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A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention
The proposed study is a prospective, non-randomized, pilot study to test the impact of the Allurion Digital Behaviour Change Intervention (DBCI) in participants who have been treated with the Allurion™ Gastric Balloon System. The study will include a nested qualitative and quantitative evaluations of the intervention from both the participant and Allurion provider perspective.
The study consists of the following: * Screening and enrolment period (prior to or day of Allurion Gastric Balloon System treatment) * All participants will take part in the Allurion DBCI for 6 months following study enrolment * All participants will complete a 6-month follow-up assessment after completion of the Allurion DBCI
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Allurion Kliniek
Nederland, AB Hilversum, Netherlands
Nederlandse Obesitas Kliniek (NOK)
Amsterdam, Netherlands
Medizen Aesthetic Clinic
Sutton Coldfield, Birmingham, United Kingdom
Monkhouse Surgical
Bromley, Kent, United Kingdom
Start Date
June 19, 2021
Primary Completion Date
May 6, 2022
Completion Date
November 6, 2022
Last Updated
June 1, 2023
107
ACTUAL participants
Allurion Digital Behaviour Change Intervention
DEVICE
Lead Sponsor
Allurion Technologies
NCT07472881
NCT01143454
Data Source & Attribution
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