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Search / Trial NCT06738927

Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip) (EFEOF)

Launched by UNIVERSITY HOSPITAL, BREST · Dec 13, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Serous Otitis Tympanic Membrane Perforation Retraction Pocket Cholesteatoma Otorrhea Myringosclerosis Tympanosclerosis Audiometric Tests Ent Transtympanic Ventilatory Tubes. Cleft Palate

ClinConnect Summary

This clinical trial, called the Otological Study of Facial Cleft Patients Over 10 Years of Age (EFEOF), is designed to investigate ear health in patients with facial clefts who are over the age of 10. The focus is on understanding the benefits of a specific treatment called transtympanic ventilatory tubes, which are small tubes placed in the ear to help with conditions like fluid buildup, ear infections, and other ear-related issues. Current studies have shown mixed results about how effective this treatment is, so this trial aims to gather more reliable data to help doctors make better decisions for patients with cleft palates.

To be eligible for this trial, participants should have had a facial cleft between 2004 and 2014 and be followed by ear, nose, and throat (ENT) specialists at certain hospitals in France. People who are under legal guardianship, refuse to participate, or have only an isolated cleft lip will not be included. If you or a family member qualifies and chooses to participate, you can expect to contribute to important research that could improve ear health management for others with similar conditions in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Presence of a facial cleft between 2004 and 2014 Minor and adult patients Followed up by ENT services at the University Hospital of Brest or Marseille
  • Exclusion Criteria:
  • Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate Objection from one of the parents Isolated cleft lip No ENT follow-up

About University Hospital, Brest

The University Hospital of Brest is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and comprehensive patient care. With a strong emphasis on interdisciplinary collaboration, the hospital serves as a hub for cutting-edge clinical trials aimed at improving treatment outcomes across various medical specialties. Leveraging its robust academic affiliations and state-of-the-art facilities, the University Hospital of Brest is committed to fostering scientific discovery and enhancing the quality of life for patients through evidence-based practices and pioneering research initiatives.

Locations

Brest, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported