Boston, MANCT04801108Now EnrollingIRB Ready

Emphysema or COPD Clinical Trial in Boston, MA

Access cutting-edge emphysema or copd treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Beth Israel Deaconess Medical Center

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Expert Care in Boston

Access emphysema or copd specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related emphysema or copd treatment provided free

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Check if you qualify for this emphysema or copd clinical trial in Boston, MA

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Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Emphysema or COPD Study in Boston

The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients with severe COPD/emphysema and with evidence for \<95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling. The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD/emphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F/U period, they will be eligible for EBV if they choose.

Sponsor: Beth Israel Deaconess Medical Center

Who Can Participate

Inclusion Criteria

Age 40 to 75 years.
Stable with less than 10mg prednisone (or equivalent) daily.
Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.
Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 12 months prior.
Current pneumococcus vaccination.
Current influenza vaccination.
Willing and able to complete protocol required study follow-up assessments and procedures.

Exclusion Criteria

\> 95% fissure completion on high-resolution chest CT-scan (HRCT) or StratX evaluation with a Chartis evaluation negative for collateral ventilation.
Clinically significant (greater than 4 tablespoons per day) mucus production.
Myocardial infarction within 6 months of screening.
Uncontrolled congestive heart failure.
Three or more pneumonia episodes in last year.
Three or more COPD exacerbation episodes in the last year.
Prior lung transplant, LVRS, bullectomy, or lobectomy.
Clinically significant bronchiectasis.
Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.
Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
Resting bradycardia (\<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT.
Post-bronchodilator FEV1 less than 15% or greater than 45% of the predicted value at screening.
TLC less than 100% predicted (determined by body plethysmography at screening).
RV less than 150% predicted in patients with heterogeneous emphysema or less than 200% predicted in patients with homogeneous emphysema (determined by body plethysmography at screening).
DLCO less than 20% of the predicted value at screening.
Post-rehabilitation 6-minute walk distance less than 100 meters or greater than 450 meters at screening.
PaCO2 greater than 50mmHg on room air at screening.
PaO2 less than 45mmHg on room air at screening

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT04801108) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Emphysema or COPD Treatment Options in Boston, MA

If you're searching for emphysema or copd treatment options in Boston, MA, this clinical trial (NCT04801108) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced emphysema or copd specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all emphysema or copd clinical trials near you to find additional studies recruiting in your area.

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