Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure

NCT ID: NCT02996149

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-12-31

Brief Summary

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Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.

Detailed Description

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Conditions

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Emphysema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Endoscopic lung volume reduction coil treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) \< 50% predicted and residual volume (RV) ≥ 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed
* Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg)
* Informed consent

Exclusion Criteria

* Therapeutic anticoagulation
* Anti-platelet therapy exceeding the use of acetylsalicylic acid
* Severe pulmonary hypertension
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Dr. Hans Klose

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PV-5379

Identifier Type: -

Identifier Source: org_study_id