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

Part of paid clinical trials in New York, New York.

Sponsor
Ainsworth Institute of Pain Management
Study ID
NCT06413277
Status
Recruiting
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Conditions

  • Chronic Pelvic Pain
  • Pudendal Neuralgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saluda Evoke Smart SCS System — DEVICE
    Surgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation

Study Details

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).

Key Dates

Start date
Feb 5, 2024
Status verified
May 2024
Primary completion
Jan 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
20 participants (estimated)

Primary Outcome Measure

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 [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ainsworth Institute of Pain ManagementNew YorkNew York10022
Zoey Smith
[email protected]
212-203-2813
Corey W Hunter, MD, FIPP (PRINCIPAL_INVESTIGATOR)
Jeanmarie Tari, NP (SUB_INVESTIGATOR)

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