Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of U.S. commercialization

doi:10.1016/j.soard.2018.12.007

Surgery for Obesity and Related Diseases

Volume 15, Issue 3, March 2019, Pages 417-423

https://doi.org/10.1016/j.soard.2018.12.007 Get rights and content

Highlights

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Endoscopic Bariatric Therapies are a new class of obesity treatment options including devices that require endoscopy for placement or removal, including intragastric balloons that are space-occupying devices in the stomach.
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Randomized controlled trials with intragastric balloons have demonstrated significantly more weight loss with the intragastric balloons plus lifestyle therapy compared with lifestyle therapy alone.
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This manuscript describes safety and effectiveness data collected from a swallowable gas-filled intragastric balloon in the first year of availability in the United States collected in a registry made available to all treating physicians.

Abstract

Background

Obesity is the most common chronic disease in the United States today. Additional therapies are needed to improve obesity treatment.

Objective

A swallowable, gas-filled intragastric balloon system was approved for the treatment of obesity by Food and Drug Administration in September 2016 and commercialization started January 2017. A registry was made available to physicians to capture evidence of safety and effectiveness with use.

Setting

United States private clinics, surgery centers, and hospitals.

Methods

This study is a retrospective analysis of a prospective registry of patients with body mass index (BMI) ≥25 kg/m² that initiated therapy in the first year. Data on demographics, procedural timing, weight loss, adverse events, and device deficiencies were captured.

Results

The final analysis comprised 1343 patients across 108 treating physicians (mean age 45.7 ± 10.8 yr, 78.6% female, baseline BMI of 35.4 ± 5.4 kg/m²). Nonserious and serious adverse events were reported in 14.2% and .15% of patients, respectively. There were 7 balloon deflations, none caused obstruction. Weight loss in the indicated use (BMI 30–40 kg/m²) was 9.7 ± 6.1 kg and 10.0 ± 6.1% total body weight loss (TBWL). Weight loss in other BMI categories was 8.2 ± 5.6 kg or 10.3 ± 7.0% total body weight loss for BMI 25 to 29.9 kg/m² and 11.6 ± 7.8 kg or percent total body weight loss 9.3 ± 6.0 for BMI >40 kg/m².

Conclusions

This swallowable gas-filled intragastric balloon system is safe and effective at inducing weight loss and offers physicians another tool for patients whose obesity has been resistant to noninvasive treatments.

Graphical abstract

Section snippets

Patients

This study was a retrospective analysis of a prospectively maintained database of consecutive OBS of patients with a starting BMI ≥25 kg/m² (overweight or obese) who initiated therapy during the first year of commercialization (January through December 2017) at 108 participating centers and had balloon removal data entered by August 28, 2018. Each participating center in the registry had at least 1 patient, and no centers contributed >5% of the data set. All patients treated at each site were

Participants

OBS therapy was initiated and patient data entered in 1387 patients. Forty-four patients (3.2%) were excluded from the analysis; 36 patients were entered but had no balloon removal information at database cutoff of August 28, 2018, and 8 patients had a starting BMI <25 kg/m². The remaining 1343 (age 45.7 ± 10.8, weight 99.6 ± 19.5 kg, BMI 35.4 ± 5.4) patients are included in the analyses, which represents 96.8% of the patients in the registry. Of the patients, 78.6% were women, 66.8% were

Discussion

This article describes the outcome data collected from the largest known registry of an approved endoscopic bariatric therapy to date [9], [10] and provides evidence of effective weight loss and safety in clinical use. The weight loss seen in this cohort of patients on average is consistent with weight loss levels that have been shown to reduce risk of cardiovascular disease and improve nonalcoholic fatty liver disease [11], [12], [13]. The rate of serious AEs in this registry was lower than

Conclusion

Evidence collected in the registry across >100 treating physicians and >1000 patients demonstrates a continued favorable risk–benefit profile with a lower serious AE rate than seen in the clinical trial and low nonserious AE rate. Moreover, data from this registry show increased weight loss compared with the multicenter, double-blind, sham-controlled trial, which is consistent with studies investigating other endoscopic weight loss devices or procedures. The commercial availability of the OBS

Disclosures

Rachel Moore: contracted research and consulting Obalon Therapeutics and Apollo Endosurgery; contracted research for Allurion Technologies and Elira Therapeutics, consulting for Olympus and Medtronic; Michael Seger: contracted research and consultant for Obalon Therapeutics; Shawn Garber: contracted research for Obalon Therapeutics, Reshape Medical, consultant for Medtronic, stockholder for Virtual Health Partners; Adam Smith: contracted research for Obalon Therapeutics; Richard Nguyen:

Ethical approval

This study received a Waiver of Informed Consent from Advarra IRB (Chesapeake, VA) in accordance with 45 CFR 46.116(d), General requirements for Informed consent. Additionally, patient confidentiality was maintained per HIPAA criteria.

