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

NCT03760861 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-12-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nanyang Technological University

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Khek Yu Ho, MD · National University Health System

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2019-12-01
Completion
2019-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760861 on ClinicalTrials.gov