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NCT04770441 · ClinicalTrials.gov registry record
Transoral Incisionless Fundoplication in Post-POEM GERD
A clinical trial, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- 7
- Enrollment target
NCT04770441: Completed study, sponsored by Baylor College of Medicine.
NCT04770441 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04770441 has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- 7 participants
- Enrollment target
Study Summary
POEM (per oral endoscopic myotomy) is effective for the treatment of swallowing disorders but can induce acid reflux. If acid reflux remains untreated in this situation, it can lead to significant problems. Thus, minimizing abnormal acid exposure after POEM is very important. Typically, this is done with acid suppression medications such as Prilosec or Nexium. However, long term acid suppression medication has been linked to possible long-term complications. Transoral incisionless fundoplication (TIF) has been approved for the treatment of reflux, but its use in reflux after POEM has not been investigated in detail. We hypothesize TIF will be able to decrease the amount of acid reflux in to the esophagus, thereby allowing patients to remain off of acid suppression medications. Once enrolled into the study, you will undergo the POEM procedure. 3 months after the procedure we will assess for abnormal reflux via questionnaires and diagnostic testing as part of the standard management post POEM. If there is evidence of abnormal reflux, the TIF procedure will be performed. 3 months after the TIF, you will have similar testing again to document resolution in abnormal acid reflux.You will be followed for 12 months as part of the study. If at the 3 month mark, there is no evidence of abnormal reflux, you will neither be placed on PPI nor undergo TIF and will be followed for 12 months to assess for abnormal reflux
Primary Outcome
If at least 50% of patients do not require initiation of PPI therapy at the end of the study, then TIF would be considered successful.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2023-06-03 |
What the finished NCT04770441 record still lists
NCT04770441 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04770441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04770441 about?
NCT04770441 is a clinical study titled "Transoral Incisionless Fundoplication in Post-POEM GERD". POEM (per oral endoscopic myotomy) is effective for the treatment of swallowing disorders but can induce acid reflux. If acid reflux remains untreated in this situation, it can lead to significant problems. Thus, minimizing abnormal acid exposure after POEM is very important. Typically, this is done...
What is the current status of trial NCT04770441?
This trial is currently completed. The enrollment target is 7 participants. The study started on 2021-03-17. Estimated completion is 2023-06-03.
Who is sponsoring clinical trial NCT04770441?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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