Trial Outcomes & Findings for Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System (NCT NCT03251937)

NCT ID: NCT03251937

Last Updated: 2021-04-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 97 participants
• Primary outcome timeframe: 3 months post activation
• Results posted on: 2021-04-01

Participant Flow

Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and proceed in the study.

Participant milestones

Measure	Spinal Cord Stimulation Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy
Overall Study STARTED	40
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System

Baseline characteristics by cohort

Measure	Spinal Cord Stimulation n=40 Participants Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy
Age, Continuous	63.2 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post activation

Outcome measures

Measure	Spinal Cord Stimulation n=40 Participants Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline	31 Participants

Adverse Events

Spinal Cord Stimulation

Serious events: 7 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Spinal Cord Stimulation n=97 participants at risk Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy
Cardiac disorders Angina	1.0% 1/97 • Number of events 1 • Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
Cardiac disorders Myocardial Infarction	1.0% 1/97 • Number of events 1 • Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
Cardiac disorders Sinus Node Dysfunction	1.0% 1/97 • Number of events 1 • Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
Musculoskeletal and connective tissue disorders Back Pain	1.0% 1/97 • Number of events 1 • Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.0% 1/97 • Number of events 1 • Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
Musculoskeletal and connective tissue disorders Spondylolisthesis	1.0% 1/97 • Number of events 1 • Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
Nervous system disorders Cerebrovascular Accident	1.0% 1/97 • Number of events 1 • Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Sciences

Boston Scientific

Phone: 661 949 4350

Email: roshini.jain@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place