Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy
Launched by PENTAX MEDICAL · Mar 31, 2016
Trial Information
Current as of July 04, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About Pentax Medical
Pentax Medical is a leading global provider of innovative medical technologies and solutions, specializing in the development of advanced endoscopic equipment and devices. Committed to enhancing patient care and improving clinical outcomes, Pentax Medical leverages cutting-edge research and development to deliver high-quality diagnostic and therapeutic tools for healthcare professionals. With a strong focus on collaboration and continuous improvement, the company aims to address the evolving needs of the medical community while ensuring the highest standards of safety and efficacy in its clinical trials and product offerings.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amsterdam, North Holland, Netherlands
Patients applied
Trial Officials
Jacques J.G.H.M. Bergman, MD, PhD
Principal Investigator
AMC Medical Research B.V.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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