Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients.
NCT ID: NCT06360679
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-01-29
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BariTon™ System implantation
Endoscopic gastric restriction and biliodigestive diversion
The BariTon™ is endoscopically implanted and retrieved once treatment is completed
Interventions
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Endoscopic gastric restriction and biliodigestive diversion
The BariTon™ is endoscopically implanted and retrieved once treatment is completed
Eligibility Criteria
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Inclusion Criteria
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
25 Years
60 Years
ALL
Yes
Sponsors
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BariaTek Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Adrian Sartoretto, Dr
Role: PRINCIPAL_INVESTIGATOR
The BMI Clinic
Locations
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BMI Clinic Double Bay
Sydney, New South Wales, Australia
BMI Clinic Liverpool
Sydney, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIP000004
Identifier Type: -
Identifier Source: org_study_id
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