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Post Market Registry Study of the AeriSeal System

A

Aeris Therapeutics

Status

Terminated

Conditions

Pulmonary Emphysema

Study type

Observational

Funder types

Industry

Identifiers

NCT01520064
03-C12-001PLV

Details and patient eligibility

About

  • Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting;
  • Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.

Enrollment

25 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Advanced Emphysema
  • AeriSeal System treatment

Exclusion criteria

  • have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis
  • have had frequent COPD exacerbations within the past year
  • require mechanical ventilatory support
  • have a pretreatment DLCO < 20% predicted or > 60% predicted
  • have a pretreatment FEV1 < 20% predicted AND homogeneous emphysema
  • have giant bullae
  • have undergone lung transplantation, lung volume reduction surgery, or lobectomy
  • are intolerant of corticosteroids or antibiotics
  • are pregnant or breast-feeding

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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