NCT04466111

Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain

A Post-Market, Observational Clinical Study to Evaluate the Effects of Differential Target Multiplexed DTM™ SCS Programming in Treating Intractable Chronic Upper Extremity Limb Pain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 58 (actual)
• Sponsor: SGX Procura LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach. Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

Detailed description

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach. Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study. The expected total duration of this study is approximately 26 months. Enrollment of participants is expected to last 20 months. Participants that have received the permanent implant will be followed up for 12 months after their device has been activated. A participant will likely be committed to the study for about 14 months. This consists of Baseline assessments, up to 10 days of trial stimulation, and 12 months of treatment following implantation and activation of the device. All subjects who plan on remaining implanted through the 6-month visit or who have completed their 6-month visit will be offered to return for an additional 12-month visit. This would increase their commitment to the study to 14 months.

Conditions

• Upper Limb
• Pain

Interventions

Type	Name	Description
DEVICE	Intellis neurostimulator system	The study will use the commercially available IntellisTM neurostimulator and compatible SCS system components from Medtronic using stimulation parameters within the specifications approved for use in the approved indications. The study will stimulate the cervical dorsal columns of the spinal cord.

Timeline

• Start date: 2020-09-08
• Primary completion: 2022-07-29
• Completion: 2023-03-09
• First posted: 2020-07-10
• Last updated: 2024-08-19
• Results posted: 2024-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study