NCT03760861

First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to demonstrate the ease of deployment of a novel magnetically-controlled ingestible weight loss microcapsule\* and the functionality of the magnetically controlled inflation of the balloon within the stomach.

Detailed description

The objective of this study is to demonstrate the ease of deployment of a novel magnetically-controlled ingestible weight loss microcapsule and the functionality of the magnetically controlled inflation of the balloon within the stomach. Device comes in the form of a gelatine coated pill (Ø9.6mm x 27mm) . Once in the stomach, the device may be driven by external magnetic controllers which can control both its position and orientation. It allows flexible approach of the external magnetic fields in any axial directions of the device, and it also controls the inflation valve which controls the inflation of an attached balloon. The inflated balloon will partially fill up the stomach, giving the subject the feel of satiety to reduce his/her desire to eat more food.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Prototype Microcapsule Treatment	The subject will be sedated and using an endoscope, a prototype microcapsule will be placed into the gastric corpus. Then, an external handheld magnet will be applied to inflate the balloon encapsulated in the microcapsule. Upon ascertaining the full inflation based on the endoscopic visualization, the investigator will wait another 10 minutes after that to observe how the subject feels before manually puncturing the balloon with needle knife, and retrieving the punctured balloon with the RothNet through the mouth.

Timeline

• Start date: 2018-12-13
• Primary completion: 2019-12-01
• Completion: 2019-12-31
• First posted: 2018-11-30
• Last updated: 2018-12-17

Locations

1 site across 1 country: Singapore