A Pilot Study to Assess Treatment of Patients With Homogeneous Emphysema Using Sequential Segment… (NCT03670121) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study to Assess Treatment of Patients With Homogeneous Emphysema Using Sequential Segmental Bronchoscopic Thermal Vapor Ablation (NEXT STEP)
Germany11 participantsStarted 2018-08-28
Plain-language summary
This study is a Prospective, single arm, single center pilot study following outcomes for 12 months after initial BTVA treatment. The primary objectives of the study are to prospectively document the safety and efficacy of sequential segmental treatment with BTVA in patients with a homogeneous distribution of emphysema that are not candidates for endobronchial valve therapy.
Who can participate
Age range40 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age \> or equal to 40 and ≤ 75 years old
✓. At least one lung with a homogeneous distribution of emphysema (defined as a heterogeneity index \< 1.2 when calculated as the ratio of upper lobe to lower lobe %-950 and when calculated as the ratio of lower lobe to upper lobe %-950) and a fissure integrity score \< 95% as measured by CT
✓. Contralateral lung (to lung targeted for the initial BTVA treatment) with tissue to air ratio \> 8%
✓. FEV1 between 20% and 45% predicted
✓. TLC \> or equal to 100% predicted
✓. RV \> or equal to 200% predicted
✓. Post-rehabilitation 6MWD \> 140 meters
✓. Marked dyspnea scoring \> or equal to 2 on the mMRC
Exclusion criteria
✕. Any condition that would interfere with the completion of the study, follow-up assessments, bronchoscopy, or that would adversely affect study outcomes. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with BTVA. Relevant examples of relevance include immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency
✕. DLCO \< 20% predicted or immeasurable DLCO
✕. BMI \< 18kg/m2 or \> 35 kg/m2
What they're measuring
1
Incidence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint)
Timeframe: Baseline to 6 months
2
Change in FEV1 (efficacy endpoint)
Timeframe: Baseline to 6 months
3
Change in St Georges Respiratory Questionnaire for COPD Patients (SGRQ-C) score (efficacy endpoint)
✕. Clinically significant bronchiectasis with more than 30 ml productive cough
✕. Heart and/or lung transplant, lung volume reduction surgery (LVRS), bullectomy, or thoracic surgery with removal of lung tissue
✕. Prior lung volume reduction via endobronchial valves(s), stent(s), coil(s), and/or polymer. Patients whose endobronchial valves have been removed can be treated if: all valves removed ≥ 6 months prior to BTVA and baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation
✕. Recent respiratory infections or COPD exacerbation in preceding 6 weeks