Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy

Esophageal Cancer Clinical Trial

Official title:

Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729727
• Other study ID #: CP-0008
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: June 30, 2016

Study information

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

Clinical Trial Summary

To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 30, 2016
• Est. primary completion date: June 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation

• Older than 18 years of age at the time of consent

• Requires a clinically-necessary esophagectomy for esophageal cancer

• Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC)

Exclusion Criteria:

• Patient refuses or is unable to provide written informed consent

• Patient has esophageal narrowing limiting access to the intended site of ablation

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Device:
• CryoBalloon Ablation System
Tissue Ablation using CryoBalloon Ablation System

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre Amsterdam	Amsterdam	North Holland

Sponsors (1)

Lead Sponsor	Collaborator
Pentax Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of CryoBalloon Ablation System	Incidence of device related serious adverse events	through study completion, an average of 2 weeks
Secondary	Device Performance	Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction.	through study completion, an average of 2 weeks