Trial Outcomes & Findings for Feasibility Study for Intrathoracic Nerve Stimulation (NCT NCT04066374)

Results Overview

Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2024-07-09

Participant milestones
Measure	Treatment Arm Intrathoracic placement of neurostimulation device Peripheral Nerve Stimulation: Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Feasibility Study for Intrathoracic Nerve Stimulation

Baseline characteristics by cohort
Measure	Treatment Arm n=10 Participants Intrathoracic placement of neurostimulation device Peripheral Nerve Stimulation: Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
Age, Continuous	65.8 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants
Baseline Pain Level	0 units on a scale n=5 Participants

Timeframe: Baseline to 3 months

Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome.

Outcome measures
Measure	Treatment Arm n=10 Participants Intrathoracic placement of neurostimulation device Peripheral Nerve Stimulation: Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
Pain as Measured by the Visual-analog Scale	1 units on a scale Interval 0.0 to 3.0

Timeframe: up to 7 days

Freedom from device related adverse events (i.e., bleeding, infection, pneumothorax or arrhythmias)

Outcome measures
Measure	Treatment Arm n=10 Participants Intrathoracic placement of neurostimulation device Peripheral Nerve Stimulation: Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
Freedom From Device Related Adverse Events Infection	1 Participants
Freedom From Device Related Adverse Events Bleeding	0 Participants
Freedom From Device Related Adverse Events Pneumothorax	1 Participants
Freedom From Device Related Adverse Events Arrhythmias	0 Participants

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events
Measure	Treatment Arm n=10 participants at risk Intrathoracic placement of neurostimulation device Peripheral Nerve Stimulation: Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	10.0% 1/10 • Number of events 1 • Time of procedure to 3-months post-op visit
Renal and urinary disorders Acute Kidney Injury	10.0% 1/10 • Number of events 1 • Time of procedure to 3-months post-op visit
Respiratory, thoracic and mediastinal disorders COPD	10.0% 1/10 • Number of events 1 • Time of procedure to 3-months post-op visit
Respiratory, thoracic and mediastinal disorders Pneumothorax	10.0% 1/10 • Number of events 2 • Time of procedure to 3-months post-op visit
Respiratory, thoracic and mediastinal disorders Emphysema	10.0% 1/10 • Number of events 1 • Time of procedure to 3-months post-op visit
Respiratory, thoracic and mediastinal disorders Pneumonia	10.0% 1/10 • Number of events 1 • Time of procedure to 3-months post-op visit

Other adverse events
Measure	Treatment Arm n=10 participants at risk Intrathoracic placement of neurostimulation device Peripheral Nerve Stimulation: Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
Gastrointestinal disorders Abdominal Pain	10.0% 1/10 • Number of events 1 • Time of procedure to 3-months post-op visit
General disorders Discomfort	30.0% 3/10 • Number of events 4 • Time of procedure to 3-months post-op visit
Respiratory, thoracic and mediastinal disorders Pleural Effusion	20.0% 2/10 • Number of events 2 • Time of procedure to 3-months post-op visit

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