Chronic PainENLITENNCT05515341
A DirEct to PatieNt Study in Chronic Pain
An observational study of Chronic Pain, run by Boston Scientific Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Commercially Approved Interventional Medical Device/Therapy for Chronic Pain
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 20 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Chronic pain
Who may be able to join
- 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
Who cannot join
- Requires a legal representative to sign the ICF ascertained from self-reporting
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Scientific Neuromodulation
Valencia, California, 91355
About this study
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.
- Conditions
- Chronic Pain
- Being tested
- Commercially Approved Interventional Medical Device/Therapy for Chronic Pain
- Keywords
- Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially Approved Interventional Medical Device/Therapy for Chronic PainDevice
Commercially Approved Interventional Medical Device/Therapy
| Study group | Role | What they receive |
|---|---|---|
| Medical Device Therapy/Procedure for Chronic Pain | Not described Receives: Device: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted Pain Responder Rate
Percentage of subjects with a 50 percent or greater reduction in targeted pain intensity, based on self-reported percent pain relief
Measured: up to 40 months post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start10 Jan 2023
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie B Lyons, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515341
- Sponsor's protocol ID
- A4102
- Acronym
- ENLITEN
- Status last verified
- Jul 2026
- First submitted
- 23 Aug 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A DirEct to PatieNt Study in Chronic Pain
- ClinicalTrials.gov ID
- NCT05515341
- Acronym / sponsor ID
- ENLITEN / A4102
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Device Therapy/Procedure for Chronic Pain | – | Device: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic pain
Key inclusion criteria (3 listed)
- 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 (1 listed)
- Requires a legal representative to sign the ICF ascertained from self-reporting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercially Approved Interventional Medical Device/Therapy for Chronic PainCommercially Approved Interventional Medical Device/Therapy | Device | Medical Device Therapy/Procedure for Chronic Pain |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie B Lyons study director
Boston Scientific Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted Pain Responder Rate (time frame: up to 40 months post study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.