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NCT03387982 · ClinicalTrials.gov registry record
Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study
A clinical trial, sponsored by Geisinger Clinic.
- Completed
- Registry status
- 95
- Enrollment target
NCT03387982: Completed study, sponsored by Geisinger Clinic.
NCT03387982 is a clinical trial that has completed, run by Geisinger Clinic. The registered enrollment target is 95 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03387982 has completed, sponsored by Geisinger Clinic.
- COMPLETED
- Registry status
- 95 participants
- Enrollment target
Study Summary
Barrett's esophagus is a condition in which the normal lining of the lower esophagus is replaced with cells that predispose an individual to development of esophageal cancer. Treatment of Barrett's esophagus reduces the risk of progression to cancer. Treatment is provided endoscopically, via a variety of approved techniques including endoscopic mucosal resection, argon plasma coagulation, radiofrequency ablation (RFA), spray cryotherapy ablation and balloon cryotherapy ablation. A common side effect of ablation treatment is pain, thus making pain an important factor when discussing treatment options. It is speculated that balloon cryotherapy causes less pain than RFA but no head-to-head comparison trials exist to date. This multi-center, prospective cohort study aims to compare pre- and post-procedural pain for balloon cryotherapy versus RFA. Providing both patients and clinicians with data from a well-designed prospective study may help guide future physician/patient treatment discussions.
Primary Outcome
Differences in PQAS scores between groups will be determined by using the t test or Wilcoxon test for continuous variables and the Fisher exact test for categorical variables. The Pain Quality Assessment Scale (PQAS) assesses distinct pain qualities associated with all types and categories of pain problems. The PQAS is a 20-item measure used to assess pain qualities associated with non-neuropathic pain. The PQAS asks respondents to rate the severity of each of 20 pain (quality and spatial) descr
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2021-02-16 |
What the finished NCT03387982 record still lists
NCT03387982 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 95 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03387982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03387982 about?
NCT03387982 is a clinical study titled "Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study". Barrett's esophagus is a condition in which the normal lining of the lower esophagus is replaced with cells that predispose an individual to development of esophageal cancer. Treatment of Barrett's esophagus reduces the risk of progression to cancer. Treatment is provided endoscopically, via a varie...
What is the current status of trial NCT03387982?
This trial is currently completed. The enrollment target is 95 participants. The study started on 2017-11-01. Estimated completion is 2021-02-16.
Who is sponsoring clinical trial NCT03387982?
This trial is sponsored by Geisinger Clinic, which has 107 total clinical trials registered on ClinicalTrials.gov.
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