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NCT03621319 · ClinicalTrials.gov registry record · NA
Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique
A NA study, sponsored by Erbe Elektromedizin.
- Terminated
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT03621319 is a NA study that was terminated before completion, run by Erbe Elektromedizin. The registered enrollment target is 41 participants.
The verdict
NCT03621319, a NA study, was terminated before completion, sponsored by Erbe Elektromedizin.
- TERMINATED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study Summary
Lay summary: Barrett's Esophagus (BE) involves a change of the esophagus lining (BE epithelium) which in a small proportion of patients could be the starting point for the development of cancer (esophageal adenocarcinoma). Currently, there is evidence that this change is initiated by acid reflux from the stomach which then could progress in a stepwise manner from the healthy epithelium to cellular changes (intestinal metaplasia, low-grade and high-grade dysplasia) and finally to adenocarcinoma. Surgery is considered the standard therapy for this cancer which involves the risk of death and complications with quality of life impairments. New possibilities for treatment have evolved with endoscopic therapies which allow for treatment of early changes of the epithelium (intestinal metaplasia and dysplasia) prior to the occurrence of cancer using either argon plasma coagulation (APC) or radiofrequency ablation (RFA). Both are established methods for eradication of BE by thermal ablation of the BE epithelium using high frequency current (HF). More advanced BE epithelium with early visible cancers are being treated by endoscopic mucosal resection (EMR). After EMR the residual Barrett's epithelium can also be removed by ablation with RFA or APC. Currently radiofrequency ablation (RFA) has been suggested as the standard therapy for BE treatment. Although effective in the eradication of the BE epithelium after RFA treatment the re-appearance of BE epithelium and the occurrence of complications such as strictures causing swallowing impairments for food have also been observed in clinical studies. A recently developed method is Hybrid argon plasma coagulation (ablation) \[HybridAPC® (HAPC)\] which combines argon plasma coagulation (APC) with a fluid injection function by a water beam. The water beam allows to establish a fluid cushion (normal sterile saline) right beneath the BE-epithelium prior to thermal ablation thereby protecting the esophagus wall from heat during ablation
Interventions
- DEVICE Radiofrequency ablation (RFA)
- DEVICE Hybrid argon plasma ablation (HAPC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-07-24 |
| Est. Completion | 2021-05-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03621319
The ClinicalTrials.gov registry entry for NCT03621319 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Erbe Elektromedizin, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Radiofrequency ablation (RFA) is the first listed.
NCT03621319 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03621319 about?
NCT03621319 is a clinical study titled "Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique". Lay summary: Barrett's Esophagus (BE) involves a change of the esophagus lining (BE epithelium) which in a small proportion of patients could be the starting point for the development of cancer (esophageal adenocarcinoma). Currently, there is evidence that this change is initiated by acid reflux fro...
What is the current status of trial NCT03621319?
This trial is currently terminated. It is a NA study. The enrollment target is 41 participants. The study started on 2019-07-24. Estimated completion is 2021-05-05.
What interventions are being tested in trial NCT03621319?
The interventions under investigation include: Radiofrequency ablation (RFA) (DEVICE), Hybrid argon plasma ablation (HAPC) (DEVICE).
Who is sponsoring clinical trial NCT03621319?
This trial is sponsored by Erbe Elektromedizin, which has 2 total clinical trials registered on ClinicalTrials.gov.
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