Clinical trial NCT03760861: First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule
Official title: First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Nanyang Technological University
First posted: 2018-11-30
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label pilot study
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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

Primary outcomes:
measure: Successful inflation and maintenance of the fully inflated intragastric balloon.
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Health System
name: Khek Yu Ho, MD
role: PRINCIPAL_INVESTIGATOR
References: