New balloon could keep blocked airways open longer

NCT ID NCT05895305

What the study statuses mean

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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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a special balloon coated with a drug (paclitaxel) to treat non-cancerous narrowing of the central airways. The goal is to see if it is safe and helps keep the airway open longer than standard balloons. About 45 adults with severe airway blockage will be enrolled.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

45 people

The number who actually took part.

Started

May 2023

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged ≥18 old 4. Symptomatic, severe (\> 50%) benign CAO (by CT or bronchoscopy) 1. Stenosis is distal to cricoid and proximal to segmental bronchi 2. Indicated for balloon dilation only or as an adjunct to standard of care 3. Includes, but not limited to : * Post intubation tracheal stenosis (PITS) * Post tracheostomy tracheal stenosis (PTTS) * Post lung transplantation stenosis * Stenosis related to airway stent * Subglottic stenosis (SGS) * Stenosis due to tuberculosis Exclusion Criteria: 1. Malignant CAO 2. Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression 3. Presence of a known perforation at the site of proposed dilation 4. Presence of a known fistula between the tracheobronchial tree and esophagus, mediastinum to pleural space 5. Obstruction not amenable to bronchoscopic dilation in the opinion of the investigator 6. Allergy to paclitaxel or structurally related compounds 7. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure 8. Acute stricture condition that requires emergent procedure (e.g., immediate dilation) 9. Vasculitis that is not well controlled 10. Inability to tolerate bronchoscopy or contraindication to bronchoscopy, anesthesia, or deep sedation 11. Any anatomical limitation of the head and neck, oral cavity or laryngopharynx that may preclude bronchoscopic evaluation or treatment 12. Patient with active pulmonary infection, including but not limited to: COVID-19, influenza, etc. 13. Any disease or condition that interferes with safe completion of the study, such as severe COPD or severe asthma or pulmonary fibrosis. 14. Patients actively being treated with immunosuppressive therapy or with an active immunosuppressed state due to other treatment or underlying disease. 15. Pregnancy or planning on pregnant during the first 12 months of enrollment in the study 16. Life expectancy \<1 year 17. Patient is currently enrolled in other investigational studies. Participation in studies for products approved in the US are not considered investigational

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112, Georgia

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