A DirEct to PatieNt Study in Chronic Pain

Chronic Pain Clinical Trial

— ENLITEN  

Official title:

A DirEct to PatieNt Study in Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05515341
• Other study ID #: A4102
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: December 2029

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Alison Lewis
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Boston Scientific Neuromodulation	Valencia	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	Change in pain post procedure	Change in patient-reported pain on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain	up to 12 months