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NCT01845454 · ClinicalTrials.gov registry record · NA
A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy
A NA study, sponsored by CSA Medical.
- Terminated
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT01845454: Clinical Trial NA study, sponsored by CSA Medical.
NCT01845454 is a NA study that was terminated before completion, run by CSA Medical. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01845454, a NA study, was terminated before completion, sponsored by CSA Medical.
- TERMINATED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) using trūFreeze™ spray cryotherapy within the currently recommended therapeutic range. Secondary objectives are the determination of safety related outcomes such as esophageal stricture.
Primary Outcome
Percent regression of disease will be used to determine efficacy of spray cryotherapy dose used. If at follow-up there is less than a 50% reduction in Barrett's Esophagus, the outcome will be characterized as sub-therapeutic for that participant. If a 50% or greater reduction is seen then this would be characterized as therapeutic. In each cohort of 15: * If less than 5 subjects are found to have a "therapeutic" response , dose = "ineffective" * If 5 to 10 subjects are found to have a "therapeu
Interventions
- DEVICE trūFreeze™ Spray Cryotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-01 |
| Phase | NA |
Why NCT01845454 stopped before completion
NCT01845454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which trūFreeze™ Spray Cryotherapy is the first listed.
NCT01845454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01845454 about?
NCT01845454 is a clinical study titled "A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy". The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) using trūFreeze™ spray cryotherapy within the currently recommended therapeutic range. Secondary ob...
What is the current status of trial NCT01845454?
This trial is currently terminated. It is a NA study. The enrollment target is 36 participants. The study started on 2013-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01845454?
The interventions under investigation include: trūFreeze™ Spray Cryotherapy (DEVICE).
Who is sponsoring clinical trial NCT01845454?
This trial is sponsored by CSA Medical, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01845454's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 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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