Endoscopic Lung Volume Reduction Coil Treatment in Patien... | NCT02996149

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

NCT02996149

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Terminated

Last Update Posted

Dec 24, 2019Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Emphysema

Interventions

Endoscopic lung volume reduction coil treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Technique no longer available

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Nov 16, 2016

First Submission Date that Met QC Criteria

Dec 16, 2016

First Posted Date

Dec 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2019

Last Update Posted Date

Dec 24, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Hans Klose, Dr., Universitätsklinikum Hamburg-EppendorfPrincipal Investigator

Lead Sponsor

Universitätsklinikum Hamburg-EppendorfOTHER

Collaborators

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic lung volume reduction coil treatment	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in PaCO2		3 months after endoscopic lung volume reduction (ELVR)

Secondary Outcomes

Measure	Description	Time Frame
Changes in PaCO2		6 and 12 months after ELVR
Changes in FEV1		3, 6 and 12 months after ELVR
Changes in vital capacity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with severe emphysema and chronic hypercapnic respiratory failure, in whom endoscopic lung volume reduction coil treatment is performed

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Hamburg-Eppendorf		Hamburg			Germany

Condition Browse Module

MeSH Terms

ID	Term
D004646	Emphysema

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided