Radiofrequency (RF) Ablation Prospective Outcomes Study

NCT ID: NCT04673032

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-22

Study Completion Date

2025-02-07

Brief Summary

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The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems in the treatment of patients diagnosed with pain

Detailed Description

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Conditions

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Pain, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Boston Scientific Radiofrequency Ablation Systems

Subjects with pain treated with a commercially approved Boston Scientific RF system

Radiofrequency Ablation

Intervention Type DEVICE

Radiofrequency Ablation for treatment of chronic pain

Interventions

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Radiofrequency Ablation

Radiofrequency Ablation for treatment of chronic pain

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain per local Directions for Use (DFU)
* Signed a valid, IRB/EC/REB-approved informed consent form

Exclusion Criteria

* Meets any contraindications per locally applicable Directions for Use (DFU)
* Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Bloom Lyons, M.S.

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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Elite Pain and Spine Institute

Mesa, Arizona, United States

Site Status

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Site Status

The Spine Wellness Center in Westport

Westport, Connecticut, United States

Site Status

Shepherd Center

Atlanta, Georgia, United States

Site Status

Quincy Medical Group

Quincy, Illinois, United States

Site Status

Twin Cities Pain Clinic and Surgery Center

Edina, Minnesota, United States

Site Status

Carolinas Research Institute

Huntersville, North Carolina, United States

Site Status

UC Health Pain Medicine

Cincinnati, Ohio, United States

Site Status

Premier Pain Treatment Institute

Loveland, Ohio, United States

Site Status

Toledo Clinic

Toledo, Ohio, United States

Site Status

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, United States

Site Status

ZNA Hoge Beuken

Antwerp, , Belgium

Site Status

St. Jan

Bruges, , Belgium

Site Status

Mater Olbia Hospital

Olbia, , Italy

Site Status

St. Anna Hospital

Geldrop, , Netherlands

Site Status

Countries

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United States Belgium Italy Netherlands

References

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Provenzano DA, Holt B, Danko M, Atallah J, Iqbal M, Shah B, Singh A, Sachdeva H, Donck EV, Liebrand B, Shaw E, Haas S, Sekhar R, Pan A, Halperin DS, Goldberg E. Assessment of real-world, prospective outcomes in patients treated with cervical radiofrequency ablation for chronic pain (RAPID). Interv Pain Med. 2025 Aug 23;4(3):100623. doi: 10.1016/j.inpm.2025.100623. eCollection 2025 Sep.

Reference Type DERIVED
PMID: 40896553 (View on PubMed)

Provenzano DA, Holt B, Danko M, Atallah J, Iqbal M, Shah B, Singh A, Sachdeva H, Donck EV, Shaw E, Haas S, Sekhar R, Pan A, Halperin DS, Goldberg E. Assessment of real-world, prospective outcomes in patients treated with lumbar radiofrequency ablation for chronic pain (RAPID). Interv Pain Med. 2025 Apr 24;4(2):100576. doi: 10.1016/j.inpm.2025.100576. eCollection 2025 Jun.

Reference Type DERIVED
PMID: 40342788 (View on PubMed)

Other Identifiers

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A4087

Identifier Type: -

Identifier Source: org_study_id

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