A DirEct to PatieNt Study in Chronic Pain (ENLITEN)

May 12, 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

  • United States
    • California
      • Valencia, California, United States, 91355
        • Boston Scientific Neuromodulation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain post procedure
Time Frame: up to 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

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 11, 2026

Study Completion (Actual)

May 11, 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)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 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.

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