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

Primary Purpose

Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Prototype Microcapsule Treatment

About this trial

This is an interventional device feasibility trial for Obesity

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prototype Microcapsule Treatment Arm

Arm Description

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..

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03760861

First Posted

April 26, 2018

Last Updated

December 13, 2018

Sponsor

National University Hospital, Singapore

Collaborators

Nanyang Technological University

1. Study Identification

Unique Protocol Identification Number

NCT03760861

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 13, 2018 (Actual)

Primary Completion Date

December 1, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National University Hospital, Singapore

Collaborators

Nanyang Technological University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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 inflation of the balloon within the stomach.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open label pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prototype Microcapsule Treatment Arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Prototype Microcapsule Treatment

Other Intervention Name(s)

Prototype weight-loss microcapsule placement in stomach

Intervention Description

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.

Primary Outcome Measure Information:

Title

Successful inflation and maintenance of the fully inflated intragastric balloon.

Description

A fully inflated intragastric balloon in the stomach that is maintained for at least 10 minutes.

Time Frame

10 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Khek Yu Ho, MD

Phone

65 67795555

khek_yu_ho@nuhs.edu.sg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khek Yu Ho, MD

Organizational Affiliation

National University Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University Hospital

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Khek Yu Ho, MD

Phone

65 67795555

khek_yu_ho@nuhs.edu.sg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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