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NCT01582100 · ClinicalTrials.gov registry record · NA
Reletex for Nausea in GERD Patients
A NA study, sponsored by Northwestern University.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT01582100: Clinical Trial NA study, sponsored by Northwestern University.
NCT01582100 is a NA study that was terminated before completion, run by Northwestern University. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01582100, a NA study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
Gastroesophageal reflux disease (GERD) is a highly prevalent condition that is frequently encountered in the health care setting. It affects roughly 40% of Americans monthly and 10% weekly. Of those with GERD, there exists a cohort that experience nausea with or without vomiting that is unresponsive to PPI's and anti-emetics. For these patients, treatment options are limited and these symptoms may substantially alter their quality of life. New and novel therapies emerging include neuromodulation devices that may affect the central pathways leading to these symptoms. Of these, the Reletex band has been tested and proven efficacious in the treatment of nausea and vomiting associated with pregnancy, chemotherapy, and surgery, in addition to standard anti-nausea medications. The investigators propose that through a similar mechanism, this device as an adjunct to PPI's and anti-emetics will reduce GERD-associated the nausea with or without vomiting, and by so doing, improve the quality of lives in this patient population.
Primary Outcome
number of events of nausea with or without vomiting in patients with GERD in 4 weeks
Interventions
- DEVICE Reletex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-11 |
| Phase | NA |
Why NCT01582100 stopped before completion
NCT01582100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Reletex is the first listed.
NCT01582100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01582100 about?
NCT01582100 is a clinical study titled "Reletex for Nausea in GERD Patients". Gastroesophageal reflux disease (GERD) is a highly prevalent condition that is frequently encountered in the health care setting. It affects roughly 40% of Americans monthly and 10% weekly. Of those with GERD, there exists a cohort that experience nausea with or without vomiting that is unresponsive...
What is the current status of trial NCT01582100?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2012-03. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01582100?
The interventions under investigation include: Reletex (DEVICE).
Who is sponsoring clinical trial NCT01582100?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01582100's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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