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Allurion Gastric Balloon PAS

29. juni 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

250

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment Arm
All patients eligible to participate will receive the Elipse study device
Enhet: Aktiv Elipse-enhet
Intervensjonsenhet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Allurion Technologies

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juli 2026

Primær fullføring (Antatt)

19. februar 2029

Studiet fullført (Antatt)

20. april 2029

Datoer for studieregistrering

Først innsendt

29. juni 2026

Først innsendt som oppfylte QC-kriteriene

29. juni 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TRL-1000-008
  • PAS001 (Registeridentifikator: FDA Post-Approval Studies (PAS) Database)
  • P250023 (Annen identifikator: FDA Premarket Approval (PMA))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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