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Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment
trial testing PneumRx Coil System in Emphysema in 20 participants. Terminated before completion.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 9 June 2015 |
| Primary completion | 8 December 2017 |
| Estimated completion | 20 October 2018 |
| Sites | 2 locations across Germany |
Boston Scientific Corporation — full company profile →
18 and older, any sex, with Emphysema. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 19.1 | ± 63.06 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 21.4 | ± 46.94 |
Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment |
|---|---|---|
| Chronic obstructive pulmonary disorder | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Condition aggravated | General disorders | — |
| Implant site reaction | General disorders | — |
| Anaphylactic reaction | Immune system disorders | — |
| Infective exacerbation of chronic obstructive pulmonary disorders | Infections and infestations | — |
| Post procedural pneumonia | Infections and infestations | — |
| Fibrocystic breast disease | Reproductive system and breast disorders | — |
| Reaction | System | Treatment |
|---|---|---|
| Chronic Obstructive Pulmonary Disorder | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory Tract Infection | Infections and infestations | — |
| Depression | Psychiatric disorders | — |
| Tendon Rupture | Injury, poisoning and procedural complications | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| General Physical Health Deterioration | General disorders | — |
| Infective Exacerbation of Chronic Obstructive Airways Disease | Infections and infestations | — |
| Nasopharyngitis | Infections and infestations | — |
| Pneumonia Bacterial | Infections and infestations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Chest Discomfort | General disorders | — |
| Mastectomy | Surgical and medical procedures | — |
| Herpes Zoster | Infections and infestations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Chronic obstructive pulmonary disorder, Dyspnoea, Pneumothorax, Condition aggravated, Implant site reaction, Anaphylactic reaction, Infective exacerbation of chronic obstructive pulmonary disorders, Post procedural pneumonia.
Data from ClinicalTrials.gov NCT02499380 adverse events section.
The objective of this post-marketing study is to advance the understanding of the mechanism of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac performance in patients with emphysema treated with the RePneu Coils, when used as intended.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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