Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
NCT ID: NCT06413277
Last Updated: 2024-05-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
20 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-02-05
Study Completion Date
2027-01-01
Brief Summary
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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).
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Detailed Description
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Primary Objective Evaluate the efficacy of ECAP CL-SCS in treating chronic pelvic pain.
Secondary Objectives Evaluate changes in impact of pain on activities of daily living, pain quality, quality of life, sleep, anxiety and depression, pain catastrophizing, patient satisfaction, and symptoms related to urinary urgency frequency.
Evaluate safety of using ECAP-controlled CL-SCS in treating chronic pelvic pain. Summarize and evaluate device performance and typical programming parameters.
Study design This protocol describes an observational, prospective, single-arm, single center study. Eligible subjects will undergo an implant procedure as per standard of care for SCS. The system will be used within its licensed use. Data will be collected prospectively from 1 US study center. Time points of data collection are at baseline, trial, device implant and at 3-, 6-, -12 months post-implant.
Study population Subjects with chronic, intractable pelvic pain will be screened for participation in this study.
Subjects who provide informed consent and meet the study eligibility criteria will be enrolled and will undergo a trial procedure.
Following the trial phase subjects may receive a permanent implant and be followed up at 3-, 6-, and 12-months following the permanent implant.
Enrollment will continue until 15 subjects receive a permanent implant. We estimate that up to 20 subjects will be enrolled in this study.
Statistical analyses will be conducted using an appropriate software package (e.g., SAS, SPSS, R, Statistics). Standard summary statistics will be used to summarize endpoints and key study variables. Categorical variables, including the incidence of adverse events, will be summarized via counts and percentages. Continuous variables will be summarized via mean, median, standard deviation, and range. 95% confidence intervals will also be included with summary statistics for primary and secondary endpoints as well as other variables where appropriate. Any p-values for secondary or other endpoints will be nominal and not adjusted for multiplicity.
Secondary Objectives Evaluate changes in impact of pain on activities of daily living, pain quality, quality of life, sleep, anxiety and depression, pain catastrophizing, patient satisfaction, and symptoms related to urinary urgency frequency.
Evaluate safety of using ECAP-controlled CL-SCS in treating chronic pelvic pain. Summarize and evaluate device performance and typical programming parameters.
Study design This protocol describes an observational, prospective, single-arm, single center study. Eligible subjects will undergo an implant procedure as per standard of care for SCS. The system will be used within its licensed use. Data will be collected prospectively from 1 US study center. Time points of data collection are at baseline, trial, device implant and at 3-, 6-, -12 months post-implant.
Study population Subjects with chronic, intractable pelvic pain will be screened for participation in this study.
Subjects who provide informed consent and meet the study eligibility criteria will be enrolled and will undergo a trial procedure.
Following the trial phase subjects may receive a permanent implant and be followed up at 3-, 6-, and 12-months following the permanent implant.
Enrollment will continue until 15 subjects receive a permanent implant. We estimate that up to 20 subjects will be enrolled in this study.
Statistical analyses will be conducted using an appropriate software package (e.g., SAS, SPSS, R, Statistics). Standard summary statistics will be used to summarize endpoints and key study variables. Categorical variables, including the incidence of adverse events, will be summarized via counts and percentages. Continuous variables will be summarized via mean, median, standard deviation, and range. 95% confidence intervals will also be included with summary statistics for primary and secondary endpoints as well as other variables where appropriate. Any p-values for secondary or other endpoints will be nominal and not adjusted for multiplicity.
Conditions
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Chronic Pelvic Pain
Pudendal Neuralgia
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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Saluda Evoke Smart SCS System
Surgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. Subject is 18 years of age or older at the time of enrollment.
2. Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm pain) at baseline.
3. Subject has been diagnosed with chronic intractable pain of the trunk and/or limbs specifically related to pelvic/genital/perineal/anorectal pain, which has been refractory to conservative therapy for a minimum of 6 months.
4. Subject has pain resulting from a known injury (surgery or trauma).
5. Subject has been clinically diagnosed with chronic pelvic pain (pain that occurs in the region of the pelvis), including diagnoses such as, but not limited to, complex regional pain syndrome (CRPS types 1 and 2), postsurgical pain, post-traumatic injury pain, interstitial cystitis/painful bladder syndrome, post-hysterectomy pain, post-prostatectomy pain, vulvodynia, chronic ovarian pain, and pudendal neuralgia of a known cause.
