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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03760861
• Other study ID #: 2018/00018
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2018
• Source: National University Hospital, Singapore
• Contact: Khek Yu Ho, MD
• Phone: 65 67795555
• Email: khek_yu_ho[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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