Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387244
Status:
TERMINATED
Last Update Posted:
2020-12-17
First Post:
2006-10-10
Brief Title:
Efficacy of the Spinal Cord Stimulation System as Salvage Therapy
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Efficacy of the Precision Spinal Cord Stimulation System as Salvage Therapy for Patients With Chronic Intractable Pain of the Trunk and or Limbs Who Have Failed Treatment With an Intraspinal Infusion Pump or Other Spinal Cord Stimulation Device
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient Data Collected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the efficacy of spinal cord stimulation using the Precision implantable neurostimulation device for chronic and intractable pain of the trunk and or limbs in patients who have failed treatment with an intraspinal infusion pump or other SCS system
Detailed Description:
Chronic pain is managed by the sequential application of various strategies medications anesthetic injections ablation surgery implantable intraspinal infusion pumps and spinal cord stimulation For a significant number of patients however these treatments are inadequate or cannot be tolerated Those patients require another option for pain relief
The therapy afforded by spinal cord stimulators is dependent on overlapping paresthesia with the painful areas One of the leading reasons for explant of SCS systems not including device failure or surgical complication is the complaint of inadequate pain relief due to poor coverage of the painful area Mounting evidence suggests that the clinical efficacy afforded by SCS varies with each manufacturers technology For instance previously-implanted SCS patients report more complete coverage better pain relief and a more pleasant sensation associated with the paresthesia of the Precision system The tight lead spacing and current fractionalization achievable with the Precision system may provide pain relief after failure with another SCS system
This study will assess pain relief with the Precision system for patients with chronic intractable pain who are refractory to treatment with other types of SCS systems andor implantable intraspinal infusion pumps Because Precision allows unique programming combinations not possible with other systems it is expected that subjects will enjoy significant pain relief
The therapy afforded by spinal cord stimulators is dependent on overlapping paresthesia with the painful areas One of the leading reasons for explant of SCS systems not including device failure or surgical complication is the complaint of inadequate pain relief due to poor coverage of the painful area Mounting evidence suggests that the clinical efficacy afforded by SCS varies with each manufacturers technology For instance previously-implanted SCS patients report more complete coverage better pain relief and a more pleasant sensation associated with the paresthesia of the Precision system The tight lead spacing and current fractionalization achievable with the Precision system may provide pain relief after failure with another SCS system
This study will assess pain relief with the Precision system for patients with chronic intractable pain who are refractory to treatment with other types of SCS systems andor implantable intraspinal infusion pumps Because Precision allows unique programming combinations not possible with other systems it is expected that subjects will enjoy significant pain relief
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None