A DirEct to PatieNt Study in Chronic Pain (ENLITEN)

Boston Scientific

Status: Enrolling

Conditions: Chronic Pain

Treatments: Device: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain

Study type: Observational

Funder types: Industry

Identifiers

NCT05515341

A4102

Details and patient eligibility

About

To compile real-world, direct from patient clinical outcomes and objective metrics in patients who have received or plan to receive a commercially approved interventional medical device therapy/procedure for chronic pain in routine clinical practice.

Enrollment: 50,000 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Patient is planning to receive or has received a commercially approved interventional medical device therapy/procedure to treat chronic pain, ascertained from self-reporting
• Age ≥ 22 years at time of eligibility screening, ascertained by self-reported age at time of eligibility screening
• Proficient in written and spoken English, defined by self-reporting of comfort reading, writing and speaking English

Key Exclusion Criteria:

• Requires a legal representative to sign the ICF ascertained from self-reporting

Trial design

50,000 participants in 1 patient group

Medical Device Therapy/Procedure for Chronic Pain

Treatment:

Device: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain