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RETENK REFLUX-registeret

2. november 2026 oppdatert av: Ethicon Endo-Surgery

Forskning for ytterligere å informere tenkning om rollen til LINX for reflukssykdom

The RETHINK REFLUX Registry is a post-market prospective, multi-center, observation, single arm, long-term safety surveillance registry of subjects implanted with the LINX device. The primary objective of the study is to confirm the long-term safety profile of the LINX device and procedure (implant/explant) up to 10 years post-implant.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The RETHINK REFLUX Registry or Research to further inform thinking about the role of LINX for Reflux Disease is sponsored by Ethicon Endo-Surgery, Inc. This is a post-market prospective, multi-center, observational, single arm, long-term safety surveillance registry of subjects implanted with the LINX device. Up to 500 subjects will be enrolled and implanted at up to 50 centers in both the US and selected countries outside the US with regulatory approval for the LINX Reflux Management System. The study will collect data from patients 10 years post implant. The primary objective of the study is to confirm the long-term safety profile of the LINX device and procedure (implant/explant). Secondary objectives include Effectiveness, Health Economics and Health Utilization.

Studietype

Observasjonsmessig

Registrering (Faktiske)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Mobile, Alabama, Forente stater, 36617
        • University of South Alabama
    • Arizona
      • Tucson, Arizona, Forente stater, 85741
        • NW Allied Bariatric and Foregut Surgery
    • California
      • Los Angeles, California, Forente stater, 90033
        • Keck Hospital of USC
    • Colorado
      • Englewood, Colorado, Forente stater, 80113
        • Institute of Esophageal and Reflux Surgery
    • Florida
      • Tampa, Florida, Forente stater, 33606
        • University of Southern Florida (Tampa General Hospital)
    • Illinois
      • Peoria, Illinois, Forente stater, 61615
        • OSF Medical Group
    • Kentucky
      • Edgewood, Kentucky, Forente stater, 41017
        • Saint Elizabeth Healthcare Edgewood
    • Michigan
      • Lansing, Michigan, Forente stater, 48912
        • Sparrow Hospital / Sparrow Medical Group
    • North Carolina
      • Greenville, North Carolina, Forente stater, 27834
        • East Carolina University / Vidant Medical Center
    • Ohio
      • Columbus, Ohio, Forente stater, 43210
        • The Ohio State University
      • Lancaster, Ohio, Forente stater, 43130
        • Gen Surg Assoc / Fairfield Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18102
        • Lehigh Valley Hospital - Cedar Crest
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29607
        • Minimal Access Surgery/Prisma Health - Upstate
      • Greenwood, South Carolina, Forente stater, 29646
        • Adv Surg Assoc / Self Regional Healthcare
      • West Columbia, South Carolina, Forente stater, 29169
        • Lexington Surgery
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Panhandle Weight Loss Center
      • Houston, Texas, Forente stater, 77030
        • Houston Methodist
      • San Antonio, Texas, Forente stater, 78258
        • Bariatric Medical Institute of Texas
    • Virginia
      • Richmond, Virginia, Forente stater, 23229
        • Richmond Surg / Henrico Doctors' Hospital
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Swedish Medical Center
    • Wisconsin
      • Appleton, Wisconsin, Forente stater, 54911
        • Fox Valley Surgical Associates
  • Italia
      • San Donato Milanese, Italia, 20097
        • Univ of Milano / IRCCS Policlinico San Donato
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital
  • Storbritannia
      • Epsom, Storbritannia, KT18 7EG
        • Epsom Hospital
      • London, Storbritannia, SE1 7EH
        • Guy's and St. Thomas' Hospitals
      • Royal Tunbridge Wells, Storbritannia, TN3 0RD
        • RefluxUK
  • Tyskland
      • Herne, Tyskland, 44625
        • Marien Hospital Herne
  • Østerrike
      • Vienna, Østerrike, 1090
        • MedUni Wien / Universitatsklinik fur Chirurgie

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

21 år til 99 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients successfully implanted (treated) with the LINX Reflux Management System for the treatment of GERD (Implant success defined as leaving the surgical suite with a device in situ)

Beskrivelse

Inclusion Criteria:

  1. Subject is >or=21 years old
  2. Subject with prospective plans for a LINX procedure
  3. Subject provides written informed consent
  4. Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)

Exclusion Criteria:

  1. Subject who was previously implanted with LINX device
  2. Any reason which the Principal Investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements (i.e. medical illness and/or limited life expectancy of less than 10 years)

Note: Physicians should refer to the LINX Reflux Management System IFU for a complete list of contraindications, warnings, and precautions.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: CASE_ONLY
  • Tidsperspektiver: PROSPECTIVE

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety - Adverse Events
Tidsramme: 10 years

Adverse events related to the LINX device and/or procedure (implant/explant) limited to:

  • All related serious adverse events
  • All related adverse events of dysphagia and or odynophagia requiring treatment (only)
  • LINX migration
  • LINX erosion
10 years
Safety - Explant/Removal
Tidsramme: 10 years

LINX explant/removal
10 years
Safety - Hiatal Hernia Reoccurrence
Tidsramme: 10 years

Hiatal hernia requiring repair (occurring after the LINX implant)
10 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effectiveness
Tidsramme: 10 years

Follow-up questionnaires Gastroesophageal Reflux Disease Esophageal Health Related Quality of Life Questionnaire (GERD-HRQL), Foregut Symptoms Questionnaire (FSQ) and GERD Medication Survey] will be collected and compared to baseline with evaluation to include:

  1. Percentage of subjects reporting >or=50% reduction in GERD-HRQL scores

  2. Percentage of subjects reporting the following on the FSQ:

    • Elimination of moderate or severe regurgitation
    • Reduction in extra-esophageal symptoms
    • Maintain the ability to belch
    • Maintain the ability to vomit

  3. Percentage of subjects reporting > or = 50% reduction in average daily proton pump inhibitor (PPI) use
10 years
Health Economics - Work Productivity and Activity Impairment
Tidsramme: 10 years

Measure of the impact of GERD on a subject's ability to work will be collected through the responses on the Work Productivity and Activity Impairment (WPAI) questionnaire. Percentages of impairment at baseline will be compared to scores collected annually. Four types of scores will be analyzed:

  • Absenteeism (work time missed)
  • Presenteeism (impairment of work/ reduced on-the-job effectiveness)
  • Work productivity loss (overall work impairment/ absenteeism plus presenteeism)
  • Activity impairment
10 years
Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)
Tidsramme: Baseline

To better understand a subject's process for making GERD related healthcare decisions and his/her care pathways, the LINX Interest Survey will be collected once at baseline, prior the implant procedure
Baseline
Health Economics - Healthcare Utilization
Tidsramme: 10 years

Analysis of healthcare economics in subjects who seek treatment for worsening of GERD symptoms and device/procedural complications over 10 years. A Healthcare Encounter Survey will be completed by subjects.
10 years

Samarbeidspartnere og etterforskere

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

Sponsor

Ethicon Endo-Surgery

Etterforskere

  • Studieleder: Jeffery Lowell, MD, Ethicon Endo-Surgery

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 (Faktiske)

8. juli 2020

Primær fullføring (Antatt)

31. juli 2032

Studiet fullført (Antatt)

31. juli 2032

Datoer for studieregistrering

Først innsendt

31. januar 2020

Først innsendt som oppfylte QC-kriteriene

31. januar 2020

Først lagt ut (Faktiske)

5. februar 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TRX_2018_01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

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

Ja

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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