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Precision steam treatment could help emphysema patients breathe easier

NCT ID NCT06152107

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new way to treat severe emphysema using heated water vapor (InterVapor) to shrink damaged lung tissue. Researchers want to see if treating smaller, targeted areas (subsegments) works better than treating larger sections. 100 adults with severe emphysema will be randomly assigned to one of two procedure types, and their lung function and quality of life will be tracked for up to a year.

What this could mean

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

Active substance
InterVapor (heated water vapor) procedure
What this could lead to
If it works, this could offer a more targeted, less invasive way to improve breathing and quality of life for people with severe emphysema.
What could go wrong
This is an early-stage, 100-person trial comparing two procedure types, not a new drug. The benefits may be small or not last long, and there are risks from the procedure itself.

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 100 people

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

Started

Jan 2024

Expected to finish

Dec 2027

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 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. Age≥18 years old; 2. Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT; 3. Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study; 4. 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%); 5. 6MWD \>140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test) 6. mMRC score≥2; 7. Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2\>50 mmHg on room air; 8. Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment. Exclusion Criteria: 1. Contraindications to bronchoscopy, such as: Prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (EF) ≤ 40%; Active haemoptysis; Coagulation disorders; Malignant cardiac arrhythmia, severe pulmonary hypertension, extreme systemic failure, etc; 2. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency; 3. Use of morphine derivatives within 4 weeks prior to screening; 4. Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit; 5. Recent COPD exacerbation in preceding 6 weeks; 6. Severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %LAA-950 assessed by HRCT as a percentage of whole lung lobe volume \> 40%; 7. Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe; 8. Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.); 9. History of heart and/or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, thoracic surgery with removal of lung tissue and endobronchial lung volume reduction (via valves, coils, stents, etc.); 10. Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist; 11. Pregnant or breastfeeding; 12. Current enrollment in any other investigational study which has not completed requisite follow-up; 13. Any conditions assessed by investigator that make patients inappropriate for enrolment.

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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.

How to take part

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

  1. The places running it

    9 sites. 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

  • Emergency General Hospital

    NOT_YET_RECRUITING

    Beijing, 100028, China

  • Hebei Provincial People's Hospital

    NOT_YET_RECRUITING

    Shijiazhuang, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Jiangxi Provincial People's Hospital

    NOT_YET_RECRUITING

    Nanchang, China

  • Linyi People's Hospital

    NOT_YET_RECRUITING

    Linyi, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, 200030, China

  • Shanghai Sixth People's Hospital

    NOT_YET_RECRUITING

    Shanghai, China

  • Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

    RECRUITING

    Zhejiang, 310009, China

  • West China Hospital of Sichuan University

    NOT_YET_RECRUITING

    Chengdu, 610041, China

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