## Protocol Section
### Identification Module
**NCT ID:** NCT06413277

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

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

#### Organization Study ID Info
**ID:** 1351927
#### Organization
**Class:** OTHER
**Full Name:** Ainsworth Institute of Pain Management
### Status Module
#### Completion Date
**Date:** 2027-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-05

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-09
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Saluda Medical Pty Ltd

#### Lead Sponsor

**Class:** OTHER

**Name:** Ainsworth Institute of Pain Management

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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).

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Chronic Pelvic Pain

- Pudendal Neuralgia

**Keywords:**

- Chronic Pelvic Pain

- Pudendal Neuralgia

- Levator Ani Syndrome

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Surgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation

**Name:** Saluda Evoke Smart SCS System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

#### Secondary Outcomes

**Description:** Evaluate changes in impact of pain on activities of daily living from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pain Disability Index (PDI).

**Measure:** Impact of pain on activities of daily living: Proportion of patients achieving at least 50% and 80% reduction in impact of pain on activities of daily living compared to baseline.

**Time Frame:** 12 months

**Description:** Evaluate changes in Pain quality from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using the Short Form-McGill Pain Questionnaire-2 (SF-MPQ2).

**Measure:** Changes in Pain quality: Proportion of patients achieving at least 50% and 80% relief in regard to pain quality compared to baseline

**Time Frame:** 12 months

**Description:** Evaluate changes in health-related quality of life from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using EQ-5D-5L (The EuroQol 5 Dimension 5 Level self-report survey).

**Measure:** Changes in Health-Related Quality of life: Proportion of patients achieving at least 50% and 80% improvement in health-related quality of life compared to baseline.

**Time Frame:** 12 months

**Description:** Evaluate changes in sleep quality and disturbances from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pittsburgh Sleep Quality Index (PSQI) questionnaire.

**Measure:** Changes in sleep quality: Proportion of patients achieving at least 50% and 80% improvement in sleep quality compared to baseline.

**Time Frame:** 12 months

**Description:** Evaluate changes in Anxiety and Depression from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Hospital Anxiety and Depression Scale (HADS).

**Measure:** Changes in Anxiety and Depression: Proportion of patients achieving at least 50% and 80% reduction in anxiety and depression compared to baseline.

**Time Frame:** 12 months

**Description:** Evaluate changes in Pain Catastrophizing from baseline to at 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pain Catastrophizing Scale (PCS).

**Measure:** Changes in Pain Catastrophizing: Proportion of patients achieving at least 50% and 80% reduction in pain catastrophizing compared to baseline.

**Time Frame:** 12 months

**Description:** Evaluate changes in Global improvement with treatment at 3-, 6-, and 12-month post ECAP CL-SCS Implant using Patient global impression of change (PGIC) questionnaire.

**Measure:** Global Improvement: Proportion of patients achieving at least 50% and 80% increase in global improvement compared to baseline.

**Time Frame:** 12 months

**Description:** Evaluate changes in Urinary Urgency Frequency Patient Symptoms from baseline to 3-, 6-, and 12- month post ECAP CL-SCS Implant using Pelvic Pain and Urinary Urgency Frequency (PUF) Patient Symptom Scale.

**Measure:** Changes in Urinary Urgency Frequency: Proportion of patients achieving at least 50% and 80% reduction of urinary urgency frequency compared to baseline.

**Time Frame:** 12 months

**Description:** Evaluate safety of ECAP CL-SCS in treating chronic pelvic pain by analyzing the incidence of study-related adverse event (AE) and serious AE (SAE).

**Measure:** Safety of ECAP CL-SCS: Number of participants who experience study-related adverse events (AEs) and serious AEs (SAEs), the seriousness and severity of the AEs/SAEs and how the AEs/SAEs relate to procedure, device, and/or stimulation.

**Time Frame:** 12 months

**Description:** Device settings and data (e.g., ECAP target, amplitude, pulse width, frequency, programmed electrodes, recharge characteristics and patient usage) will be collected and summarized at the end of the study.

**Measure:** Optimal device settings: Device settings at which participants achieved at least 50% and 80% increase in global improvement compared to baseline.

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** 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.

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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients aged 18 or older with chronic, intractable pelvic pain

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zsmith@ainpain.com

**Name:** Zoey Smith

**Phone:** (212) 203 2813

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** zsmith@ainpain.com

- **Name:** Zoey Smith

- **Phone:** 212-203-2813

- **Role:** CONTACT

***Contact 2:***

- **Name:** Corey W Hunter, MD, FIPP

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Jeanmarie Tari, NP

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Ainsworth Institute of Pain Management

**State:** New York

**Status:** RECRUITING

**Zip:** 10022

#### Overall Officials

**Official 1:**

**Affiliation:** Ainsworth Institute of Pain Management

**Name:** Corey W Hunter, MD, FIPP

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009408

- Term: Nerve Compression Syndromes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12381

- Name: Neuralgia

- Relevance: HIGH

- As Found: Neuralgia

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M19918

- Name: Pelvic Pain

- Relevance: HIGH

- As Found: Pelvic Pain

- ID: M29660

- Name: Pudendal Neuralgia

- Relevance: HIGH

- As Found: Pudendal Neuralgia

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12352

- Name: Nerve Compression Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M5853

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18092

- Name: Hereditary Sensory and Motor Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

- ID: T4805

- Name: Pudendal Neuralgia

- Relevance: HIGH

- As Found: Pudendal Neuralgia

- ID: T3408

- Name: Levator Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: T1081

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: T2761

- Name: Hereditary Motor and Sensory Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: T2766

- Name: Hereditary Neuropathy With Liability to Pressure Palsies

- Relevance: LOW

- As Found: Unknown

- ID: T5067

- Name: Roussy Levy Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009437

- Term: Neuralgia

- ID: D000060545

- Term: Pudendal Neuralgia

- ID: D000017699

- Term: Pelvic Pain

### Misc Info Module

- Version Holder: 2024-05-31
