Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06360679




Registration number
NCT06360679
Ethics application status
Date submitted
7/03/2024
Date registered
11/04/2024
Date last updated
11/04/2024

Titles & IDs
Public title
Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients.
Scientific title
Clinical Feasibility Study of the BariTon™ System in Obese or Overweight (BMI > 27) Patients
Secondary ID [1] 0 0
CIP000004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Endoscopic gastric restriction and biliodigestive diversion

Experimental: BariTon™ System implantation -


Treatment: Devices: Endoscopic gastric restriction and biliodigestive diversion
The BariTon™ is endoscopically implanted and retrieved once treatment is completed
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of the BariTon™
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Safety of the BariTon™
Timepoint [2] 0 0
3 months
Secondary outcome [1] 0 0
Safety of the BariTon™
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Safety of the BariTon™
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Efficacy of the BariTon™
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Efficacy of the BariTon™
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Efficacy of the BariTon™
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Efficacy of the BariTon™
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
Efficacy of the BariTon™
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
Efficacy of the BariTon™
Timepoint [8] 0 0
1 year

Eligibility
Key inclusion criteria
1. Male and female subjects aged between 25 and 60 years inclusive

2. 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

3. Stable weight, i.e. < 5% change in body weight for minimum of 3 months prior to
enrolment

4. Willing and able to provide written informed consent

5. Willing and able to comply with the study procedures and follow-up schedule
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
BMI Clinic Double Bay - Sydney
Recruitment hospital [2] 0 0
BMI Clinic Liverpool - Sydney
Recruitment postcode(s) [1] 0 0
2028 - Sydney
Recruitment postcode(s) [2] 0 0
2170 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BariaTek Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and
biliodigestive diversion device.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06360679
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adrian Sartoretto, Dr
Address 0 0
The BMI Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christophe Naz
Address 0 0
Country 0 0
Phone 0 0
0180206755
Fax 0 0
Email 0 0
christophe.naz@bariatek-medical.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06360679