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

Not Applicable

• Conditions: Obesity
• Interventions: Device: Prototype Microcapsule Treatment

• Registration Number: NCT03760861
• Lead Sponsor: National University Hospital, Singapore

Brief 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.

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Status Verified: 2018-12
• Study Start: 2018-12-13
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2018-12-17
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

• Individuals with anatomical abnormalities or functional disorders that may inhibit swallowing or passage through to the stomach
• Individuals with history or symptoms of clinically significant esophageal or gastric disorders, peptic ulcerations, hiatal hernia, patulous pyloric channel, erosive esophagitis, varices, angiectasia, Barrett's esophagus
• Individuals with bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease
• Individuals with bleeding disorders
• Individuals already having other bioenteric devices placed
• Individuals who have pace makers, metal implants or other devices on them
• Pregnant women
• Individuals unable to make/sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prototype Microcapsule Treatment Arm	Prototype Microcapsule Treatment	Intervention by placement of prototype weight-loss microcapsule in the stomach. Subjects will have a weight-loss microcapsule deployed endoscpically in the stomach. The intragastric balloon in the capsule will be inflated using an external magnet..

Primary Outcome Measures

Name	Time	Method
Successful inflation and maintenance of the fully inflated intragastric balloon.	10 minutes	A fully inflated intragastric balloon in the stomach that is maintained for at least 10 minutes.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore