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The Allurion Digital Behaviour Change Intervention

NCT05884606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2023-06-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Allurion Digital Behaviour Change Intervention

The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity.

Sponsors & Collaborators

  • Allurion Technologies

    lead INDUSTRY

Principal Investigators

  • Paul Sacher, RD, PhD · Director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-19
Primary Completion
2022-05-06
Completion
2022-11-06
FDA Device
Yes

Countries

  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05884606 on ClinicalTrials.gov