AzTrials
AzTrials

Chronic PainPRONCT01550575

Patient Retrospective Outcomes (PRO)

An observational study of Chronic Pain, run by Boston Scientific Corporation at 145 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Non Boston Scientific Systems and Boston Scientific Systems
Type of treatment
Medical device
How many people
15,000 participants
Where
145 sitesin 14 countries
Study dates
3 Apr 2012to Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects who have previously been implanted with, or who are candidates for implantation with a spinal cord stimulation system or other various treatment approaches, such as radio frequency ablation or indirect decompression system (IDS).

Who may be able to join

  • Previously treated with or eligible for use with Boston Scientific Systems
  • 18 years of age or older at the start of Baseline

Who cannot join

None listed.

Trial locations and contacts

145 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

145 sites in 14 countries

United States87 sites, 29 recruiting
  • Vidant Roanoke - Chowan Hospital Pain Center

    Ahoskie, North Carolina, 27910

    Completed
  • Albany Medical Center

    Albany, New York, 12208

    Completed
  • Pain Center Physicians

    Austin, Texas, 78704

    Completed
  • Balcones Pain Consultants

    Austin, Texas, 78750

    Completed
  • Jeffrey M. Epstein, M.D. PC

    Babylon, New York, 11702

    Completed
  • Kern Neuroscience Institute

    Bakersfield, California, 93306

    Completed
  • Saint Louis Pain Consultants

    Chesterfield, Missouri, 63017

    Completed
  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Completed
  • Pain Consultants of San Diego

    Chula Vista, California, 91914

    Completed
  • Interventional Pain and Spine

    Cincinnati, Ohio, 45202

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Orlando Health Neuroscience Institute

    Clermont, Florida, 34711

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Completed
  • Barolat Neuroscience

    Denver, Colorado, 80218

    Completed
  • Orthopaedic and Spine Center

    Dublin, Ohio, 43016

    Withdrawn
  • Twin Cities Pain Clinic & Surgery Center

    Edina, Minnesota, 55439

    Completed
  • Pacific Sports and Spine, LLC

    Eugene, Oregon, 97401

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • Cincinnati Comprehensive Pain Center

    Fairfield, Ohio, 45014

    Completed
  • Florence Neurosurgery and Spine

    Florence, South Carolina, 29506

    Completed
  • Florida Spine Specialists

    Fort Lauderdale, Florida, 33308

    Completed
  • Summit Research Institute

    Fort Wayne, Indiana, 46825

    Completed
  • Pain Medicine Associates, Inc.

    Fountain Valley, California, 92708

    Withdrawn
  • PCPMG Clinical Research Unit, LLC

    Greenville, South Carolina, 29601

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • NeuroSpecs-Gulfport Performance Spine

    Gulfport, Mississippi, 39503

    Completed
  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

    Completed
  • KSF Orthopaedics

    Houston, Texas, 77090

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Carolinas Research Institute, PLLC

    Huntersville, North Carolina, 28078

    Completed
  • Pain and Spine Specialists of Idaho

    Idaho Falls, Idaho, 83404

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • Louis J. Raso, MD, PA

    Jupiter, Florida, 33477

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • Western Reserve Spine and Pain Institute

    Kent, Ohio, 44240

    Completed
  • Central Texas Pain Institute

    Kileen, Texas, 76542

    Completed
  • EvergreenHealth Pain Care

    Kirkland, Washington, 98034

    Completed
  • UCSD Medical Center - Jacobs Medical Center

    La Jolla, California, 92037

    Completed
  • Lakeside Spine & Pain

    Lake Havasu City, Arizona, 86403

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Michigan Orthopedic Center

    Lansing, Michigan, 48910

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Advanced Spine Pain Solutions

    Laredo, Texas, 78041

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • California Orthopedics & Spine

    Larkspur, California, 94939

    Completed
  • MarinHealth Spine Institute

    Larkspur, California, 94939

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Loma Linda University Medical Center

    Loma Linda, California, 92354

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Interventional Spine and Pain Center

    Manchester, Tennessee, 37355

    Completed
  • Pain Specialists of Southern Oregon

    Medford, Oregon, 97504

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Quave Clinic

    Medford, Oregon, 97504

    Completed
  • Southern Oregon Orthopedics

    Medford, Oregon, 97504

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Florida Pain Institute

    Merritt Island, Florida, 32953

    Completed
  • Advanced Interventional Pain Management and Research Clinic, Inc.

