N/A
Completed N=10
Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium
Source: ClinicalTrials.gov NCT02729753 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Safety of the CryoBalloon™ Full and Swipe Ablation System — 0; 0 Participants
Summary
This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of the CryoBalloon™ Full and Swipe Ablation System |
0; 0 | — |
| PRIMARY Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems |
2; 0; 3; 1; 1; 2 | — |
| SECONDARY Device Performance: Average Procedure Time |
5; 4.8 | — |
| SECONDARY Device Performance: Ease of Deployment of Device |
9; 7.8 | — |
Eligibility Criteria
Inclusion Criteria
- Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation
- Older than 18 years of age
- Requires a clinically necessary esophagectomy for esophageal cancer or other indications.
Exclusion Criteria
- Patient has esophageal narrowing limiting access to the intended sites of ablation
Data sourced from ClinicalTrials.gov (NCT02729753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.