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RETHINK REFLUX Registry

2. november 2026 opdateret af: Ethicon Endo-Surgery

Forskning for yderligere at informere tænkning om LINX's rolle for reflukssygdom

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

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

21 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: CASE_ONLY
  • Tidsperspektiver: PROSPECTIVE

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Ethicon Endo-Surgery

Efterforskere

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

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 (Faktiske)

8. juli 2020

Primær færdiggørelse (Anslået)

31. juli 2032

Studieafslutning (Anslået)

31. juli 2032

Datoer for studieregistrering

Først indsendt

31. januar 2020

Først indsendt, der opfyldte QC-kriterier

31. januar 2020

Først opslået (Faktiske)

5. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TRX_2018_01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

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.

Ja

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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