Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870124
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-25
First Post:
2023-05-01
Brief Title:
Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain COMFORT 2
Sponsor:
Nalu Medical Inc
Organization:
Nalu Medical Inc
Study Overview
Official Title:
Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain COMFORT 2
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
COMFORT 2
Brief Summary:
This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic intractable peripheral neuralgia of post-traumatic or postsurgical origin This is a prospective minimal risk multi-center randomized control trial
Detailed Description:
Multi-center prospective open-label randomized controlled trial RCT comparing PNS plus CMM with CMM alone Subjects will be randomized to receive
Arm 1 Nalu Neurostimulation System for PNS plus CMM Arm 2 CMM alone Consented subjects will receive a baseline evaluation and then be randomized 21 into one of two arms 1 PNSCMM arm or 2 CMM arm Subjects assigned to Arm 1 will undergo a trial implant period using best clinical practices Those subjects who pass the trial implant will receive the permanent implant At the 3-month end point subjects in Arm 2 will be given the option to crossover into Arm 1 beginning with a trial implant All Arm 1 patients receiving a permanent implant will be followed for a total of 12 months after permanent implantationArm 2 patients who do not crossover will be followed for a total of 12 months from randomization
Arm 1 Nalu Neurostimulation System for PNS plus CMM Arm 2 CMM alone Consented subjects will receive a baseline evaluation and then be randomized 21 into one of two arms 1 PNSCMM arm or 2 CMM arm Subjects assigned to Arm 1 will undergo a trial implant period using best clinical practices Those subjects who pass the trial implant will receive the permanent implant At the 3-month end point subjects in Arm 2 will be given the option to crossover into Arm 1 beginning with a trial implant All Arm 1 patients receiving a permanent implant will be followed for a total of 12 months after permanent implantationArm 2 patients who do not crossover will be followed for a total of 12 months from randomization
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