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Procedure
Radiofrequency Ablation for Chronic Rhinitis
N/A
Recruiting
Led By David Z Allen, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,12 weeks post intervention
Awards & highlights
Study Summary
This trial assesses the effectiveness of a procedure to treat chronic rhinitis by comparing patient symptoms, airflow and cytokines before and after.
Who is the study for?
This trial is for people who've had chronic rhinitis symptoms like runny nose, congestion, and post-nasal drip for over 6 months and haven't seen improvement despite trying medical treatments for at least a month. They should have specific minimum scores on symptom scales. Those with immune system issues, recent sinus surgery, active sinus infections or frequent nosebleeds can't participate.Check my eligibility
What is being tested?
The study tests the effectiveness of Radiofrequency Ablation (RFA) therapy on patients with chronic rhinitis by observing changes in their nasal symptom scores, breathing flow through the nose, and levels of certain inflammatory substances before and after treatment.See study design
What are the potential side effects?
Potential side effects from RFA may include temporary pain or discomfort in the treated area, swelling, bleeding from the nose, infection risk at the site of ablation, or short-term worsening of nasal symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline,12 weeks post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,12 weeks post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in levels of type 2 cytokines
Change in nasal congestion as assessed by the peak nasal inspiratory flow (PNIF)
Secondary outcome measures
Change in nasal congestion as assessed by the reflective total nasal symptom score (rTNSS)
Change in nasal obstruction as assessed by the nasal obstruction symptom evaluation survey (NOSE)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radiofrequency ablation (RFA)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiofrequency ablation (RFA)
2018
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,941 Total Patients Enrolled
American Academy of Otolaryngic Allergy & FoundationUNKNOWN
1 Previous Clinical Trials
33 Total Patients Enrolled
David Z Allen, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a weakened immune system due to an illness or past sinus surgery.You have ongoing sinus infection.You have a condition called rhinitis medicamentosa.You have had ongoing symptoms of runny or stuffy nose and post-nasal drip for at least 6 months.You have frequent and ongoing nosebleeds.You didn't get better after trying a certain treatment for at least 4 weeks.You have a stuffy or runny nose with a total score of at least 6.
Research Study Groups:
This trial has the following groups:- Group 1: Radiofrequency ablation (RFA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial still recruiting participants?
"Based on the information found on clinicaltrials.gov, this particular study is no longer enrolling patients as it was last edited over a month ago. However, an array of 66 other trials are presently recruiting across various medical centres."
Answered by AI
Are there any elderly participants in this experimentation?
"Those between 18 and 65 years old are eligible to apply for this clinical trial. However, there are 24 trials available for those younger than 18 and 45 studies targeting patients over the age of 65."
Answered by AI
Is there still an opportunity to enroll in this clinical experiment?
"This clinical study requires 36 individuals suffering from rhinitis between 18 and 65. To be eligible, hopefuls must have had symptoms of chronic rhinitis for at least 6 months (runny nose, congestion, post-nasal drip), attempted medical management with no effect lasting 4 weeks or more, a rTNSS score ≥6 inclusive of >=2 in regards to runny nose and 1+ concerning nasal blockage."
Answered by AI
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