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Device

Ear Tube Insertion Device for Ear Infections (VENTY Trial)

N/A
Recruiting
Research Sponsored by AventaMed DAC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

VENTY Trial Summary

This trial studies a new device for inserting tubes in kids' ears to treat hearing problems.

Who is the study for?
This trial is for children aged 6 months to under 13 years who need ear tubes inserted due to infections. They must be able to attend follow-up visits.Check my eligibility
What is being tested?
The study is testing the Solo+ Tympanostomy Tube Device (Solo+ TTD) for safety and effectiveness in placing ear tubes during a standard procedure in pediatric patients.See study design
What are the potential side effects?
Potential side effects are not specified, but may include typical risks associated with tympanostomy procedures such as pain, infection, or hearing issues.

VENTY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Procedure Success
Rate of Adverse Events

VENTY Trial Design

1Treatment groups
Experimental Treatment
Group I: Solo+ Tympanostomy Tube Device (Solo+ TTD)Experimental Treatment1 Intervention
The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure.

Find a Location

Who is running the clinical trial?

AventaMed DACLead Sponsor
3 Previous Clinical Trials
74 Total Patients Enrolled
Matija DanielStudy ChairQueen's Medical Center
3 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

Solo+ Tympanostomy Tube Device (Solo+ TTD) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05741333 — N/A
Ear Infection Research Study Groups: Solo+ Tympanostomy Tube Device (Solo+ TTD)
Ear Infection Clinical Trial 2023: Solo+ Tympanostomy Tube Device (Solo+ TTD) Highlights & Side Effects. Trial Name: NCT05741333 — N/A
Solo+ Tympanostomy Tube Device (Solo+ TTD) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05741333 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants aged 75 and younger being considered for this research project?

"This clinical trial has specific parameters for eligibility. Participants must fall between 6 months and 13 years old to be admitted; there are 19 studies dedicated to minors, whereas the elderly have 4 options available."

Answered by AI

Are there any unfilled slots remaining in this experiment?

"The records on clinicaltrials.gov demonstrate that this trail is actively looking for participants, having been initially posted March 30th 2023 and most recently edited May 4th 2023."

Answered by AI

What is the maximum capacity for participants in this medical experiment?

"Affirmative. Clinicaltrials.gov documents that this research initiative, initially posted on March 30th 2023, is presently enrolling participants. 66 individuals are set to be recruited from two separate locations."

Answered by AI

Is participation in this trial open to the public?

"This research endeavour seeks 66 participants aged 6 months to 13 years old who have ear infection and meet the following criteria: planned tympanostomy tube insertion; commitment to follow-up visits and assessments."

Answered by AI
~43 spots leftby Jun 2026