Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
NCT06413277 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20
Last updated 2024-05-14
Summary
The aim of the study is to evaluate the effectiveness of using ECAP (electrically evoked compound action potential)-controlled CL (closed-loop) SCS (spinal cord stimulation) to treat chronic pelvic pain by stimulating an area in the spine called the conus medullaris (the lowermost tapering extremity of the spinal cord).
Conditions
- Chronic Pelvic Pain
- Pudendal Neuralgia
Interventions
- DEVICE
-
Saluda Evoke Smart SCS System
Surgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation
Sponsors & Collaborators
-
Saluda Medical Pty Ltd
collaborator INDUSTRY -
Ainsworth Institute of Pain Management
lead OTHER
Principal Investigators
-
Corey W Hunter, MD, FIPP · Ainsworth Institute of Pain Management
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-05
- Primary Completion
- 2026-01-01
- Completion
- 2027-01-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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