6. Subject is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
7. Subject is willing and capable of giving informed consent.
8. Subject is willing and able to comply with study-related requirements, procedures, and visits.
2. Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm pain) at baseline.
3. Subject has been diagnosed with chronic intractable pain of the trunk and/or limbs specifically related to pelvic/genital/perineal/anorectal pain, which has been refractory to conservative therapy for a minimum of 6 months.
4. Subject has pain resulting from a known injury (surgery or trauma).
5. Subject has been clinically diagnosed with chronic pelvic pain (pain that occurs in the region of the pelvis), including diagnoses such as, but not limited to, complex regional pain syndrome (CRPS types 1 and 2), postsurgical pain, post-traumatic injury pain, interstitial cystitis/painful bladder syndrome, post-hysterectomy pain, post-prostatectomy pain, vulvodynia, chronic ovarian pain, and pudendal neuralgia of a known cause.
6. Subject is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
7. Subject is willing and capable of giving informed consent.
8. Subject is willing and able to comply with study-related requirements, procedures, and visits.
Exclusion Criteria
1. Subject is pregnant or nursing.
2. Subject is involved in a malignancy or injury claim under current litigation or has pending/approved worker's compensation claim.
3. Subject's mechanism of pain is unknown.
4. Suspected cause and onset of pain are more than 30 days apart.
5. Subject has history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, CRPS in secondary pain area, and/or atypical facial pain.
6. Subject has been diagnosed with Crohn's Disease, Irritable Bowel Syndrome, ulcerous colitis, or any other inflammatory disease that is ongoing.
7. Subject has a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.
8. Subject has a history of sexual abuse and/or sexual trauma.
9. Subject has a history of unmanaged depression or anxiety that pre-dates the onset of symptoms.
10. Subject is using greater than 100 MME (morphine milligram equivalents) of opioids at baseline.
11. Subject shows evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
12. Subject has previous neuromodulation experience including SCS (Spinal Cord Stimulator) and/or DRG (Dorsal Root Ganglion).
13. Subject has an existing drug pump and/or SCS system, or another active implantable device such as a pacemaker, deep brain stimulator, or sacral nerve stimulator.
14. Subject is concomitantly participating in another clinical study.
2. Subject is involved in a malignancy or injury claim under current litigation or has pending/approved worker's compensation claim.
3. Subject's mechanism of pain is unknown.
4. Suspected cause and onset of pain are more than 30 days apart.
5. Subject has history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, CRPS in secondary pain area, and/or atypical facial pain.
6. Subject has been diagnosed with Crohn's Disease, Irritable Bowel Syndrome, ulcerous colitis, or any other inflammatory disease that is ongoing.
7. Subject has a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.
8. Subject has a history of sexual abuse and/or sexual trauma.
9. Subject has a history of unmanaged depression or anxiety that pre-dates the onset of symptoms.
10. Subject is using greater than 100 MME (morphine milligram equivalents) of opioids at baseline.
11. Subject shows evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
12. Subject has previous neuromodulation experience including SCS (Spinal Cord Stimulator) and/or DRG (Dorsal Root Ganglion).
13. Subject has an existing drug pump and/or SCS system, or another active implantable device such as a pacemaker, deep brain stimulator, or sacral nerve stimulator.
14. Subject is concomitantly participating in another clinical study.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Saluda Medical Pty Ltd
INDUSTRY
Sponsor Role
collaborator
Ainsworth Institute of Pain Management
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Corey W Hunter, MD, FIPP
Role: PRINCIPAL_INVESTIGATOR
Ainsworth Institute of Pain Management
Locations
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Ainsworth Institute of Pain Management
New York, New York, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Mekhail NA, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Pope JE, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, McJunkin T, Carlson J, Kim CK, Yang MI, Stauss T, Petersen EA, Hagedorn JM, Rauck R, Kallewaard JW, Baranidharan G, Taylor RS, Poree L, Brounstein D, Duarte RV, Gmel GE, Gorman R, Gould I, Hanson E, Karantonis DM, Khurram A, Leitner A, Mugan D, Obradovic M, Ouyang Z, Parker J, Single P, Soliday N; EVOKE Study Group. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. 2024 May 7;49(5):346-354. doi: 10.1136/rapm-2023-104751.
Reference Type
BACKGROUND
Other Identifiers
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1351927
Identifier Type: -
Identifier Source: org_study_id
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