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Observational Study of Anti-Reflux Surgery

Sponsor
Torax Medical Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01624506
Collaborator
(none)
760
Enrollment
21
Locations
101.9
Duration (Months)
36.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Anti-Reflux Surgical Study has been established to:

  • Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice

  • Track the clinical course of patients from pre-operative assessment to three years post-surgery

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will track and monitor patients treated with either the magnetic sphincter augmentation or Fundoplication, making it the first Registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    760 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication
    Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2015
    Actual Study Completion Date :
    Jul 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Magnetic Sphincter Augmentation

    Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
    Fundoplication

    Patients treated with laparoscopic fundoplication

    Outcome Measures

    Primary Outcome Measures

    1. Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) [3 years post-surgery]

      Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Individuals treated with LINX Reflux Management System or Fundoplication

    • Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the Anti-Reflux Surgical Registry.

    • Individuals willing to complete questionnaires and comply with the three years of follow-up.

    Exclusion Criteria:
    • Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy <3 years)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herz Jesu Krankenhaus Vienna Austria
    2 AKH Wien Wien Austria
    3 MIC Klinik Berlin Berlin Germany
    4 Knappschafts Krankenhaus Bottrop Bottrop Germany
    5 Diako Bremen Bremen Germany
    6 Krankenhaus Castrop Rauxel Castrop Rauxel Germany
    7 Klinikum Forchheim Forchheim Germany
    8 Krankenhaus Herne Herne Germany
    9 Marien Krankenhaus Kassel Germany
    10 Uniklinikum Koln Koln Germany
    11 Arabella Klinik Munchen Germany
    12 Ruppiner Kliniken Neuruppin Germany
    13 Stadtkrankenhaus Schwabach Schwabach Germany
    14 St. Rochus Telgte Germany
    15 Ev. K Zweibrucken Zweibrucken Germany
    16 Policlinico San Donato Milan Italy
    17 Reflux Centre Birmingham United Kingdom
    18 Epsom and St. Helier Hospital Epsom United Kingdom
    19 Royal Devon & Exeter Hospital Exeter United Kingdom
    20 Spire Tunbridge Wells Hospital Tunbridge Wells United Kingdom
    21 Weymouth Hospital Weymouth United Kingdom

    Sponsors and Collaborators

    • Torax Medical Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Torax Medical Incorporated
    ClinicalTrials.gov Identifier:
    NCT01624506
    Other Study ID Numbers:
    • 2776
    First Posted:
    Jun 20, 2012
    Last Update Posted:
    Jun 8, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Torax Medical Incorporated
    Gastroesophageal Reflux Disease
    Fundoplication
    Magnetic Sphincter Augmentation
    Proton Pump Inhibitors
    GERD
    PPI
    MSA
    Additional relevant MeSH terms:
    Gastroesophageal Reflux

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Not required
    Arm/Group Title Magnetic Sphincter Augmentation Fundoplication
    Arm/Group Description Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System Patients treated with laparoscopic fundoplication
    Period Title: Overall Study
    STARTED 530 230
    COMPLETED 465 213
    NOT COMPLETED 65 17

    Baseline Characteristics

    Arm/Group Title Magnetic Sphincter Augmentation Fundoplication Total
    Arm/Group Description Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System Patients treated with laparoscopic fundoplication Total of all reporting groups
    Overall Participants 530 230 760
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.8
    (13.7)
    55.8
    (12.1)
    49.4
    (13.9)
    Sex: Female, Male (Count of Participants)
    Female
    198
    37.4%
    113
    49.1%
    311
    40.9%
    Male
    321
    60.6%
    102
    44.3%
    423
    55.7%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    Austria
    27
    5.1%
    34
    14.8%
    61
    8%
    Italy
    104
    19.6%
    37
    16.1%
    141
    18.6%
    United Kingdom
    101
    19.1%
    26
    11.3%
    127
    16.7%
    Germany
    298
    56.2%
    133
    57.8%
    431
    56.7%
    Years with Gastroesophageal Reflux Disease (GERD) (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    9.0
    (7.9)
    8.9
    (8.1)
    9.0
    (7.9)
    Years with Proton Pump Inhibitors (PPI) (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    6.1
    (5.4)
    5.8
    (5.7)
    6.0
    (5.5)

    Outcome Measures

    1. Primary Outcome
    Title Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)
    Description Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse
    Time Frame 3 years post-surgery

    Outcome Measure Data

    Analysis Population Description
    Enrolled subjects who completed the 3-year visit and responded to the Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) questionnaire are included in the analysis.
    Arm/Group Title Magnetic Sphincter Augmentation Fundoplication
    Arm/Group Description Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System Patients treated with laparoscopic fundoplication
    Measure Participants 328 97
    Mean (Standard Deviation) [score on a scale]
    4.2
    (5.7)
    4.9
    (7.8)

    Adverse Events

    Time Frame 3 years
    Adverse Event Reporting Description
    Arm/Group Title Magnetic Sphincter Augmentation Fundoplication
    Arm/Group Description Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System Patients treated with laparoscopic fundoplication
    All Cause Mortality
    Magnetic Sphincter Augmentation Fundoplication
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/530 (0.2%) 0/230 (0%)
    Serious Adverse Events
    Magnetic Sphincter Augmentation Fundoplication
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 22/530 (4.2%) 4/230 (1.7%)
    Gastrointestinal disorders
    Dysphagia 10/530 (1.9%) 11 0/230 (0%) 0
    Gatric pain 2/530 (0.4%) 2 0/230 (0%) 0
    Gastritis 0/530 (0%) 0 1/230 (0.4%) 1
    Heartburn 3/530 (0.6%) 3 0/230 (0%) 0
    Worsening of GERD 6/530 (1.1%) 6 1/230 (0.4%) 1
    Injury, poisoning and procedural complications
    Device erosion 1/530 (0.2%) 1 0/230 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia 0/530 (0%) 0 1/230 (0.4%) 1
    Vascular disorders
    Hypertension 0/530 (0%) 0 1/230 (0.4%) 1
    Other (Not Including Serious) Adverse Events
    Magnetic Sphincter Augmentation Fundoplication
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 98/530 (18.5%) 30/230 (13%)
    Gastrointestinal disorders
    Heartburn 52/530 (9.8%) 61 14/230 (6.1%) 15
    Dysphagia 49/530 (9.2%) 54 16/230 (7%) 18

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Janet DeMarchi
    Organization Ethicon
    Phone 612-867-8727
    Email jdemarch@its.jnj.com
    Responsible Party:
    Torax Medical Incorporated
    ClinicalTrials.gov Identifier:
    NCT01624506
    Other Study ID Numbers:
    • 2776
    First Posted:
    Jun 20, 2012
    Last Update Posted:
    Jun 8, 2021
    Last Verified:
    May 1, 2021