Trial Outcomes & Findings for Electrical Nerve Block for Amputation Pain (NCT NCT02221934)
NCT ID: NCT02221934
Last Updated: 2025-06-06
Results Overview
Demonstration of 50% reduction in a Numerical Rating Scale (NRS; 0-10 Scale; with 10 being the highest pain imaginable) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
607 participants
Primary outcome timeframe
Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)
Results posted on
2025-06-06
Participant Flow
Subjects were required to fulfill all eligibility requirements, including lidocaine injection screening. Eligible subjects underwent study device implant and activation prior to group assignment.
Participant milestones
| Measure |
Test Treatment
Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
|
Active Sham Control Treatment
Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
|
Not Yet Randomized
Not yet randomized to Test Treatment or Active Sham Control Treatment groups.
|
|---|---|---|---|
|
Screening
STARTED
|
0
|
0
|
607
|
|
Screening
COMPLETED
|
0
|
0
|
183
|
|
Screening
NOT COMPLETED
|
0
|
0
|
424
|
|
Device Activation
STARTED
|
0
|
0
|
183
|
|
Device Activation
Primary Safety Analysis Cohort
|
0
|
0
|
183
|
|
Device Activation
Successful Implant
|
0
|
0
|
180
|
|
Device Activation
COMPLETED
|
0
|
0
|
178
|
|
Device Activation
NOT COMPLETED
|
0
|
0
|
5
|
|
Randomized Testing (Month 1 to Month 3)
STARTED
|
87
|
91
|
0
|
|
Randomized Testing (Month 1 to Month 3)
Successful Randomization
|
87
|
91
|
0
|
|
Randomized Testing (Month 1 to Month 3)
Successful Device Use (Primary Effectiveness Analysis Cohort)
|
85
|
85
|
0
|
|
Randomized Testing (Month 1 to Month 3)
COMPLETED
|
82
|
83
|
0
|
|
Randomized Testing (Month 1 to Month 3)
NOT COMPLETED
|
5
|
8
|
0
|
|
Follow-up (Month 3 to Month 12)
STARTED
|
82
|
83
|
0
|
|
Follow-up (Month 3 to Month 12)
COMPLETED
|
74
|
75
|
0
|
|
Follow-up (Month 3 to Month 12)
NOT COMPLETED
|
8
|
8
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrical Nerve Block for Amputation Pain
Baseline characteristics by cohort
| Measure |
Test Treatment
n=85 Participants
Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
|
Active Sham Control Treatment
n=85 Participants
Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 12.21 • n=99 Participants
|
57.9 years
STANDARD_DEVIATION 12.57 • n=107 Participants
|
58.0 years
STANDARD_DEVIATION 12.35 • n=206 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Level of Amputation
Above knee (AKA)
|
38 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Level of Amputation
Below knee (BKA)
|
47 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)Demonstration of 50% reduction in a Numerical Rating Scale (NRS; 0-10 Scale; with 10 being the highest pain imaginable) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).
Outcome measures
| Measure |
Test Treatment
n=85 Participants
Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
|
Active Sham Control Treatment
n=85 Participants
Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
|
|---|---|---|
|
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
|
21 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From screening injection visit through 3 months post implantIncidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.
Outcome measures
| Measure |
Test Treatment
n=85 Participants
Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
|
Active Sham Control Treatment
n=85 Participants
Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
|
|---|---|---|
|
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
All Serious Adverse Events (SAE)
|
24 Participants
|
19 Participants
|
|
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
Serious Adverse Device Effect (SADE)
|
3 Participants
|
5 Participants
|
|
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
Unanticipated Adverse Device Effect (UADE)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post implantAverage percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months post implantAverage morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months post implantBrief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months post implantEQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months post implantComparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months post implantIncidence of all Non-Serious Adverse Events, including Non-Serious Adverse Events, Non-Serious Adverse Device Events, and Unanticipated (Non-Serious) Adverse Device Events from the time of consent through 12 months post implant.
Outcome measures
Outcome data not reported
Adverse Events
Test Treatment
Serious events: 35 serious events
Other events: 34 other events
Deaths: 1 deaths
Active Sham Control Treatment
Serious events: 35 serious events
Other events: 34 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Test Treatment
n=85 participants at risk
Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
|
Active Sham Control Treatment
n=85 participants at risk
Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
2.4%
2/85 • Number of events 2 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.4%
2/85 • Number of events 2 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Gastrointestinal disorders
Haematemesis
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
General disorders
Adverse drug reaction
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
General disorders
Discomfort
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
General disorders
Implant site necrosis
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
General disorders
Medical device discomfort
|
4.7%
4/85 • Number of events 4 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
General disorders
Medical device site discomfort
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
General disorders
Medical device site pain
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
2.4%
2/85 • Number of events 2 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Abscess
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Appendicitis
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Cellulitis
|
2.4%
2/85 • Number of events 3 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
2.4%
2/85 • Number of events 2 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Implant site cellulitis
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Implant site infection
|
3.5%
3/85 • Number of events 4 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
3.5%
3/85 • Number of events 4 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Postoperative wound infection
|
2.4%
2/85 • Number of events 3 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
3.5%
3/85 • Number of events 3 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Rotavirus infection
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Shunt infection
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Wound infection
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
2.4%
2/85 • Number of events 2 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
2.4%
2/85 • Number of events 2 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Procedural complication
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.4%
2/85 • Number of events 2 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
2/85 • Number of events 2 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Calcifying fibrous pseudotumour
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteosarcoma metastatic
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Nervous system disorders
Amputation stump pain
|
2.4%
2/85 • Number of events 3 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Nervous system disorders
Toxic encephalopathy
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Product Issues
Device extrusion
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Psychiatric disorders
Major depression
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Psychiatric disorders
Mental status changes
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Renal and urinary disorders
Dysuria
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
2.4%
2/85 • Number of events 2 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Surgical and medical procedures
Amputation
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Surgical and medical procedures
Knee operation
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Vascular disorders
Haematoma
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Vascular disorders
Thrombosis
|
0.00%
0/85 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
Other adverse events
| Measure |
Test Treatment
n=85 participants at risk
Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
|
Active Sham Control Treatment
n=85 participants at risk
Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
|
|---|---|---|
|
General disorders
Medical device discomfort
|
5.9%
5/85 • Number of events 5 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
5.9%
5/85 • Number of events 5 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
22.4%
19/85 • Number of events 38 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
21.2%
18/85 • Number of events 28 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Corona virus infection
|
4.7%
4/85 • Number of events 4 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
5.9%
5/85 • Number of events 5 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Infections and infestations
Postoperative wound infection
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
5.9%
5/85 • Number of events 5 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
5/85 • Number of events 5 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
1.2%
1/85 • Number of events 1 • From time of lidocaine injection screening through Month-12, approximately 1 year
|
Additional Information
Nick Hargus, PhD. Vice President of Clinical and Medical Affairs
Neuros Medical, Inc.
Phone: 440-951-2565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place