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NCT02211105 · ClinicalTrials.gov registry record

Registry to Compare Two Surgical Treatments for GERD

A clinical trial, sponsored by American Gastroenterological Association.

Terminated
Registry status
46
Enrollment target

NCT02211105: Clinical Trial study, sponsored by American Gastroenterological Association.

NCT02211105 is a clinical trial that was terminated before completion, run by American Gastroenterological Association. The registered enrollment target is 46 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02211105 was terminated before completion, sponsored by American Gastroenterological Association.

TERMINATED
Registry status
46 participants
Enrollment target

Study Summary

The purpose of this prospective observational research study registry is to examine whether two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side effects and post-procedure costs associated with episodes of care and any ensuing complications.

Primary Outcome

To compare the effectiveness of TIF and LNF at the end of three years compared to baseline using a 75% reduction in GERD Health-related Quality of Life (GERD-HRQL) as a threshold for effectiveness.

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2014-07
Est. Completion 2017-04

Why NCT02211105 stopped before completion

NCT02211105 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 46 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02211105 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02211105 about?

NCT02211105 is a clinical study titled "Registry to Compare Two Surgical Treatments for GERD". The purpose of this prospective observational research study registry is to examine whether two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side effects and post-procedure cost...

What is the current status of trial NCT02211105?

This trial is currently terminated. The enrollment target is 46 participants. The study started on 2014-07. Estimated completion is 2017-04.

Who is sponsoring clinical trial NCT02211105?

This trial is sponsored by American Gastroenterological Association, which has 3 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02211105, the US trial registry maintained by the National Library of Medicine. NCT02211105 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.