NCT02996149

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

3.1 years

First QC Date

November 16, 2016

Last Update Submit

December 20, 2019

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

  • Changes in PaCO2

    3 months after endoscopic lung volume reduction (ELVR)

Secondary Outcomes (7)

  • Changes in PaCO2

    6 and 12 months after ELVR

  • Changes in FEV1

    3, 6 and 12 months after ELVR

  • Changes in vital capacity

    3, 6 and 12 months after ELVR

  • Changes in residual volume

    3, 6 and 12 months after ELVR

  • Changes in 6-minute walk distance

    3, 6 and 12 months after ELVR

  • +2 more secondary outcomes

Interventions

Endoscopic lung volume reduction coil treatmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Therapeutic anticoagulation
  • Anti-platelet therapy exceeding the use of acetylsalicylic acid
  • Severe pulmonary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, Germany

Location

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 16, 2016

First Posted

December 19, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Locations

DE(1)