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NCT02988713 Clinical Trial

Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial

Chronic Pain Clinical Trial

Official title:
Study to Characterize the Effects of Programming Spinal Cord Stimulation (SCS) in Patients Undergoing a Boston Scientific (BSC) SCS Temporary Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02988713
Other study ID # 91153461
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 13, 2016
Est. completion date December 2, 2020

Study information
Verified date April 2022
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date December 2, 2020
Est. primary completion date December 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU). - Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form. - Subject is 18 years of age or older when written informed consent is obtained. Key Exclusion Criteria: - Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Programming
Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Locations
Country Name City State
United States PCPMG Clinical Research Unit, LLC Greenville South Carolina
United States Pacific Pain Management, Inc. Ventura California

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Comfort Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable" An estimated average of 7 days post temporary trial procedure
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