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NCT Number: NCT02729753

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

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

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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

MD Anderson Cancer Center, Houston, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CryoBalloon™ Full Ablation System

Device

Tissue Ablation using CryoBalloon™ Full Ablation System

Other names: CryoBalloon Ablation System (360)

CryoBalloon™ Swipe Ablation System

Device

Tissue Ablation using CryoBalloon™ Swipe Ablation System

Other names: CryoBalloon Ablation System (90)

Primary outcomes

  1. Safety of the CryoBalloon™ Full and Swipe Ablation System

    Time frame: 2 weeks

    Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System

  2. Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems

    Time frame: 2 weeks

    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

Secondary outcomes

  1. Device Performance: Average Procedure Time

    Time frame: Minutes from start to end of procedure

    Average Procedure time as measured from start to finish of ablation.

  2. Device Performance: Ease of Deployment of Device

    Time frame: Minutes, from start to end of procedure

    Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)

Sponsors and collaborators

Lead sponsor

Pentax Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Apr 22, 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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