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Although obesity affects over 40% of adults in the United States and is a driver of preventable chronic diseases and health care costs, most patients are left untreated.
This was a randomized, double-blind, sham-controlled trial to investigate the safety and efficacy of a novel, endoscopically placed intragastric device for weight reduction, the TransPyloric Shuttle, implanted for 1 year in 270 patients with Class I and II obesity. An additional 32 treatment patients were enrolled in an Open-Label group. The co-primary efficacy endpoints were percent total body weight loss (%TBWL) in the Treatment group compared with the Sham group and a proportion of treatment patients achieving ≥5% TBWL at 12 months.
The mean %TBWL at 12 months was 9.5% (95% CI, 8.2-10.8) in the Treatment group (n = 181) compared with 2.8% (95% CI, 1.1-4.5) in the Sham group (n = 89). In the Treatment group, 67.0% (95% CI, 59.3-74.4) of patients achieved ≥5% TBWL compared with 29.3% (95% CI, 19.3-39.4) in the Sham group. Patients in the Treatment group achieved lower blood pressure, total cholesterol, and low-density lipoprotein cholesterol compared with the Sham group. Early withdrawals occurred in 22% and 11% patients in the Treatment and Sham groups, respectively. Device- or procedure-related serious adverse events occurred in 6 patients (2.8%), and no deaths occurred.
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AGA Technical Review on Intragastric Balloons in the Management of Obesity
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In 2015, Abu Dayyeh and colleagues94 performed a systematic review and meta-analysis of IGB-related complications (reported in an observational data manner) illustrating 1.4% migration, 0.1% gastric perforation (4 of 8 in patients with previous gastric surgery), and 0.08% mortality (4 due to gastric perforation or aspiration pneumonia) from 68 studies using the Orbera balloon (both RCT and observational data). Furthermore, both FDA-commissioned and investigator-initiated post-marketing surveillance studies have not demonstrated a significant mortality rate associated with IGB when the therapy is administered within the context of a comprehensive obesity care program with close patient follow-up.95–97 There was limited evidence from RCT data for the efficacy of IGB for the treatment of obesity comorbidities, as most of the RCTs were conducted in patients with no or mild comorbidities.
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.
Endoscopic Balloon Therapy
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Outcome comparisons between these trials should be interpreted with caution, as knowledge of treatment group in open-label RCTs has been shown to impact weight loss when compared to trials of blinded subjects.13 Weight loss at balloon removal in the retrospective postregulatory trial of the Orbera was 11.8%, similar to those reported in the postregulatory trials of the ReShape Duo (11.4%) and Obalon (10.0)% balloons (see Table 3).34–36 Accommodative symptoms were common after balloon placement in the pivotal RCT, because 75% to 80% of patients experienced nausea and vomiting that was generally self-limited, although dehydration occurred in 14.4% of IGB patients.
New technologies and advances in weight loss therapy
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La cirugía bariátrica es el tratamiento más efectivo para tratar la obesidad y sus comorbilidades, sin embargo, hay barreras que evitan que estas sean aceptadas de forma generalizada. Ante la creciente epidemia de obesidad, surge la necesidad de crear nuevos tratamientos menos invasivos, los cuales deben tener un amplio margen de seguridad y efectividad para condicionar pérdida de peso, al menos mayor que un tratamiento basado en dieta y ejercicio. Estos incluyen dispositivos que se colocan y retiran por endoscopía y se clasifican en: dispositivos ocupativos, procedimientos restrictivos o remodelantes de la anatomía, bypass endoluminal y remodelación duodenal. También se dispone de técnicas percutáneas y de cirugías «menos» invasivas.
En general, los resultados obtenidos muestran mejoría en el metabolismo de la glucosa de los pacientes diabéticos y en cuanto a la pérdida de peso, aunque no superan a la cirugía bariátrica, se observan resultados que tienen mayor alcance si se comparan con el tratamiento conservador (dieta y ejercicio). La tasa de eventos adversos es baja. El uso clínico de una nueva tecnología debe practicarse dentro de un programa de manejo multidisciplinario que incluya soporte nutricional, psicológico, deportivo, y médico. Es de suma importancia reconocer que estas terapias no son creadas para sustituir a la cirugía bariátrica, sino para aumentar las opciones de tratamientos y generar mayor alcance e impacto en la población general. Este trabajo tiene por objeto una revisión actualizada de la literatura sobre tecnologías emergentes para el tratamiento de la obesidad.
