An interventional study of Resolve Stimulator and Proximity Lead in Asthma, sponsored by ElectroCore INC. Completed at 6 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-15.
Sponsored by ElectroCore INC · Not applicable, Interventional, and Treatment
The goal of this study is to validate design for the Resolve™ Stimulator and Proximity Electrode and the associated procedure to quickly and safely place an electrode into the neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm that the electrical signal being delivered via this electrode rapidly counters bronchoconstriction and improves airway flow.
The present study is to evaluate the safety of a new neurostimulator device, the Resolve Stimulator and Proximity Lead™, which comprises an external electrical signal generator coupled to temporary electrode that is percutaneously inserted in the neck.
Sponsor believes, based on animal testing data provided as well as consultations with physicians who regularly treat patients suffering from attacks of acute bronchoconstriction in ER and inpatient hospital settings, that this device could be used in the skilled care hospital setting to help rapidly relax the smooth muscle in the airway, relieving a clinically significant portion of the bronchoconstriction suffered by patients experiencing moderate to severe asthma attacks, allowing more effective delivery of inhaled medications to restore the patient to his or her baseline respiration status.
ElectroCore INC is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
At risk of imminent respiratory collapse
An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment
Device: Resolve Stimulator and Proximity Lead
An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation
Safety- Number of Participants With Adverse Events
Safety- Number of participants that reported Adverse Events
Time frame: 2 weeks
Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).
An assessment of Forced Expiry Volume in 1second (FEV1) measurements were taken throughout the course of treatment (15,30 and 60 minutes). Peak FEV1 measurements were recorded for each subject, and the number of minutes the subject had received treatment at the time of peak FEV1. The threshold for improvement was set at 12% over baseline at any of the time points (15,30 and 60 minutes). Outcome measure data indicates the number of subjects above 12%.
Time frame: 60 minutes
| Milestone | Resolve Stimulator and Proximity Lead |
|---|---|
| Started | 25 |
| Completed | 23 |
| Not completed | 2 |
Safety- Number of participants that reported Adverse Events
| Participants | Resolve Stimulator and Proximity Lead |
|---|---|
| Safety- Number of Participants With Adverse Events | 16 |
An assessment of Forced Expiry Volume in 1second (FEV1) measurements were taken throughout the course of treatment (15,30 and 60 minutes). Peak FEV1 measurements were recorded for each subject, and the number of minutes the subject had received treatment at the time of peak FEV1. The threshold for improvement was set at 12% over baseline at any of the time points (15,30 and 60 minutes). Outcome measure data indicates the number of subjects above 12%.
| Participants | Resolve Stimulator and Proximity Lead |
|---|---|
| Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1). | 19 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Resolve Stimulator and Proximity Lead | 1/25 (4%) | 11/25 (44%) | 8/25 (32%) |
| Event | Resolve Stimulator and Proximity Lead |
|---|---|
| Hospitalization for asthma exacerbationRespiratory, thoracic and mediastinal disorders | 4/25 |
| Hospitalization for persistant asthma symptomsRespiratory, thoracic and mediastinal disorders | 2/25 |
| Hospitalization for chest pain associated with cocaine useRespiratory, thoracic and mediastinal disorders | 1/25 |
| Death at 15 days post treatmentRespiratory, thoracic and mediastinal disorders | 1/25 |
| Hospitalization for observation; respiratoryRespiratory, thoracic and mediastinal disorders | 1/25 |
| Hospitalization for pneumoniaRespiratory, thoracic and mediastinal disorders | 1/25 |
| Hospitalization for continuation of asthma exacerbationReproductive system and breast disorders | 1/25 |
| Event | Resolve Stimulator and Proximity Lead |
|---|---|
| Muscle twitching in neckMusculoskeletal and connective tissue disorders | 3/25 |
| Sweating during attempted lead advancementEndocrine disorders | 1/25 |
| Lead displacementSurgical and medical procedures | 1/25 |
| Neck pain for 2 days post treatmentMusculoskeletal and connective tissue disorders | 1/25 |
| HematomaVascular disorders | 1/25 |
| Bleeding at insertion siteVascular disorders | 1/25 |
| Asthma exacerbationRespiratory, thoracic and mediastinal disorders | 1/25 |
Safety population
| Age, Continuous(years) | Resolve Stimulator and Proximity Lead |
|---|---|
| Mean | 41 (19 to 65) |
| Sex: Female, Male(Participants) | Resolve Stimulator and Proximity Lead |
|---|---|
| Female | 16 |
| Male | 9 |
| Race/Ethnicity, Customized(Participants) | Resolve Stimulator and Proximity Lead |
|---|---|
| Black | 18 |
| Hispanic and white | 1 |
| American Indian or Alaska Native | 1 |
| White | 2 |
| Other | 1 |
| Hispanic Latino | 1 |
| Hispanic Black | 1 |
| Region of Enrollment(Participants) | Resolve Stimulator and Proximity Lead |
|---|---|
| United States | 25 |
Plan to share: No
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ElectroCore INC