CompletedNot Applicable

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

Netherlands3 participantsStarted 2016-03

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of CryoBalloon Ablation System

Timeframe: through study completion, an average of 2 weeks

Trial details

NCT IDNCT02729727

SponsorPentax Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06-24

View on ClinicalTrials.gov More Esophageal Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.