Early Termination of a First-in-Human Trial of a Swallowable Self-Expanding Intragastric Balloon (IGBalloon©) Due to Small Bowel Obstruction.

BACKGROUND

Swallowable intragastric balloons represent an evolving minimally invasive treatment option for obesity. The current first-in-human study evaluated the safety and efficiency of a novel swallowable self-expanding intragastric balloon (IGBalloon©) with a kidney-shaped design, intended to reduce the risk of migration.

SETTING

Single-center, prospective first-in-human study at a tertiary metabolic/bariatric center.

METHODS

This prospective open-label, non-randomized trial was designed to include 20 patients with obesity. Patients with a body mass index (BMI) >35 kg/m² or >30 kg/m² with at least one obesity-related complication were eligible. The primary endpoints were safety and efficacy, including weight loss and remission of obesity-related complications. Patients were allowed to ingest up to five balloons during follow-up.

RESULTS

Due to two severe adverse events (SAE), the trial was terminated prematurely after the inclusion of five patients. Two patients developed small bowel obstruction caused by balloon migration through the pylorus, requiring emergency laparoscopic enterotomy and balloon removal.

CONCLUSION

This first-in-human study demonstrated a substantial risk of balloon migration and small bowel obstruction associated with the current kidney-shaped IGBalloon© design. The device in its present form is not qualified for clinical use.