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

National University Health System (NUHS)

Status: Unknown

Conditions: Obesity

Treatments: Device: Prototype Microcapsule Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03760861

2018/00018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 estimated patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Healthy subject, as evidenced by medical history
• Male or female aged 21-50 years of age
• Willing to undergo endoscopy to retrieve the balloon and to comply with all study procedures
• Ability to provide a signed and dated informed consent form

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Prototype Microcapsule Treatment Arm

Experimental group

Description:

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..

Treatment:

Device: Prototype Microcapsule Treatment