGA Technical Review on Intragastric Balloons in the Management of Obesity

et al. 2021

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Several strategies are available to address the obesity epidemic and range from noninvasive lifestyle interventions to medications and bariatric surgical procedures. Endoscopic bariatric techniques, such as intragastric balloons, have become an attractive alternative as a tool for weight loss that can augment the effect of lifestyle interventions. This technical review includes multiple systematic reviews performed to support a clinical practice guideline by the American Gastroenterological Association on the role of intragastric balloons as a tool for weight loss. The systematic reviews targeted a priori selected clinical questions about the effectiveness and periprocedural care of intragastric balloons and concomitant and subsequent weight-loss strategies.

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“…Meanwhile, two balloons have been approved by the FDA for a 6‐month therapy in patients with a BMI 30–40 kg/m 2 with the requirement of supportive therapy for a total of 12 months: that is; (1) the Orbera balloon (formerly the BioEnterics Intragastric Balloon or BIB, Apollo Endosurgery) since 2015 13 , 14 ; and (2) the Obalon orally ingested intragastric balloon (Obalon Therapeutics) since 2016 15 16 Pivotal trials with two new and innovative balloon systems have just been finished and await approval by the FDA 17–19 …”

Section: Introductionmentioning

confidence: 99%

“…15,16 Pivotal trials with two new and innovative balloon systems have just been finished and await approval by the FDA. [17][18][19] However, the exact mechanism by which intragastric balloons induce weight loss is still not known. Intragastric balloons are hypothesized to mediate satiety peripherally, by being a physical impediment of food intake, by reducing the gastric capacity and by delaying gastric emptying, and centrally, by activating gastric stretch receptors that transmit signals via afferent vagal nerves, the solitary tract and paraventricular nuclei, to the ventromedial and lateral hypothalamus.…”

mentioning

confidence: 99%

Weight loss with or without intragastric balloon causes divergent effects on ghrelin cell expression

Mathus-Vliegen

Spångéus

Walter

et al. 2021

Obesity Science & Practice

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Objective: The mechanism of action of intragastric balloons in the treatment of obesity is not fully understood. One of the hypotheses is that balloons might have an effect on the fundus, the area of ghrelin production.Methods: Participants were randomized to a 13-week period of sham or balloon treatment followed by a 13-week period of balloon therapy in everyone. Blood samples for ghrelin levels were taken in the fasting state and after a breakfast at the start, after 13 and 26 weeks. Biopsies for ghrelin cell immunohistochemistry were taken from the fundus at endoscopy. Results:Seven participants entered the balloon-balloon (BB) group and 11 the sham-balloon (SB) group. Despite a considerable weight loss, a median À 17.9 kg (interquartile ranges À 23.8 to À 0.5) in the BB group and À 18.3 kg (À 22.7 to À 14.7) in the SB group, fasting ghrelin and meal-induced ghrelin response did not change.In the SB group, the number of ghrelin cells increased significantly (p 0.001) from 110.6 (83.6-118.9) to 160.2 (128.5-223.0) while on sham treatment and returned to initial levels, 116.3 (91.7-146.9) (p 0.001), when they received their first balloon.No significant changes in ghrelin cell numbers were observed in the BB group. Conclusion:In participants without a balloon, weight loss induced an increase in ghrelin cell numbers in the fundus, which was annulled by the subsequent placement of a balloon. The effect of a balloon might be explained by effects on ghrelin cell numbers or ghrelin cell activity.

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176 Pivotal Randomized-Controlled Trial of the Adjustable (Spatz-3) Intragastric Balloon System for Weight Loss

Cited by 13 publications

References 0 publications

Gastric space-occupying devices for management of obesity and metabolic disease

Gastric space-occupying devices for management of obesity and metabolic disease

AGA Technical Review on Intragastric Balloons in the Management of Obesity

Weight loss with or without intragastric balloon causes divergent effects on ghrelin cell expression

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