ObesityNCT03760861
First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule
A study testing Prototype Microcapsule Treatment in people with Obesity, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Prototype Microcapsule Treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Dec 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Khek Yu Ho, MD, 65 67795555, khek_yu_ho@nuhs.edu.sg
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Prototype Microcapsule Treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype Microcapsule TreatmentDevice
Also called Prototype weight-loss microcapsule placement in stomach
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.
| Study group | Role | What they receive |
|---|---|---|
| Prototype Microcapsule Treatment Arm | Experimental | 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.. Receives: Device: Prototype Microcapsule Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start13 Dec 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label pilot study
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Khek Yu Ho, MD, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760861
- Sponsor's protocol ID
- 2018/00018
- Other IDs
- 2018
- Status last verified
- Dec 2018
- First submitted
- 26 Apr 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule
- ClinicalTrials.gov ID
- NCT03760861
- Acronym / sponsor ID
- 2018/00018
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label pilot study
| Arm | Type | Receives |
|---|---|---|
| Prototype Microcapsule Treatment Arm | Experimental | Device: Prototype Microcapsule TreatmentIntervention 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.. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype Microcapsule TreatmentAlso: Prototype weight-loss microcapsule placement in stomachThe 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. | Device | Prototype Microcapsule Treatment Arm |
Primary outcome
Successful inflation and maintenance of the fully inflated intragastric balloon.
Time frame: 10 minutes
A fully inflated intragastric balloon in the stomach that is maintained for at least 10 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khek Yu Ho, MD principal investigator
National University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype Microcapsule Treatment in people with Obesity, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khek Yu Ho, MD (65 67795555, khek_yu_ho@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful inflation and maintenance of the fully inflated intragastric balloon. (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.