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Completed

NCT Number: NCT02729727

Clinical Study to Evaluate CryoBalloon™ Ablation System 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

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Centre Amsterdam

Amsterdam, North Holland, 1105, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cryoballoon ablation system

Device

Tissue Ablation using CryoBalloon Ablation System

Primary outcomes

  1. Safety of CryoBalloon Ablation System

    Time frame: through study completion, an average of 2 weeks

    Incidence of device related serious adverse events

Secondary outcomes

  1. Device Performance

    Time frame: through study completion, an average of 2 weeks

    Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction.

Sponsors and collaborators

Lead sponsor

Pentax Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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