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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03760861
Other study ID # 2018/00018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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