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Procedure

Treatment for Neuropathic Pain

N/A

Recruiting

Led By Timothy Deer, MD

Research Sponsored by Saint Francis Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be willing and capable of giving informed consent

Be 18 years of age or older at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

Study Summary

This trial is collecting information to see how well a specific therapy called CL-SCS works for real patients dealing with chronic pain.

Who is the study for?

This trial is for adults over 18 with chronic, intractable pain of the trunk or limbs that hasn't improved after at least 6 months of treatment. Participants must have a high level of baseline pain and be able to follow study procedures. Pregnant or nursing individuals, those with certain medical conditions, psychological disorders, other active implantable devices, prior SCS experience, or who are in another clinical study cannot join.Check my eligibility

What is being tested?

The ULTRA trial is observing how well Evoke Closed-loop Spinal Cord Stimulation (CL-SCS) therapy works on people with chronic pain in real-world settings. It's not testing against another treatment but looking at patient outcomes after receiving this specific intervention.See study design

What are the potential side effects?

While the side effects aren't specified here since it's an observational study of real-world use, typical SCS-related side effects can include infection risk at the implant site, discomfort or problems due to device presence like tingling sensations from nerve stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to agree to participate in the study.

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I am 18 years old or older.

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I have had severe, ongoing pain in my body for over 6 months that hasn't improved with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

VAS - Visual Analog Scale

Secondary outcome measures

PROMIS-29

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Saint Francis HospitalLead Sponsor

2 Previous Clinical Trials

30 Total Patients Enrolled

Saluda Medical Americas, Inc.Industry Sponsor

1 Previous Clinical Trials

134 Total Patients Enrolled

Timothy Deer, MDPrincipal InvestigatorSpine and Nerve Center of Saint Francis Hospital

1 Previous Clinical Trials

173 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being selected for enrollment in this clinical trial?

"Indeed, as per clinicaltrials.gov data, this research is presently enrolling volunteers. The trial was initially shared on January 30th, 2024 and the latest revision took place on February 6th of the same year. The study aims to recruit a total of 25 participants from one designated site."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"Indeed, information from clinicaltrials.gov reveals that this investigation is actively seeking suitable participants. The trial was initially listed on the 30th of January, 2024 and its most recent update was made on the 6th of February, 2024. There is a requirement for 25 patients to be recruited at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).

2024. "Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06246526.

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