A Pilot Study to Assess Treatment of Patients With Homogeneous Emphysema Using Sequential Segmental Bronchoscopic Thermal Vapor Ablation (NEXT STEP)

NCT03670121 | Completed

• 1 other identifier: CSP-2346
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emphysema or COPD

Keywords

COPD, Emphysema, Homogenous, Collateral Ventilation; Vapor; Ablation

Outcome Measures

Primary Outcomes (3)

• Incidence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint)

  Occurrence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint)

  Baseline to 6 months

• Change in FEV1 (efficacy endpoint)

  Change in FEV1 (efficacy endpoint)

  Baseline to 6 months

• Change in St Georges Respiratory Questionnaire for COPD Patients (SGRQ-C) score (efficacy endpoint)

  This trial will utilize the SGRQ-C which is a shortened version of the SGRQ questionnaire. The SGRQ is a validated, disease-specific questionnaire that measures health-related quality of life in patients with COPD. The instrument has 3 domains (activity, symptoms, and impacts) and a total score. A Total and three-component scores are calculated: Symptoms; Activity; Impacts. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. Each component of the questionnaire is scored separately. Sum of maximum possible weights for each component and Total: Symptoms 566.2, Activity 982.9, Impacts 1652.8. Total (sum of maximum for all three components) 3201.9 Higher weights indicate worse outcomes. The difference in the domain scores and total score at follow-up visits relative to baseline will be calculated and reported.

  Baseline to 6 months

Secondary Outcomes (9)

• Change in FVC

  Baseline to 6 months

• Change in FRC

  Baseline to 6 months

• Change in RV

  Baseline to 6 months

• Change in TLC

  Baseline to 6 months

• Change in RV/TLC

  Baseline to 6 months

Study Arms (1)

BTVA Treatment

EXPERIMENTAL

All patients that will receive Bronchoscopic Thermal Vapor Ablation (BTVA) Treatment

Device: Bronchoscopic Thermal Vapor Ablation (BTVA)

Interventions

Bronchoscopic Thermal Vapor Ablation (BTVA) DEVICE

Bronchoscopic vapor delivery to airway segment(s) targeted for treatment

Also known as: BTVA, InterVapor

BTVA Treatment

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Arterial blood gas levels of: PaCO2 ≤ 50 mm Hg; PaO2 \> 45 mm Hg on room air
• Non-smoking for 2 months prior to study enrollment, as confirmed by negative urine point of contact strips or serum cotinine level of ≤ 10 ng/mL, or negative CO Hb test
• Optimized medical management (treatment consistent with GOLD guidelines)
• Evidence of completed pulmonary rehabilitation:
• ≥ 6 weeks out-patient or ≥ 3 weeks in-patient within 6 months of enrollment; or,
• Patient has or continues to participate in regular physical activity beyond activities of daily living (i.e. a walking program) for ≥ 6 weeks with 6 months of enrollment under the supervision of a health care professional
• Current influenza vaccination

You may not qualify if:

• 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
• 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
• Unstable COPD (any of the following):
• \>3 COPD related hospitalizations requiring antibiotics in past 12 months
• COPD related hospitalization in past 3 months
• daily use of systemic steroids, i.e. \> 5 mg prednisolone
• Single large bulla (defined as \> 1/3 volume of the lobe) or a paraseptal distribution of emphysema in lobe to be treated
• Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
• History of any of the following:
• Left ventricular ejection fraction (EF) ≤ 40%

Sponsors & Collaborators

• Uptake Medical Technology, Inc.: lead
• MedPass International: collaborator

Study Sites (1)

Thoraxklinik University of Heidelberg

Heidelberg, Germany

Location

Related Publications (1)

• Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

  PMID: 33590989 DERIVED

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Felix Herth

  Univ.-Prof. Felix JF Herth, Thoraxklinik University of Heidelberg Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm Pilot Study

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 13, 2018
• Study Start: August 28, 2018
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)