Page 36 - Read Online

Page 10 of 20 Nwaiwu et al. Mini-invasive Surg. 2025;9:20 https://dx.doi.org/10.20517/2574-1225.2024.112

[44]
heavier weight. It is placed endoscopically and remains in situ for up to 6 months .
TM
The Elipse balloon: a non-endoscopic, procedure-free IGB that eliminates the need for endoscopic
placement or removal. It is compacted into an ingestible vegan capsule attached to a slender catheter,
allowing it to be filled with 550 mL of liquid once it reaches the stomach, typically during an outpatient visit.
Placement is confirmed via abdominal X-ray, after which the catheter is removed. After about 4 months, the
balloon self-empties through a built-in valve and is naturally excreted via the GI tract . This device is
[52]
currently being evaluated by the FDA.

Overall safety and efficacy of IGBs
One meta-analysis of RCTs comparing IGB with sham or lifestyle interventions in patients who are
overweight or who have obesity found a significantly higher EWL (17.98%) and TBWL (4.4%) in the IGB
group . Sub-group analysis demonstrated no significant difference in EWL between balloon types, but the
[53]
Spatz balloon was found to have the greatest effect on the observed higher TBWL than other balloon types
(Obalon, Orbera, and ReShape Duo).

Another meta-analysis of 5,668 patients showed that IGBs are more effective than lifestyle changes alone in
improving obesity-related metabolic parameters such as triglyceride (-19 mg/dL), waist circumference
(-4.1 cm), diastolic blood pressure (-2.9 mmHg), and fasting plasma glucose) levels (FPG, -12.7 mg/dL) with
[54]
a 1.4% odds of diabetes resolution and a low adverse event rate (1.3%) .

Serious adverse events reported in studies include perforation (0.3%), esophageal mucosal injury (0.8%),
gastric ulcer or bleeding (0.76%), severe dehydration (0.7%), aspiration pneumonia (0.4%), and gastric
outlet/bowel obstruction (0.12%) . No mortality was reported in a review of studies including 741
[55]
patients . Complications reported by the US FDA in post-approval studies include balloon hyperinflation
[55]
(2.3%), mostly from the Orbera balloon, and acute pancreatitis (1.3% from ReShape). Additional reports
include more episodes of pancreatitis from Orbera than from Reshape [55,56] . These complications often led to
early balloon removal. Hyperinflation or acute pancreatitis were not reported with the gas-filled Obalon
system.

Fluid-filled vs. air-filled IGB
A meta-analysis of 22 RCTs evaluating 6-month %TBWL outcomes found that fluid-filled IGBs resulted in
[55]
2.8% more weight loss compared to gas-filled balloons . Contraindications to IGB include but are not
limited to prior bariatric surgery, any inflammatory disease of the GI tract (e.g., esophagitis, gastric
ulceration, duodenal ulceration, cancer, or specific inflammation such as Crohn’s disease), presence of a
gastric mass, hiatal hernia, and severe coagulopathy [46,49] .

TPS
The TPS (BARONova Inc, San Carlos, CA, USA) is a removable intragastric device made up of a large
proximal bulb connected by a silicone tether to a smaller distal bulb. Delivered and assembled
endoscopically, the smaller bulb rests in the duodenum while the larger bulb remains in the stomach
[37]
[Figure 2D] . The device creates intermittent gastric outlet obstruction during peristalsis, delaying gastric
emptying and reducing food intake. TPS is designed to be used for 12 months, after which it is removed
endoscopically using the BAROnova Retrieval Kit . A recent double-blind RCT found that patients with
[57]
classes I and II obesity who received TPS therapy had a significantly higher TBWL than the control group
(9.5% vs. 2.8%) after 12 months. Sixty-seven percent of the treatment group achieved ≥ 5% TBWL,
compared to 29.3% in the control group. The treatment group also experienced significantly lower blood
pressure, total cholesterol, and low-density lipoprotein. Serious adverse events related to the device or
procedure occurred in 6 patients (2.8%), with no reported deaths . Of 213 patients, there was one
[58]