Health TrialsbyHealthPanel

Endobronchial Silicone Valve for Patients With Emphysema

ConditionEmphysema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital

About this trial

The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical and radiological evidence of emphysema

Nonsmoking for 4 months prior to screening interview

BMI less than 35 kg/m2

Stable on current medication regimen

Disqualifiers

Had two or more hospitalizations over the last year for a COPD exacerbation

Had two or more hospitalizations over the last year for pneumonia

Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy

Had a heart attack or congestive heart failure within the last 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • ESV

    Device

    This study arm will undergo ESV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

  • Optimal Medical Management (OMM)

    Other intervention

    This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

Treatment groups

147 Participants
are divided into 2 treatment groups
Group A: ESV and Optimal Medical ManagementExperimental treatment 1 intervention
Group B: Optimal Medical ManagementOther 1 intervention

Trial outcomes

Primary outcomes

1

Forced Expiratory Volume in 1-second (FEV1)

Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).

Time frame
1-year

Secondary outcomes

1

FEV1 Post-bronchodilator Absolute Change

Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).

Time frame
1 year
2

St. George's Respiratory Questionnaire (SGRQ)

Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline). The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.

Time frame
1 year
3

6-minute Walk Distance

Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China-Japan Friendship Hospital

Lead sponsor

Beijing Cardiotech Medical Technology CO., LTD

Collaborator

Source ClinicalTrials.gov
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