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Allurion Gastric Balloon PAS

29. juni 2026 opdateret af: Allurion Technologies

A Single-Arm, Multi-Center, US-based Study to Obtain Data Regarding the Safety and Effectiveness of the Allurion Gastric Balloon System in the Post-Market Setting

The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary endpoint of the study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS) as obtained in the US pivotal clinical study, TRL-1000-0007. The safety endpoint is the percentage of patients who experience a Serious Adverse Event (SAE) that is device or procedure related.

The secondary endpoint is to evaluate device effectiveness after the sequential balloon therapy.

The effectiveness endpoints are evaluated as:

  1. the percentage of patients with at least 5% Total Body Weight Loss (%TBWL) (responder rate) and
  2. the mean %TBWL at 48 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

250

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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
  • Documented negative pregnancy test in women of childbearing potential
  • Women of childbearing potential not intending to become pregnant for the duration of study participation. (Note: Women of childbearing potential must not be nursing at the time of treatment).
  • Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study
  • At least one unsuccessful attempt at weight loss, such as self-administered, commercial, or medically supervised weight loss program attempted within the 24 months preceding enrollment

Exclusion Criteria:

  • Contra-indications to intragastric balloon placement as outlined in Instructions for Use
  • Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study, or lead to compliance with study requirements, or that might confound study data.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment Arm
All patients eligible to participate will receive the Elipse study device
Enhed: Aktiv Elipse-enhed
Interventionsanordning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Procedure- or Device-Related Serious Adverse Events (SAEs)
Tidsramme: Through 48 weeks (from first balloon placement on Day 0 through end of second balloon therapy period)
Percentage of patients experiencing a procedure- or device-related Serious Adverse Event (Clavien-Dindo Class III or greater) through 48 weeks. The primary objective is to confirm the safety profile of the Allurion Gastric Balloon System (AGBS) in the commercial/post-market setting, consistent with results from the US pivotal study (AUDACITY). All adverse events are coded using MedDRA and classified using the Clavien-Dindo classification system. The endpoint is met if the upper bound of the exact two-sided 95% confidence interval falls below 10%. Analysis is performed on the ITT population (all patients for whom the deployment procedure is attempted).
Through 48 weeks (from first balloon placement on Day 0 through end of second balloon therapy period)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Responder Rate: Percentage of Patients With ≥5% Total Body Weight Loss (%TBWL)
Tidsramme: Week 48
Percentage of patients achieving at least 5% Total Body Weight Loss (%TBWL) at Week 48 (responder rate). %TBWL is calculated as 100 × (Weight on Day 0 - Weight at visit) / Weight on Day 0. This endpoint evaluates device effectiveness following sequential balloon therapy (up to two balloons). Analysis is performed on the modified Intent-to-Treat (mITT) population, defined as all patients who successfully received the Allurion Balloon and for whom the balloon was not known to be removed or exited the body within the first 12 weeks after placement. Responder rate is summarized as a proportion with a 95% two-sided exact confidence interval.
Week 48
Mean Percent Total Body Weight Loss (%TBWL)
Tidsramme: Week 48
Mean Percent Total Body Weight Loss (%TBWL) at Week 48 following sequential balloon therapy (up to two Allurion Balloons placed over the study period). %TBWL is calculated as 100 × (Weight on Day 0 - Weight at visit) / Weight on Day 0. This endpoint evaluates device effectiveness. Analysis is performed on the modified Intent-to-Treat (mITT) population and assessed with a 95% two-sided confidence interval using a mixed model of repeated measures (MMRM) approach.
Week 48

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Allurion Technologies

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

19. februar 2029

Studieafslutning (Anslået)

20. april 2029

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TRL-1000-008
  • PAS001 (Registry Identifier: FDA Post-Approval Studies (PAS) Database)
  • P250023 (Anden identifikator: FDA Premarket Approval (PMA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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