Status:
UNKNOWN
First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
Nanyang Technological University
Conditions:
Obesity
Eligibility:
All Genders
21-50 years
Phase:
NA
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 infla...
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 inflati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03760861
Start Date
December 13 2018
End Date
December 31 2019
Last Update
December 17 2018
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119074