ENLITEN: A DirEct to PatieNt Study in Chronic Pain

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05515341
• Collaborator: (none)
• Enrollment: 50,000
• Anticipated Duration (Months): 75.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A DirEct to PatieNt Study in Chronic Pain
• Anticipated Study Start Date: Aug 22, 2022
• Anticipated Primary Completion Date: Dec 1, 2028
• Anticipated Study Completion Date: Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Medical Device Therapy/Procedure for Chronic Pain	Device: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain; Spinal Cord Stimulation for the treatment of Chronic pain

Outcome Measures

Primary Outcome Measures

1. Change in pain post procedure [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Natalie B Lyons, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT05515341
• Other Study ID Numbers: A4102
• First Posted: Aug 25, 2022
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• 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
• Keywords provided by Boston Scientific Corporation: Spinal Cord Stimulation, Chronic Pain
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Aug 25, 2022