Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain — PROC2020PM  

Pain Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pain
• Upper Limb

• NCT number: NCT04466111
• Study type: Observational
• Source: SGX Medical LLC
• Status: Completed
• Start date: September 8, 2020
• Completion date: March 9, 2023