Bariatric surgery is the most effective treatment for obesity and its comorbidities but there are barriers that prevent its general acceptance. The growing obesity epidemic has resulted in the need for the creation of new, less invasive treatments, with a wide margin of safety and effectiveness for conditioning weight loss, at least greater than that resulting from treatment based on diet and exercise. Emerging therapies include devices that are endoscopically placed and removed, classified as: space-occupying devices, restrictive or anatomic-remodeling procedures, endoluminal bypass, and duodenal mucosal resurfacing. Percutaneous techniques and less invasive surgeries are also included.
In general, results have shown improvement in glucose metabolism in diabetic patients. With respect to weight loss, results do not surpass those of bariatric surgery, but are better than results with conservative treatment (diet and exercise) and have a low rate of adverse events. Clinical use of a new technique should be carried out within a multidisciplinary management program that includes nutritional, psychologic, physical activity, and medical support. It must be understood that novel therapies are not being created to substitute bariatric surgery, but rather to increase treatment options in the general population, with greater reach and impact. The aim of the present study was to provide an up-to-date literature review on emerging technologies for the treatment of obesity.
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The benefits of EBMTs are discussed in other parts of this series of articles. When used as monotherapy, however, EBMTs have been somewhat limited by modest weight loss and metabolic benefits, weight regain, variable patient satisfaction, and minimal (if any) insurance coverage [5-11]. This is similar to monotherapy with obesity pharmacotherapy, for which modest outcomes and poor insurance coverage have also limited utilization.
Endoscopic bariatric and metabolic therapies (EBMT) are rarely used in the United States. Compared with EBMTs alone, combining EBMTs with obesity pharmacotherapy may increase the magnitude and durability of weight loss and ultimately may contribute to increased patient satisfaction and EBMT utilization. Though combination therapy is frequently used in clinical practice, few published studies of combination EBMT/pharmacotherapy are available. Available studies and abstracts suggest that combination strategies are promising, but further research and clinical trials are needed. This article will review available obesity pharmacotherapy options and describe current data on combining EBMT and pharmacotherapy.
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Similarly to the Reshape trial, the utilization of the Obalon intragastric devices provided a near double TBWL as compared with control groups. Furthermore, in a recent prospective analysis of 1343 patients with a BMI ≥25 who were treated with the Obalon balloon in the first year of its commercialization, the device was found to have a lower incidence of serious adverse events (0.15% vs 0.30%) and increased weight loss compared with the results of the SMART trial.19 The most effective weight loss was seen in patients treated with 3 balloons (n = 1103 patients; 9.8 ± 9.5 kg, 9.9 ± 9.7% TBWL, and 42.3 ± 35.2% EWL).

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¹: The Registry was funded by Obalon, Inc., Carlsbad, CA, USA. No authors received contracted research support through their institutions from Obalon, Inc. to support this manuscript. Data analysis was conducted by Obalon, Inc. and reviewed by the authors.

²: This study is registered at clinicaltrials.gov; ID NCT03688256.

View full text

Original articleClinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of U.S. commercialization1,2

Highlights

Abstract

Background

Objective

Setting

Methods

Results

Conclusions

Graphical abstract

Section snippets

Patients

Participants

Discussion

Conclusion

Disclosures

Ethical approval

Gastroenterology

Surg Obes Relat Dis

Surg Obes Relat Dis

Cell Metab

ReShape Integrated Dual Balloon System-PMA P140012

FDA Summary of safety and effectiveness data (SSED) [monograph on the Internet]

Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial

Int J Obes

Orbera-PMA P140008

FDA summary of safety and effectiveness data (SSED) [monograph on the Internet]

Obalon Balloon System-PMA P160001

FDA summary of safety and effectiveness data (SSED) [monograph on the Internet]

Original article
Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of U.S. commercialization1,2