Post Market Registry Study of the AeriSeal System

Pulmonary Emphysema Clinical Trial

Official title:

Post Market Registry Study of the AeriSeal System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01520064
• Other study ID #: 03-C12-001PLV
• Status: Terminated
• Phase: N/A
• First received: January 25, 2012
• Last updated: November 13, 2013
• Start date: February 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionIsrael: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Klinikum Coburg	Coburg
Germany	Klinikum Donaustauf	Donaustauf
Germany	Asklepios Fachkliniken Muenchen-Gauting	Gauting
Germany	Universitatsklinikum Halle	Halle
Germany	Asklepios Klinik Hamburg-Harburg	Hamburg
Germany	Thoraxklinik am Uniklinikum Heidelberg	Heidelberg
Germany	Sana Kliniken Luebeck	Luebeck
Germany	Klinikum Nuerberg Nord	Nurnberg
Germany	Bethanien KH Solingen	Solingen
Israel	Soroka Medical Center	Beer Sheeva
Israel	Rabin Medical Center, Beilinson Campus	Petach Tikvah

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Market Registry Study of the AeriSeal System	-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-martet setting	At least 4 years	No