Radiofrequency (RF) Ablation Prospective Outcomes Study

NCT04673032 | Completed Results FDA Device

• 1 other identifier: A4087
• Study Type: observational
• Target: 298
• Locations: 4 countries
• Sites: 15

Brief Summary

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

Conditions

Pain, Chronic

Keywords

Radiofrequency (RF)

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Change (PGIC)

  Using the Patient Global Impression of Change (PGIC) Scale, subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse compared with Baseline

  12-months post-procedure

Other Outcomes (1)

• Responder Rate

  12-months post-procedure

Study Arms (1)

Boston Scientific Radiofrequency Ablation Systems

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

Device: Radiofrequency Ablation

Interventions

Radiofrequency Ablation DEVICE

Radiofrequency Ablation for treatment of chronic pain

Boston Scientific Radiofrequency Ablation Systems

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Pain

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (15)

Elite Pain and Spine Institute

Mesa, Arizona, 85203, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

The Spine Wellness Center in Westport

Westport, Connecticut, 06880, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Quincy Medical Group

Quincy, Illinois, 62301, United States

Location

Twin Cities Pain Clinic and Surgery Center

Edina, Minnesota, 55439, United States

Location

Carolinas Research Institute

Huntersville, North Carolina, 28078, United States

Location

UC Health Pain Medicine

Cincinnati, Ohio, 45219, United States

Location

Premier Pain Treatment Institute

Loveland, Ohio, 45140, United States

Location

Toledo Clinic

Toledo, Ohio, 43623, United States

Location

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, 15143, United States

Location

ZNA Hoge Beuken

Antwerp, Belgium

Location

St. Jan

Bruges, Belgium

Location

Mater Olbia Hospital

Olbia, Italy

Location

St. Anna Hospital

Geldrop, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 40896553 DERIVED

• 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.

  PMID: 40342788 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Boston Scientific Corporation

BSNClinicalTrials@bsci.com

855-213-9890

Study Officials

• Natalie Bloom Lyons, M.S.

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 17, 2020
• Study Start: December 22, 2020
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-04

Locations

BE (2); US (11); NL (1); IT (1)