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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06413277 on ClinicalTrials.gov