Allurion_TRL-1000-0007_AUDACITY

Summary

Co-Primary Effectiveness Endpoint 1: Responder Rate (RR) dichotomized at 5% TBWL at 48 weeks is significantly greater than 50%. Co-Primary Effectiveness Endpoint 2: Treatment Group mean %TBWL is significantly greater than Control Group mean %TBWL at 48 weeks, with a super superiority margin of 3.0%. The primary safety endpoint of this clinical investigation is the overall incidence of procedure- or device-related Serious Adverse Events through 48 weeks.


Inclusion Criteria

  • Age ≥22 years and ≤ 65 years of age
  • BMI ≥30 kg/m2 and ≤ 40 kg/m2
  • Have signed study specific Informed Consent Form
  • Willing to comply with study requirements, including follow-up visits
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A Prospective, Open-Label, Multi-Center, Randomized, Pivotal Safety and Efficacy Study of the Allurion Gastric Balloon System + Moderate Intensity Lifestyle Modification Therapy Program vs. Moderate Intensity Lifestyle Modification Therapy Program for the Treatment of Adults with Obesity A Prospective, Open-Lbl, Multi-Ctr, Random, Pivotal Safety & Efficacy Study of Allurion Gastric Balloon Sys + Mod Intensity Lifestyle Modification Therapy vs Mod Intensity Lifestyle Modification Therapy for Treatment of Adults w/Obesity

Details
Disease Type/Condition

Obesity

Principal Investigator

Watson, Rabindra

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002046

ClinicalTrials.gov ID

NCT05368259

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Obesity

Principal Investigator

Watson, Rabindra

Age Group

Adult

Phase

N/A

IRB Number

TRL-1000-0007

ClinicalTrials.gov ID

NCT05368259

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?