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Procedure
palatoplasty for Ear Infection
N/A
Waitlist Available
Led By Cuneyt M Alper, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
cleft palate with or without cleft lip classified as Veau I through IV
parental consent for procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by age 7 years
Awards & highlights
Study Summary
This study is evaluating whether a modified Furlow palatoplasty is more effective than the standard Furlow palatoplasty in reducing the duration of middle-ear disease in cleft palate patients.
Eligible Conditions
- Ear Infection
- Cleft Palate
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ by age 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by age 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Eustachian tube function (ETF) measures
hearing status
otitis media status
Secondary outcome measures
McKay-Kummer SMAP test
Pittsburgh Weighted Speech Score
Speech Therapy
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: modified Furlow palatoplastyExperimental Treatment1 Intervention
standard procedure plus modification
Group II: Furlow palatoplastyActive Control1 Intervention
standard procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
palatoplasty
2012
N/A
~90
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,258 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
178,222 Total Patients Enrolled
Cuneyt M Alper, MDPrincipal InvestigatorUniversity of Pittsburgh
10 Previous Clinical Trials
476 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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