Patient Retrospective Outcomes (PRO)

Boston Scientific

Status: Enrolling

Conditions: Chronic Pain

Treatments: Device: Boston Scientific Systems; Device: Non Boston Scientific Systems

Study type: Observational

Funder types: Industry

Identifiers

NCT01550575

A7005

Details and patient eligibility

About

This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

Full description

This study is a retrospective, multi-center, de-identified patient data review.

The study will include multiple independent cohorts to evaluate clinical outcomes in different subgroups.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Previously treated with or eligible for use with Boston Scientific Systems
• 18 years of age or older at the start of Baseline

Trial design

15,000 participants in 2 patient groups

Patients eligible for SCS, RF or other treatment approaches

Description:

Patients who have previously been implanted with, or are eligible for implantation with a spinal cord stimulation system or various other treatment approaches such as RF, IDS, etc.

Treatment:

Device: Non Boston Scientific Systems

Device: Boston Scientific Systems

Patients Eligible for treatment options with prior treatment

Description:

Patients who have previously been implanted with a spinal cord stimulation system or other various treatments, and have thereafter received a different form of chronic pain treatment such as a different SCS system, RF, IDS etc.

Treatment:

Device: Non Boston Scientific Systems

Device: Boston Scientific Systems