Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

U

Uptake Medical

Status and phase

Completed
Phase 1

Conditions

Chronic Obstructive Pulmonary Disease
Emphysema

Treatments

Device: BTVA System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01041586
VAPOR-US

Details and patient eligibility

About

To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.

Full description

All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. Immediately prior to BTVA treatment, an initial bronchoscopy will be performed to evaluate the baseline condition of the airways and to confirm anatomy of the lung segments targeted for BTVA treatment. Up to 3 segments in either the right or left upper lobe will be treated with a vapor dose of 10 calories per gram of lung tissue (10 cal/g). Targeted lobe for treatment will be based on lobar disease severity.

Enrollment

10 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: > 40 and ≤ 75 years old
  • Diagnosis of heterogeneous emphysema with upper lobe predominance
  • FEV1 < 45% predicted
  • TLC > 100% predicted
  • RV > 150% predicted
  • 6-minute walk test > 140 meters
  • mMRC ≥ 2 (mMRC)
  • Non-smoking for 3 months
  • Optimized medical management and completed pulmonary rehabilitation

Exclusion criteria

  • Known α-1-antitrypsin deficiency
  • BMI < 15 kg/m2 or > 35 kg / m2
  • History of pneumothorax within previous 18 months
  • History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
  • Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection
  • History of the (EF) ≤ 40%; Stroke; Unstable Myocardial Ischemia; FEV1 < 15% predicted; DLCO < 20% predicted; of pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

BTVA
Experimental group
Treatment:
Device: BTVA System

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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