Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

Esophageal Cancer Clinical Trial

Official title:

Clinical Study to Evaluate the CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729753
• Other study ID #: CP0014
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 30, 2016

Study information

• Verified date: September 2018
• Source: Pentax Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 30, 2016
• Est. primary completion date: October 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Device:
• CryoBalloon™ Full Ablation System
Tissue Ablation using CryoBalloon™ Full Ablation System
• CryoBalloon™ Swipe Ablation System
Tissue Ablation using CryoBalloon™ Swipe Ablation System

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Swedish Medical Center and Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pentax Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the CryoBalloon™ Full and Swipe Ablation System	Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System	2 weeks
Primary	Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems	Evaluated by depth and uniformity of ablation effect in the esophagus based on histopathologic assessment.; Dose response by effect of ablation to submucosa: 0: Normal; Inflammatory cell infiltration; Separation with inflammation; Edema and Necrosis	2 weeks
Secondary	Device Performance: Average Procedure Time	Average Procedure time as measured from start to finish of ablation.	Minutes from start to end of procedure
Secondary	Device Performance: Ease of Deployment of Device	Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)	Minutes, from start to end of procedure