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Irreversible Electroporation for Enlargement

Not yet recruiting at 1 trial location
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: ENTire Medical Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a prospective, multi-center, single-arm study of pediatric subjects (age 3-12) with Sleep-Disordered Breathing ("SDB") due to adeno-tonsillar hypertrophy which are treated with the ENTire IRE System.

Subjects will be followed for six (6) months post-treatment. The objective of the study is to provide an ongoing safety and effectiveness assessment of the ENTire IRE System in treating pediatric adeno-tonsillar hypertrophy.

Are You a Good Fit for This Trial?

This trial is for children ages 3 to 12 who have trouble breathing during sleep because their tonsils and adenoids are enlarged. They must be able to undergo the procedure and follow-up visits.

Inclusion Criteria

I am between 3 and 12 years old.
My tonsils are moderately to severely enlarged.
My child has sleep-disordered breathing and is scheduled for adeno-tonsillar surgery.

Exclusion Criteria

I have a serious illness like cancer, severe autoimmune, neurological, or heart disease.
Any other reason the investigator deems the subject is unfit for participation in the study
Craniofacial anomalies
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What Are the Treatments Tested in This Trial?

Interventions

  • ENTire IRE System

Trial Overview

The study tests a device called the ENTire IRE System, which uses irreversible electroporation (a type of energy treatment) on enlarged tonsils and adenoids in kids with sleep-disordered breathing. All participants receive this treatment and are monitored for six months.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Enlarged tonsil(s) and/or adenoid mass will be reduced by ENTire IRE System.Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ENTire Medical Ltd.

Lead Sponsor

Trials
2
Recruited
80+

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