NCT02123277

Brief Summary

The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

3.6 years

First QC Date

March 3, 2014

Last Update Submit

May 18, 2018

Conditions

Eustachian Tube Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Tubal score

    at 1st day, and 2 months

Study Arms (1)

concept proof

EXPERIMENTAL

Balloon catheter for the Eustachian tube

Device: Balloon catheter for the Eustachian tube

Interventions

Balloon catheter for the Eustachian tubeDEVICE

Balloon catheter is inserted in the Eustachian tube to dilate it.

concept proof

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients between 20 and 80 years old
  • tubal score lower than 5
  • patients who already used reference medical treatment

You may not qualify if:

  • patients who already do a major surgery of middle ear
  • tympanic perforation
  • pregnant or breastfeeding woman.
  • patients who can't be follow during 14 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gui de Chauliac Hospital

Montpellier, 34090, France

Location

Related Publications (2)

  • Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.

    PMID: 40008607DERIVED

  • Kaderbay A, Karkas A, Schmitt D, Mura T, Lavieille JP, Venail F. Balloon dilation for persistent unilateral chronic obstructive Eustachian tube dysfunction is effective: a prospective multicentre study. Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1101-1109. doi: 10.1007/s00405-022-07578-2. Epub 2022 Aug 6.

    PMID: 35932313DERIVED

Study Officials

  • Frederic VENAIL

    CHRU Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

April 25, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

FR(1)