Novel ingestible gastric balloon holds promise for weight loss

A study from Argentina shows the potential of an innovative ingestible gastric balloon, an intragastric device that does not require surgery, anaesthesia, or endoscopy, for weight management in individuals with obesity.

“In this study of nearly 500 patients, we report a 100-percent placement success rate, with an average weight loss of >14 percent sustained for 12 months in 86 percent of participants,” noted Drs Federico Davrieux and Mariano Palermo from the University of Buenos Aires, Argentina. “It is estimated that between 10 and 20 percent of weight was lost after completing the programme.”

The study was conducted at a single centre in Buenos Aires, Argentina, between January 2020 and January 2024. A total of 515 balloons were placed in 497 patients (mean age 39 years, 71 percent women, mean BMI 31.7 kg/m²). The mean balloon placement time was 20.2 min. [J Laparoendosc Adv Surg Tech A 2025;35:711-713]

Two-thirds of participants ingested the device with the operators’ assistance; 12 percent managed to do so on their own; and approximately a quarter did so using a stylet.

The most common adverse effect was reflux (52 percent), followed by abdominal pain (33 percent), asthenia (24 percent), and nausea and vomiting (22.9 percent). The average duration of symptoms was 36 hrs.

Complication rates were low, including intolerance (1.1 percent), hyperinflation (0.3 percent), catheter breakage upon removal (0.3 percent), and dehydration (0.5 percent). Intolerance and hyperinflation were managed by endoscopic balloon removal. “Patients who experienced dehydration required hospitalization [and] fluid rehydration,” Davrieux and Palermo noted.

There were no procedure-related deaths reported.

The balloon and its placement

The balloon is made of a flexible material to facilitate easy ingestion and is connected to a catheter that allows for inflation. According to the investigators, the balloon bears radiopaque markings for fluoroscopic control during placement.

Once inside the stomach, the intragastric balloon is filled with 550 cm³ of distilled water solution. Fluoroscopy is repeated to verify proper inflation. After placement, the catheter is removed, and the nutritional monitoring application is activated on the smart scale and smartwatch health monitor.

The balloon has a valve that progressively and spontaneously dissolves at 16 weeks, allowing fluid to escape into the gastric lumen. The empty, deflated balloon is then excreted.

Nonsurgical options favoured

One of the main therapeutic options for obesity is bariatric surgery. [Obes Surg 2013;23:1922-1933; Obes Surg 2016;26:1697-1704; Obes Surg 2015;25:2280-2289] However, despite its reported safety, it is not free from complications (fistulas, leaks, stenosis, and bleeding) and adverse effects (hypovitaminosis, dehydration, malnutrition, and dumping syndrome). [J Laparoendosc Adv Surg Tech A 2021;31:139-140; J Laparoendosc Adv Surg Tech A 2020;30:907-911] Hence, many individuals with obesity seek nonsurgical weight loss alternatives.

“[Our findings] show that this method is simple and effective, achieving great therapeutic success in patients with grade I and II obesity,” the investigators said. Moreover, the adverse effects can be partially or completely mitigated with specific medications such as antiemetics, antispasmodics, and analgesics.

Overall, the goal of intragastric balloon placement is to develop a weight-loss and lifestyle-change programme that enhances the quality of life (QoL) of patients with obesity, they noted.

Apart from patients with overweight or grade I and II obesity, the balloon may benefit those who have had futile attempts to lose weight, they added. “It should also be considered in patients with high BMI who do not wish to undergo surgery … [Despite the minimal improvement], it could have a positive impact on QoL.”