Trial Outcomes & Findings for BlueWind Medical Reprieve System for the Treatment of PNP (NCT NCT02062398)

Results Overview

The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

6 months

Results posted on

2019-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	The Reprieve System Implantation The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	The Reprieve System Implantation The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
Overall Study Implant removal	1

Baseline Characteristics

BlueWind Medical Reprieve System for the Treatment of PNP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Reprieve System Implantation n=13 Participants The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
Age, Continuous	59.7 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
pain measurement using Visual Analogue Scale	7.58 units on a scale STANDARD_DEVIATION 1.11 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period

Outcome measures

Outcome measures
Measure	The Reprieve System Implantation n=13 Participants The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).	1 Participants

PRIMARY outcome

Timeframe: 1 Month, 3 Months, and 6 months post system activation

Population: Out of the 13 treated patients, one device was explanted approximately after 3 weeks of treatment. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.

VAS score assessment at baseline and follow up visits was performed in two ways; 1. Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days. 2. Point VAS score- the analysis was based on the VAS score measurement recorded during the baseline visit and following 30 minutes stimulation at all follow up visits.Pain assessment by Visual Analogue Scale (VAS) as compared to baseline, post system activation. Visual Analogue Scale (VAS) for Pain Scores on a scale \[0 - 10\], higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	The Reprieve System Implantation n=12 Participants The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation Pain Diary VAS Score - 1M post system activation	3.94 score on a scale Standard Deviation 1.67
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation Pain Diary VAS score - 3M post system activation	3.75 score on a scale Standard Deviation 1.67
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation Pain Diary VAS Score - 6M post system activation	3.14 score on a scale Standard Deviation 1.52
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation Point VAS Score - 1M post system activation	3.38 score on a scale Standard Deviation 2.48
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation Point VAS score - 3M post system activation	2.79 score on a scale Standard Deviation 2.40
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation Point VAS Score - 6M post system activation	2.42 score on a scale Standard Deviation 2.61

SECONDARY outcome

Timeframe: 1 Month, 3 Months, and 6 months post system activation

Population: Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.

Clinical success at 6 months post activation was further assessed by:Short-form McGill pain questionnaire. McGill pain questionnaire Scores on a scale Range \[0-60\] points, higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	The Reprieve System Implantation n=12 Participants The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
Clinical Success 6 Months Post Activation McGill pain questionnaire - 1M post sys activation	14 score on a scale Standard Deviation 12.1
Clinical Success 6 Months Post Activation McGill pain questionnaire - 3M post sys activation	13.5 score on a scale Standard Deviation 13.4
Clinical Success 6 Months Post Activation McGill pain questionnaire - 6M post sys activation	12.3 score on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: 6 months post activation

Population: Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.

Clinical success is defined as the effect of the BlueWind Reprieve System on the treatment of the following symptoms compared to baseline: \- Pain related medication consumption/day

Outcome measures

Outcome measures
Measure	The Reprieve System Implantation n=12 Participants The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
Clinical Success 6 Months Post Activation not consumed any pain related medication	1 Participants
Clinical Success 6 Months Post Activation didn't change medication consumption	5 Participants
Clinical Success 6 Months Post Activation Reduction in medication consumption	6 Participants

SECONDARY outcome

Timeframe: 1 Month, 3 Months, and 6 months post system activation

Population: Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.

Clinical success was further assessed by: Quality of life questionnaire (SF-36 Health Survey) SF-36 Health Survey Scores on a scale \[0 - 100\], higher values represent a better outcome.

Outcome measures

Outcome measures
Measure	The Reprieve System Implantation n=12 Participants The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
Clinical Success 6 Months Post Activation SF-36 Health Survey - 1M post system activation	65.6 score on a scale Standard Error 5.2
Clinical Success 6 Months Post Activation SF-36 Health Survey - 3M post system activation	66.4 score on a scale Standard Error 5
Clinical Success 6 Months Post Activation SF-36 Health Survey - 6M post system activation	66.9 score on a scale Standard Error 4.2

Adverse Events

The Reprieve System Implantation

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	The Reprieve System Implantation n=13 participants at risk The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
Infections and infestations low grade infection and delayed closure of surgical wound	7.7% 1/13 • Number of events 1 • 6 Month

Other adverse events

Other adverse events
Measure	The Reprieve System Implantation n=13 participants at risk The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain
Infections and infestations infection	15.4% 2/13 • Number of events 2 • 6 Month
General disorders implant site discolouration	15.4% 2/13 • Number of events 2 • 6 Month
Skin and subcutaneous tissue disorders Skin irritatation	15.4% 2/13 • Number of events 2 • 6 Month

Additional Information

Amit Korner, VP Clinical Research

BlueWind Medical

Phone: +972.74.7218905

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Participating Institution and /or investigator may publish/present the results of the clinical investigation ("publication") only upon prior written consent provided by BlueWind Medical Ltd.
Publication restrictions are in place

Restriction type: OTHER