NCT03756012

Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Kettering Health Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of pulse widths \<500 μsec and \>1000 μsec on clinical outcomes during a temporary SCS trial.

Detailed description

The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include up to 10 subjects in the study per site. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algovita® system with percutaneous leads. Each subject will be followed during the trial period of approximately 7+/-2 days. The study will end when the last subject has completed the trial period and exited. The expected enrollment period for this study is approximately six months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.

Conditions

• Back Pain
• Pain

Interventions

Type	Name	Description
DEVICE	Algovita Spinal Cord Stimulation System	The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

Timeline

• Start date: 2018-11-27
• Primary completion: 2019-10-02
• Completion: 2019-10-02
• First posted: 2018-11-28
• Last updated: 2021-03-08
• Results posted: 2021-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study