China Alair System Registry Study-CARE Study

BSC International Medical Trading

Status: Unknown

Conditions: Asthma

Treatments: Device: Alair System

Study type: Observational

Funder types: Other

Identifiers

NCT02206269

E7100

Details and patient eligibility

About

The objective of this Registry is to collect real-world outcome data for bronchial thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic despite taking standard of care maintenance medications.

Full description

Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and the anticipated reduction in healthcare utilization events and cost by way of a reduction in severe asthma exacerbations.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications.
2. Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the study requirements.
3. Patient is able to undergo bronchoscopy in the opinion of the Investigator or per hospital guidelines and as described in the Alair System Directions for Use (DFU).

Exclusion criteria

1. Patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
2. Patient has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.

Trial design

225 participants in 1 patient group

Alair System

Description:

This is a single arm study with Alair system used.

Treatment:

Device: Alair System