ObesityNCT06360679
Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients.
A study testing Endoscopic gastric restriction and biliodigestive diversion in people with Obesity, run by BariaTek Medical at 2 sites in Australia.
Trial summary
Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Endoscopic gastric restriction and biliodigestive diversion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustralia
- Study dates
- 29 Jan 2024to 1 Jun 2025
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects aged between 25 and 60 years inclusive
- A BMI between 30.0 and 40.0 kg/m2 inclusive with a history of obesity for at least 2 years and a history of failure of supervised weight loss program
- Stable weight, i.e. < 5% change in body weight for minimum of 3 months prior to enrolment
- Willing and able to provide written informed consent
- Willing and able to comply with the study procedures and follow-up schedule
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
BMI Clinic Double Bay
Sydney, New South Wales, 2028
Adrian Sartoretto, Dr, 0290534688 ext. 61, info@bmiclinic.com.au
- Recruiting
BMI Clinic Liverpool
Sydney, New South Wales, 2170
Adrian Sartoretto, Dr, 0290534688 ext. 61, info@bmiclinic.com.au
About this study
Official title: Clinical Feasibility Study of the BariTon™ System in Obese or Overweight (BMI > 27) Patients
Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device.
- Conditions
- Obesity
- Being tested
- Endoscopic gastric restriction and biliodigestive diversion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic gastric restriction and biliodigestive diversionDevice
The BariTon™ is endoscopically implanted and retrieved once treatment is completed
| Study group | Role | What they receive |
|---|---|---|
| BariTon™ System implantation | Experimental | Not described Receives: Device: Endoscopic gastric restriction and biliodigestive diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the BariTon™
Number of patients with device implantation procedure success
Measured: 3 months
Safety of the BariTon™
Incidence of device related adverse events
Measured: 3 months
Secondary outcomes (8)
Safety of the BariTon™
Number of patients with device retrieval procedure success
Measured: 1 year
Safety of the BariTon™
Incidence of device related adverse events
Measured: 1 year
Efficacy of the BariTon™
Assessment of clinical variables and other metrics (exploratory)
Measured: 1 year
Efficacy of the BariTon™
Changes and number of diabetes medication taken
Measured: 1 year
Efficacy of the BariTon™
Changes and number of statins medication taken
Measured: 1 year
Efficacy of the BariTon™
Changes and number of blood pressure lowering medication taken
Measured: 1 year
Efficacy of the BariTon™
Score changes in Weight related Quality of Life using IWQOL-Lite Questionnaire
Measured: 1 year
Efficacy of the BariTon™
Score changes in food craving using CoEQ Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start29 Jan 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jun 2025 (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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BariaTek Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Sartoretto, Dr, Principal investigator, The BMI Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360679
- Sponsor's protocol ID
- CIP000004
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility Study of the BariTon™ System in Obese or Overweight (BMI > 27) Patients
- ClinicalTrials.gov ID
- NCT06360679
- Acronym / sponsor ID
- CIP000004
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- BariaTek MedicalIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 11 Apr 2024 (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.
Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BariTon™ System implantation | Experimental | Device: Endoscopic gastric restriction and biliodigestive diversion |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects aged between 25 and 60 years inclusive
- A BMI between 30.0 and 40.0 kg/m2 inclusive with a history of obesity for at least 2 years and a history of failure of supervised weight loss program
- Stable weight, i.e. < 5% change in body weight for minimum of 3 months prior to enrolment
- Willing and able to provide written informed consent
- Willing and able to comply with the study procedures and follow-up schedule
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Endoscopic gastric restriction and biliodigestive diversionThe BariTon™ is endoscopically implanted and retrieved once treatment is completed | Device | BariTon™ System implantation |
Primary outcome
Safety of the BariTon™
Time frame: 3 months
Number of patients with device implantation procedure success
Safety of the BariTon™
Time frame: 3 months
Incidence of device related adverse events
8 secondary outcomes
Safety of the BariTon™
Time frame: 1 year
Safety of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
Adrian Sartoretto, Dr principal investigator
The BMI Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic gastric restriction and biliodigestive diversion in people with Obesity, run by BariaTek Medical at 2 sites in Australia.
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 5 inclusion and 0 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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 Christophe Naz (0180206755 ext. 33, christophe.naz@bariatek-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the BariTon™ (time frame: 3 months). The study lists 2 primary outcomes in all. 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 11 Apr 2024.