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Balloon treatment for sinusitis may offer faster recovery and less pain

NCT ID NCT02509663

Symptom relief Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared a newer, less invasive procedure called balloon sinuplasty to standard surgery for people with frontal sinusitis that did not improve with medication. The balloon procedure uses a small catheter to open blocked sinus passages, aiming to reduce pain, bleeding, and recovery time. The trial was stopped early after enrolling only 9 participants, so the findings are not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Balloon sinuplasty procedure
What this could lead to
If successful, this could offer a less painful, faster-recovery option for people with stubborn frontal sinusitis, reducing the need for more invasive surgery.
What could go wrong
The trial was terminated early with only 9 participants, so results are very limited. It is unclear if balloon sinuplasty is truly better or safer than standard surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Jun 2018

Finished

Jul 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Man or woman of age ≥ to 18 years. * Patient for which a frontal sinus surgery (Draf 1 type) is programmed for any type of frontal sinusitis unresponsive to drug treatment properly leads. * Patient affiliated to a social protection scheme Written informed consent of the patient * Signed informed consent Exclusion Criteria: * Polyposis sinonasal or other sinus to be the subject of a simultaneous complementary intervention * Sinuso-nasal tumors * Osteogenesis * Fragile patients or patient needing gesture contraindicating surgery by rigid instrumentation * Contraindication with balloon using * Contraindication to general anesthesia * Immunosuppressive therapy * Patient under judicial protection * Pregnancy or Breastfeeding * Exclusion period determinated with concurrent participation in other experimental studies * Contrast medium allergy background * Impossibility to give the informed study documentation to the subject (emergency situation, lack of understanding, etc...)

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Conditions

The condition(s) this trial relates to.

frontal sinusitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Frontal sinusitis

Contacts and locations

Locations

  • ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals

    Strasbourg, 67000, France

  • Service ORL Institut Arthur Vernes

    Paris, 75000, France

  • Service ORL et de Chirurgie Cervico-Faciale

    Nantes, 44000, France

  • Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey

    Toulouse, 31000, France

  • Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin

    Bordeaux, 33000, France

  • Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière

    Paris, 75000, France

  • Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie

    Poitiers, 86000, France

  • Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000, France

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