Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413277
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-09
Brief Title:
Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain HOPE Trial
Sponsor:
Ainsworth Institute of Pain Management
Organization:
Ainsworth Institute of Pain Management
Study Overview
Official Title:
Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for the Treatment of Chronic Pelvic Pain HOPE Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None