At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 7 enrolled
Drug / intervention
Cryo Spray Ablation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A STUDY OF CRYOSPRAY ABLATIONTM USING SURGICAL RESECTION SPECIMENS TO DETERMINE TREATMENT EFFECT, DEPTH OF INJURY, AND SIDE EFFECTS IN THE ESOPHAGUS (CSA Depth 3)
In Brief
A Phase 4 clinical trial evaluating Cryo Spray Ablation for Barrett's Esophagus and Esophageal Cancer. Completed, enrolled 7 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBarrett's Esophagus, Esophageal Cancer
CountriesUnited States
CollaboratorsUniversity of Miami
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartFeb 2009
Primary CompletionMar 2012
TodayJul 2026
First PostedSep 18, 2008
Enrollment StartFeb 1, 2009
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.8 years ago
Interventions
Cryo Spray Ablationdevice
Cryo Spray Ablation 4 cycles x 10 seconds treatment
Cryo Spray Ablationdevice
Cryo Spray Ablation 2 cycles x 20 seconds