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NCT01940185

A Post-Approval Study of the LINX® Reflux Management System

Completed Last updated 5 January 2024
What this trial tests

trial testing LINX device in Gastroesophageal Reflux Disease (GERD) in 200 participants. Completed in 30 June 2023.

Timeline
30 June 2012
Primary endpoint
30 June 2023
30 June 2023

Quick facts

Lead sponsorTorax Medical Incorporated
StatusCompleted
Study typeOBSERVATIONAL
Enrollment200
Start date30 June 2012
Primary completion30 June 2023
Estimated completion30 June 2023
Sites19 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Torax Medical Incorporated

Who can join

21 and older, any sex, with Gastroesophageal Reflux Disease (GERD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Long-term cost-effectiveness of medical, endoscopic and surgical management of gastroesophageal reflux disease.
    Funk LM, Zhang JY, Drosdeck JM, Melvin WS, et al · · 2015 · cited 32× · PMID 25262216 · DOI 10.1016/j.surg.2014.05.027
  2. Long-term (>5 Years) Outcomes after Magnetic Sphincter Augmentation.
    Louie BE, Woldu HG, Bell RCW, Perry KA, et al · · 2026 · PMID 42117783 · DOI 10.1097/sla.0000000000006591

Verify or expand the search:

Other trials of LINX device

Trials testing the same drug.

Other recruiting trials for Gastroesophageal Reflux Disease (GERD)

Currently open trials in the same condition.

Other Torax Medical Incorporated trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01940185.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing