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Trial record 3 of 10 for:    pneumrx [Lead]

Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02499380
Recruitment Status : Terminated (Study enrollment was prematurely stopped.)
First Posted : July 16, 2015
Results First Posted : June 25, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Emphysema
Intervention Device: PneumRx Coil System
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

Patients treated with PneumRx Coil System

PneumRx Coil System

Period Title: Overall Study
Started 20
Completed 17
Not Completed 3
Arm/Group Title Treatment
Hide Arm/Group Description

Patients treated with PneumRx Coil System

PneumRx Coil System

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
66.50  (5.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
11
  55.0%
Male
9
  45.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Changes in 6 Minute Walk Distance (6MWD)
Hide Description Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters.
Time Frame Baseline, 12 months post initial treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population with 6MWT data available at baseline and 12 months
Arm/Group Title Treatment
Hide Arm/Group Description:

Patients treated with PneumRx Coil System

PneumRx Coil System

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: meters
19.1  (63.06)
2.Primary Outcome
Title Changes in 6 Minute Walk Distance (6MWD)
Hide Description Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters.
Time Frame Baseline, 3 months post final treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population with 6MWT data available at baseline and 3 months
Arm/Group Title Treatment
Hide Arm/Group Description:

Patients treated with PneumRx Coil System

PneumRx Coil System

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: meters
21.4  (46.94)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description Patients treated with PneumRx Coil System
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   10/20 (50.00%)    
General disorders   
Condition aggravated   1/20 (5.00%)  1
Implant site reaction   1/20 (5.00%)  1
Immune system disorders   
Anaphylactic reaction   1/20 (5.00%)  1
Infections and infestations   
Infective exacerbation of chronic obstructive pulmonary disorders   1/20 (5.00%)  1
Post procedural pneumonia   1/20 (5.00%)  1
Reproductive system and breast disorders   
Fibrocystic breast disease   1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disorder   3/20 (15.00%)  3
Dyspnoea   2/20 (10.00%)  2
Pneumothorax   2/20 (10.00%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%) # Events
Total   16/20 (80.00%)    
General disorders   
General Physical Health Deterioration   1/20 (5.00%)  1
Chest Discomfort   1/20 (5.00%)  1
Infections and infestations   
Respiratory Tract Infection   2/20 (10.00%)  2
Infective Exacerbation of Chronic Obstructive Airways Disease   1/20 (5.00%)  1
Nasopharyngitis   1/20 (5.00%)  1
Pneumonia Bacterial   1/20 (5.00%)  1
Herpes Zoster   1/20 (5.00%)  1
Injury, poisoning and procedural complications   
Tendon Rupture   1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia   1/20 (5.00%)  1
Psychiatric disorders   
Depression   2/20 (10.00%)  2
Respiratory, thoracic and mediastinal disorders   
Chronic Obstructive Pulmonary Disorder   10/20 (50.00%)  13
Dyspnoea   2/20 (10.00%)  3
Haemoptysis   1/20 (5.00%)  1
Cough   1/20 (5.00%)  1
Surgical and medical procedures   
Mastectomy   1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jörg Rennecke
Organization: PneumRx
Phone: +49 211 5422750
EMail: medical.services@btgplc.com
Layout table for additonal information
Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT02499380     History of Changes
Other Study ID Numbers: CLN0017
First Submitted: May 27, 2015
First Posted: July 16, 2015
Results First Submitted: March 15, 2019
Results First Posted: June 25, 2019
Last Update Posted: July 16, 2019