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Completed

NCT Number: NCT04136977

XprESS ET Registry

A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).

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Key information

Conditions

Eustachian Tube Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Breathe Clear Institute, Torrance, California, United States

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About this study

This is a prospective, multicenter, single-arm, postmarket registry enrolling up to 300 participants who are planning to undergo balloon dilation of the Eustachian tubes for treatment of chronic/persistent Eustachian tube dysfunction (ETD). Procedural information will be collect as well as efficacy and safety data through 6 months post procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be at least 18 years old
  • Have been diagnosed with persistent/chronic Eustachian tube dysfunction (duration 3 months or more)
  • Be a candidate for unilateral or bilateral Eustachian tube balloon dilation using the XprESS device
  • Be able to read and understand English
  • Be willing and able to provide informed consent
  • Be willing to comply with the protocol requirements

Exclusion criteria

  • Have a history of patulous Eustachian tube
  • Require additional ear surgery (eg, myringotomy, tympanostomy) at the time of study procedure
  • Have evidence of internal carotid artery dehiscence
  • Be currently participating in any other drug or device clinical studies, excluding postapproval or marketing registry studies

Treatment and study plan

Eustachian tube dilation

Device

Unilateral or bilateral balloon dilation of the Eustachian tube using the FDA-cleared XprESS ENT Dilation System

Other names: XprESS ET balloon dilation

Primary outcomes

  1. Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score

    Time frame: 6 Months

    Change from baseline to follow-up in the mean overall ETDQ-7 score. The ETDQ-7 is a validated 7-item patient-reported questionnaire reporting the presence and severity of symptoms associated with Eustachian tube dysfunction. Each item is scored from 1 (normal) to 7 (severe). The overall score is the mean score of the 7 items.

  2. Complication rate

    Time frame: 6 Months

    Percentage of participants who experience 1 or more serious adverse events that are related to the device and/or procedure.

Secondary outcomes

  1. Procedural information

    Time frame: Procedure through 6-week follow-up

    Details of the balloon dilation procedure, including setting, anesthesia, technical success, concomitant procedures, procedure/device-related adverse events, and recovery time.

  2. Minimal clinically important difference in ETDQ-7 score

    Time frame: 6 Months

    Percentage of participants achieving the minimal clinical important difference in overall ETDQ-7 score (reduction from baseline of 0.5 points or more). The ETDQ-7 is a validated 7-item patient-reported questionnaire reporting the presence and severity of symptoms associated with Eustachian tube dysfunction. Each item is scored from 1 (normal) to 7 (severe). The overall score is the mean score of the 7 items.

  3. Revision Eustachian tube dilation

    Time frame: 6 Months

    Percentage of participants who require revision dilation on an ear that was treated in the initial procedure.

  4. Surgical interventions

    Time frame: 6 Months

    Percentage of participants requiring surgical ear intervention (other than balloon dilation) on an ear that was treated in the initial procedure but has recurrent or continuing ETD symptoms.

  5. Participant satisfaction: Proportion of participants indicating satisfaction and willing to recommend the procedure to friends or family

    Time frame: 6 Months

    Percentage of participants indicating satisfaction and willing to recommend the procedure to friends or family.

  6. Change in work productivity/activity impairment

    Time frame: 6 Months

    Participants complete the validated Work Productivity and Activity Impairment (WPAI) at baseline and 6 month follow-up. The questionnaire consists of 6 questions that evaluate absenteeism, presenteeism, work productivity loss, and activity impairment over the previous week. Results are expressed as the percentage of impairment from 0 to 100, for which higher numbers indicate worse outcomes (ie, greater impairment and less productivity). Absenteeism is calculated by dividing the number of hours missed by the sum of the numbers of hours missed plus the number of hours worked. Presenteeism, is calculated by dividing the response to productivity at work question by 10, while activity impairment is calculated by dividing the response to the ability to carry out daily activities question by 10. Finally, the overall work impairment/productivity loss is calculated as the sum of absenteeism and the product of presenteeism and time at work.

  7. Change from baseline in chronic rhinosinusitis symptoms

    Time frame: 6 Months

    Participants will complete the validated 22-item SinoNasal Outcomes Test (SNOT-22) to evaluate change in chronic rhinosinusitis symptoms. Each of the 22 symptoms on the questionnaire are rated by the participant from 0 (no problem) to 5 (bad). A sum of the 22 item scores provides the overall score, which can range from 0 to 110.

  8. Improvement in tympanogram

    Time frame: 6 Months

    Percentage of participants with an abnormal tympanogram (type B or C) at baseline who have a normal (type A) or improved (type B to type C) tympanogram at follow-up.

  9. Improvement in ability to perform a Valsalva maneuver

    Time frame: 6 Months

    Percentage of participants unable to perform the Valsalva maneuver (negative) at baseline who are able to perform the maneuver (positive) at follow-up.

  10. Improvement in tympanic membrane position

    Time frame: 6 Months

    Percentage of participants with a retracted tympanic membrane at baseline who have a normal tympanic membrane position at follow-up.

Sponsors and collaborators

Lead sponsor

Entellus Medical, Inc.

Industry

Collaborators

  • North American Science Associates Ltd.

Registry information

Official study title

XprESS Eustachian Tube Balloon Dilation Registry

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2019
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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