Endobronchial Valves + Blood Patch for Pneumothorax

Overseen By Christine Conley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Experimental treatments, Cardiovascular instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating persistent air leaks (PALs), which are stubborn lung air leaks that can slow recovery and extend hospital stays. Researchers aim to determine if endobronchial valves (tiny devices placed in the airways) combined with a blood patch (using the patient's blood to seal the leak) can expedite the repair of these leaks. Participants will undergo a bronchoscopy (a procedure to examine the lungs) to evaluate this combined treatment. This trial targets adults with PALs who cannot or choose not to undergo surgery. As an unphased trial, it offers patients the chance to explore innovative treatment options that might not be available elsewhere.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for treating persistent air leaks?

Research has shown that using endobronchial valves and blood patches is generally safe for treating ongoing air leaks in the lungs. In one study, about 61% of patients experienced cessation of air leaks within 30 days after receiving valve treatment, with no procedure-related deaths reported.

Another study found that the treatment successfully stopped air leaks in 36% of patients, with only a few experiencing a recurrence. While it might not work for everyone, most patients tolerate the treatment well.

Overall, these findings suggest that the treatment is safe, with most patients achieving good results and experiencing no serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for persistent air leaks, which often involve surgical interventions or prolonged chest tube management, this innovative approach uses a combination of endobronchial valve placement and endobronchial blood patching. Researchers are excited about this treatment because it offers a minimally invasive, nonsurgical option that directly targets and manages air leaks. This method could significantly reduce recovery times and complications associated with more invasive procedures, providing a new hope for patients who aren't suitable candidates for surgery or those who prefer to avoid it.

What evidence suggests that this technique is effective for persistent air leaks?

Research has shown that endobronchial valves (EBVs) can help treat persistent air leaks (PALs). In one study, about 60.6% of patients had their air leaks resolved within 30 days after receiving EBV treatment. Another study found that EBVs significantly reduced air leaks in 9% of patients. In this trial, participants will receive a combination of EBVs and a blood patch, which may improve these results, offering a promising option for those with PALs. Although complications can occur, no deaths related to the procedure have been reported. Overall, this method provides a less invasive way to manage air leaks, potentially leading to quicker recovery and shorter hospital stays. ^{1 3 4 6 7}

Who Is on the Research Team?

Jason Beattie, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with persistent air leaks, a condition that can extend hospital stays and delay recovery. Participants must be undergoing bronchoscopy to locate the source of the air leak. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am not eligible for or have refused surgery for my PAL condition.

I am an adult with persistent air leaks from surgery, injury, or lung disease.

Exclusion Criteria

Patients who have received other experimental or investigational treatments for PALs that could confound the results

I cannot have a bronchoscopy due to severe heart issues or other medical reasons.

I have a connection between my lung and chest wall.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bronchoscopy with endobronchial valve placement and endobronchial blood patching for persistent air leaks

1 day

1 visit (in-person)

Follow-up

Participants are monitored for resolution of air leaks and post-procedure outcomes through standard inpatient monitoring

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Endobronchial Valve Placement and Endobronchial Blood Patching

Trial Overview The PATCHVALVE study tests if combining endobronchial valve placement with blood patching speeds up the healing of persistent air leaks in patients' lungs. It involves standard bronchoscopy, instilling patient's own blood mixed with TXA into their lung, then placing a valve to seal off leaks.

How Is the Trial Designed?

Group I: Bronchoscopic Endobronchial Valve and Blood Patch Treatment Group for Persistent Air Leak Management Experimental Treatment 2 Interventions

This study will enroll patients with persistent air leaks (PAL) following lung resection or unrelated to lung resection, who have ipsilateral chest tubes in place and are either not suitable candidates for surgical intervention or have declined surgery. Participants will undergo a combined bronchoscopic approach involving endobronchial valve (EBV) placement and endobronchial blood-patch application, aiming to effectively manage air leaks through a minimally invasive, nonsurgical technique.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4332267/

Endobronchial Valves in Treatment of Persistent Air Leaks EBVs were removed after the cessation of air leak in 17/39 patients (46%). Following the EBV treatment, complications were reported in 2 cases; 1 developed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07184528

Endobronchial Valves Plus Blood Patch for Persistent Air ... The goal of this study is to evaluate the real-world safety and effectiveness of combining endobronchial valve (IBV) placement with endobronchial blood ...

3. karger.com karger.com/res/article/103/9/544/909223/Endobronchial-Valves-in-Treatment-of-Persistent

Endobronchial Valves in Treatment of Persistent Air Leak Air leak resolved in 40/66 patients (60.6%) within 30 days after EBV treatment. Concerning safety outcome, no procedure-related mortality was ...

4. jtd.amegroups.org jtd.amegroups.org/article/view/24924/html

Unidirectional endobronchial valves for management of ... In 6/67 (9%) patients, EBV implant led to a significant reduction in the amount of air leak, and adjuvant treatments such as pneumo-peritoneum and autologous ...

5. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-017-0666-y

Endobronchial one-way valves for treatment of persistent air ... Outcome of endobronchial one-way valves deployment: optimal decrease of air leak was gained posterior valve deployment within less than 24 h in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12557625/

Endobronchial valve placement for persistent air leaks in ... Our results suggest that EBV placement may be superior to prolonged chest tube suction in this subpopulation. Early intervention may translate into greater cost ...

7. thorax.bmj.com thorax.bmj.com/content/79/Suppl_2/A226.2

P197 Endobronchial valve management of persistent air ... EBV was successful with 86% of patients discharged and 8 patients had drains removed within 3 days whereas another 15 patients between 3–7 days. Most (72%) ...