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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Device: Prototype Microcapsule Treatment

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 Type: Interventional
• Enrollment (Anticipated): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khek Yu Ho, MD; Phone Number: 65 67795555; Email: khek_yu_ho@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Contact: Khek Yu Ho, MD; Phone Number: 65 67795555; Email: khek_yu_ho@nuhs.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prototype Microcapsule Treatment Arm; 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..

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.; Other Names: Prototype weight-loss microcapsule placement in stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful inflation and maintenance of the fully inflated intragastric balloon.	A fully inflated intragastric balloon in the stomach that is maintained for at least 10 minutes.	10 minutes

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: Nanyang Technological University
• Investigators: Principal Investigator: Khek Yu Ho, MD, National University Health System

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2018/00018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No