Clinical trial NCT04253392: RETHINK REFLUX Registry
Official title: Research to Further Inform Thinking About the Role of LINX for Reflux Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux Disease
GERD
Reflux
Regurgitation
Esophageal Disease
Lower Esophageal Sphincter
LES
Magnetic Sphincter Augmentation
MSA
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety - Adverse Events
timeFrame: 10 years
measure: Safety - Explant/Removal
timeFrame: 10 years
measure: Safety - Hiatal Hernia Reoccurrence
timeFrame: 10 years
Secondary outcomes:
measure: Effectiveness
timeFrame: 10 years
measure: Health Economics - Work Productivity and Activity Impairment
timeFrame: 10 years
measure: Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)
timeFrame: Baseline
measure: Health Economics - Healthcare Utilization
timeFrame: 10 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Tucson
country: United States
facility: NW Allied Bariatric and Foregut Surgery
state: Arizona
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Englewood
country: United States
facility: Institute of Esophageal and Reflux Surgery
state: Colorado
city: Tampa
country: United States
facility: University of Southern Florida (Tampa General Hospital)
state: Florida
city: Peoria
country: United States
facility: OSF Medical Group
state: Illinois
city: Edgewood
country: United States
facility: Saint Elizabeth Healthcare Edgewood
state: Kentucky
city: Lansing
country: United States
facility: Sparrow Hospital / Sparrow Medical Group
state: Michigan
city: Greenville
country: United States
facility: East Carolina University / Vidant Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Lancaster
country: United States
facility: Gen Surg Assoc / Fairfield Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital - Cedar Crest
state: Pennsylvania
city: Greenville
country: United States
facility: Minimal Access Surgery/Prisma Health - Upstate
state: South Carolina
city: Greenwood
country: United States
facility: Adv Surg Assoc / Self Regional Healthcare
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Surgery
state: South Carolina
city: Amarillo
country: United States
facility: Panhandle Weight Loss Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: San Antonio
country: United States
facility: Bariatric Medical Institute of Texas
state: Texas
city: Richmond
country: United States
facility: Richmond Surg / Henrico Doctors' Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Appleton
country: United States
facility: Fox Valley Surgical Associates
state: Wisconsin
city: Vienna
country: Austria
facility: MedUni Wien / Universitatsklinik fur Chirurgie
city: Herne
country: Germany
facility: Marien Hospital Herne
city: San Donato Milanese
country: Italy
facility: Univ of Milano / IRCCS Policlinico San Donato
city: Singapore
country: Singapore
facility: National University Hospital
city: Epsom
country: United Kingdom
facility: Epsom Hospital
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospitals
city: Tunbridge Wells
country: United Kingdom
facility: RefluxUK
Study officials:
affiliation: Ethicon Endo-Surgery
name: Jörg Tomaszewski, MD
role: STUDY_DIRECTOR
References: