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Lung valves could starve Drug-Resistant TB cavities

NCT ID NCT07296055

Disease control Sponsor: Azienda Ospedaliero-Universitaria Careggi 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 study tests whether placing one-way valves in the lungs can shrink cavities caused by drug-resistant tuberculosis (TB) or nontuberculous mycobacteria (NTM) infections. The valves block airflow into the cavity, creating a low-oxygen environment that may slow or stop bacterial growth. Thirty adults with cavities that cannot be surgically removed will be randomly assigned to receive either standard medical therapy alone or standard therapy plus the valve. The goal is to see if the valve helps reduce cavity size and clear bacteria from sputum after 9 months.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

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 to 80 years

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. Age between 18 and 80 years AND 2. Patient with cavities deemed unsuitable for surgery (when an extensive pulmonary parenchymal damage due to TB, is present, making patients inappropriate for open thoracic surgery) AND 3. To have signed the informed consent AND one of the following conditions: 4. Pulmonary MDR/XDR -TB or NTM (difficult to treat or resistant to treatment) confirmed by smear samples and antibiogram or with persistence of positivity for Mycobacterium of the smear after standard pharmacotherapy and severe destruction of the lungs with 1 or more persistent cavities. 5. Pulmonary TB or NTM with cavities and associated systemic diseases such as pancreatic diabetes, stomach and duodenum ulcer, liver and kidney diseases, HIV or another such disease that compromises pharmacological treatment. 6. Recurrent haemoptysis attributable to TB or NTM Exclusion Criteria: 1. Contraindication to performance of bronchoscopy 2. Severe cardiac comorbidities 3. Severe psychiatric disorders 4. Functional or anatomical pneumonectomy 5. Asthma 6. Pregnancy 7. Patients for whom bronchoscopic procedures are contraindicated 8. Patients with known allergies to Nitinol (nickel-titanium) or its constituent metals (nickel or titanium) 9. Patients with known allergies to silicone 10. Patients who have not quit smoking 11. Patients with large bullae encompassing greater than 30% of either lung 12. Patients with active pulmonary infection

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Conditions

The condition(s) this trial relates to.

extensively drug-resistant tuberculosis multidrug-resistant tuberculosis pulmonary non-tuberculous mycobacterial infection

As listed by the trial registrant

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

Multidrug resistance tubercolosis Non tubercolar micobacteriosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Careggi

    Florence, FI, 50134, Italy