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Observational Study of Saluda Evoke Smart SCS for Chronic Pelvic Pain

This study is looking at how well a device called the Saluda Evoke Smart SCS System works to treat chronic (long-lasting) pelvic pain, including pudendal neuralgia. This system uses a type of spinal cord stimulation (SCS) that targets a specific area in your lower spine called the conus medullaris. To join, you must be at least 18 years old and have severe chronic pelvic pain that hasn't improved with other treatments. The main goal is to see if the device can reduce your pelvic pain by at least 50% or 80% and improve your quality of life after 12 months. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an observational study where all participants receive the Saluda Evoke Smart SCS System. It is a single-center study, meaning it takes place at one location.
What's involved
You would undergo an implant procedure for the SCS system. Data will be collected at the start, during a trial phase, after the permanent implant, and at 3, 6, and 12 months post-implant.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 12 months after receiving the permanent implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06413277

Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial

Recruiting
Not specifiedAges 18+Observational
Ainsworth Institute of Pain Management
~20 participants
Updated 2024-05-14 on ClinicalTrials.gov
What's tested:Saluda Evoke Smart SCS System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy: Proportion of patients achieving at least 50% and 80% relief from pelvic pain and pelvic pain-related negative impact to quality of life compared to baseline
Measured over 12 months

Conditions

Chronic Pelvic Pain
Pudendal Neuralgia

Explore related trials

Pelvic PainProctalgia FugaxPudendal neuralgia

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Corey W Hunter, MD, FIPP · PRINCIPAL_INVESTIGATOR · Ainsworth Institute of Pain Management

Who to contact

Zoey Smith
[email protected]
(212) 203 2813
Email the study team

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What this trial measures

  • Efficacy: Proportion of patients achieving at least 50% and 80% relief from pelvic pain and pelvic pain-related negative impact to quality of life compared to baseline12 months

    Pelvic Pain Reduction will be evaluated using the Visual Analog Scale (VAS) by comparing baseline VAS Scores to 3-, 6-, and 12- month post ECAP CL-SCS Implant VAS Scores.