A DirEct to PatieNt Study in Chronic Pain (ENLITEN)
July 21, 2026 updated by: Boston Scientific Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
73
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Valencia, California, United States, 91355
- Boston Scientific Neuromodulation
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with Chronic pain
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Medical Device Therapy/Procedure for Chronic Pain
|
Commercially Approved Interventional Medical Device/Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Targeted Pain Responder Rate
Time Frame: up to 40 months post study enrollment
|
Percentage of subjects with a 50 percent or greater reduction in targeted pain intensity, based on self-reported percent pain relief
|
up to 40 months post study enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Natalie B Lyons, Boston Scientific Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2023
Primary Completion (Actual)
May 20, 2026
Study Completion (Actual)
May 20, 2026
Study Registration Dates
First Submitted
August 23, 2022
First Submitted That Met QC Criteria
August 23, 2022
First Posted (Actual)
August 25, 2022
Study Record Updates
Last Update Posted (Actual)
July 23, 2026
Last Update Submitted That Met QC Criteria
July 21, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.