RETHINK REFLUX Registry

Gastroesophageal Reflux Clinical Trial

Official title:

Research to Further Inform Thinking About the Role of LINX for Reflux Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04253392
• Other study ID #: TRX_2018_01
• Status: Active, not recruiting
• Start date: July 8, 2020
• Est. completion date: July 31, 2032

Study information

• Verified date: June 2024
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 31, 2032
• Est. primary completion date: July 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Device:
• LINX Reflux Management System
The LINX Reflux Management System consists of a series of titanium beads each with a magnetic core connected with independent titanium wires to form an annular shape when implanted. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak lower esophageal sphincter (LES) closed. During swallowing, the magnetic beads slide away from each other on the independent titanium wire "links" to allow esophageal distention as the bolus passes by.

Locations

Country	Name	City	State
Austria	MedUni Wien / Universitatsklinik fur Chirurgie	Vienna
Germany	Marien Hospital Herne	Herne
Italy	Univ of Milano / IRCCS Policlinico San Donato	San Donato Milanese
Singapore	National University Hospital	Singapore
United Kingdom	Epsom Hospital	Epsom
United Kingdom	Guy's and St. Thomas' Hospitals	London
United Kingdom	RefluxUK	Tunbridge Wells
United States	Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	Panhandle Weight Loss Center	Amarillo	Texas
United States	Fox Valley Surgical Associates	Appleton	Wisconsin
United States	The Ohio State University	Columbus	Ohio
United States	Saint Elizabeth Healthcare Edgewood	Edgewood	Kentucky
United States	Institute of Esophageal and Reflux Surgery	Englewood	Colorado
United States	East Carolina University / Vidant Medical Center	Greenville	North Carolina
United States	Minimal Access Surgery/Prisma Health - Upstate	Greenville	South Carolina
United States	Adv Surg Assoc / Self Regional Healthcare	Greenwood	South Carolina
United States	Houston Methodist	Houston	Texas
United States	Gen Surg Assoc / Fairfield Medical Center	Lancaster	Ohio
United States	Sparrow Hospital / Sparrow Medical Group	Lansing	Michigan
United States	Keck Hospital of USC	Los Angeles	California
United States	University of South Alabama	Mobile	Alabama
United States	OSF Medical Group	Peoria	Illinois
United States	Richmond Surg / Henrico Doctors' Hospital	Richmond	Virginia
United States	Bariatric Medical Institute of Texas	San Antonio	Texas
United States	Swedish Medical Center	Seattle	Washington
United States	University of Southern Florida (Tampa General Hospital)	Tampa	Florida
United States	NW Allied Bariatric and Foregut Surgery	Tucson	Arizona
United States	Lexington Surgery	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Italy,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Adverse Events	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
Primary	Safety - Explant/Removal	LINX explant/removal	10 years
Primary	Safety - Hiatal Hernia Reoccurrence	Hiatal hernia requiring repair (occurring after the LINX implant)	10 years
Secondary	Effectiveness	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: Percentage of subjects reporting >or=50% reduction in GERD-HRQL scores; 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; Percentage of subjects reporting > or = 50% reduction in average daily proton pump inhibitor (PPI) use	10 years
Secondary	Health Economics - Work Productivity and Activity Impairment	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
Secondary	Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)	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
Secondary	Health Economics - Healthcare Utilization	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