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

April 21, 2022 updated by: Pentax Medical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105
        • Academic Medical Centre Amsterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
To evaluate safety and treatment effect of the CryoBalloon Ablation System for the Ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy
Device: CryoBalloon Ablation System
Tissue Ablation using CryoBalloon Ablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of CryoBalloon Ablation System
Time Frame: through study completion, an average of 2 weeks
Incidence of device related serious adverse events
through study completion, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Performance
Time Frame: through study completion, an average of 2 weeks
Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction.
through study completion, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pentax Medical

Investigators

  • Principal Investigator: Jacques J.G.H.M. Bergman, MD, PhD, AMC Medical Research B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 24, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CP-0008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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