    Miami Gardens, Florida, 33169

    Completed
  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506

    Completed
  • Pain and Spine Specialist of Maryland

    Mount Airy, Maryland, 21771

    Completed
  • Comprehensive Pain and Spine Specialists

    Muncie, Indiana, 47304

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Comprehensive Pain & Neurology Center

    Murfreesboro, Tennessee, 37128

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Crystal Coast Pain Management

    New Bern, North Carolina, 28560

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • Henry Community Health

    New Castle, Indiana, 47362

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Advanced Diagnostic Pain Treatment Centers

    New Haven, Connecticut, 06511

    Completed
  • Newport Beach Headache and Pain

    Newport Beach, California, 92660

    Completed
  • Florida Pain Clinic

    Ocala, Florida, 34471

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • Multidisciplinary Pain Management Services

    Okemos, Michigan, 48864

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • Precision Spine Care

    Overland Park, Kansas, 66211

    Completed
  • Comprehensive Pain & Rehabilitation

    Pascagoula, Mississippi, 39581

    Completed
  • Orthomicrospine

    Pensacola, Florida, 32503

    Completed
  • HCA Florida West Orthopedic Specialists

    Pensacola, Florida, 32514

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • West Florida Orthopedics and Spine Surgery

    Pensacola, Florida, 32514

    Completed
  • Hope Research Institute

    Phoenix, Arizona, 85018

    Completed
  • Summit Spine

    Portland, Oregon, 97225

    Completed
  • North Idaho Day Surgery

    Post Falls, Idaho, 83854

    Completed
  • Vitamed Research

    Rancho Mirage, California, 92270

    Completed
  • Interventional Pain Specialists of Wisconsin

    Rice Lake, Wisconsin, 54868

    Completed
  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

    Completed
  • Piedmont Interventional Pain Care

    Salisbury, North Carolina, 28147

    Completed
  • University of Utah Orthopaedic Center

    Salt Lake City, Utah, 84108

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Orthopedic Research Foundation

    Savannah, Georgia, 31405

    Withdrawn
  • Mind Your Body Institute

    Seattle, Washington, 98115

    Completed
  • Willis-Knighton River Cities Clinical Research Center

    Shreveport, Louisiana, 71105

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • Spine Team Texas

    Southlake, Texas, 76092

    Completed
  • Northwest Pain Care

    Spokane, Washington, 99201

    Completed
  • Mercy Medical Research Institute

    Springfield, Missouri, 65804

    Completed
  • Montefiore Medical Center

    The Bronx, New York, 10461

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Interventional Pain Consultants

    Toledo, Ohio, 43623

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Toledo Clinic

    Toledo, Ohio, 43623

    Completed
  • University of Toledo Medical Center

    Toledo, Ohio, 43623

    Completed
  • Spine and Skeletal Pain Medicine

    Utica, New York, 13502

    Completed
  • Pacific Pain Management, Inc.

    Ventura, California, 93003

    Completed
  • Interventional Spine and Pain Institute

    Vero Beach, Florida, 32960

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • IPM Medical Group Inc.

    Walnut Creek, California, 94598

    Completed
  • Centurion Spine and Pain

    Waycross, Georgia, 31522

    Completed
  • Space City Pain Specialists

    Webster, Texas, 77598

    Completed
  • Integrative Pain and Wellness Associates

    Williamsville, New York, 14221

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • The Center for Clinical Research, LLC

    Winston-Salem, North Carolina, 27103

    Boston Scientific Clinical Research Manager, 8552139890, BSNClinicalTrials@bsci.com

    Recruiting
  • Forest Health Medical Center

    Ypsilanti, Michigan, 48198

    Completed

Other trials in United States

Spain15 sites, 13 recruiting
  • Hospital De Bellvitge

    Barcelona

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • H. Puerta Del Mar

    Cadiz

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Complejo Hospitalario Universitario de Cartagena

    Cartagena

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital Universitario Doctor Jose Molina Orosa

    Las Palmas

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital San Pedro

    Logroño

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Fundacion Jimenez Diaz

    Madrid

    Completed
  • Hospital Clinico San Carlos

    Madrid

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital La Paz

    Madrid

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital Universitario Quiron Madrid

    Madrid

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital Puerta de Hierro

    Majadahonda

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Complexo Hospitalario Universitario de Ourense (CHUO)

    Ourense

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital Virgen Del Rocio

    Seville

    Completed
  • H. Clinico Universitario

    Valencia

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital de la Ribera

    Valencia

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital Universitario La Fe

    Valencia

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Spain

Australia8 sites
  • Berwick Pain Management

    Berwick

    Completed
  • Hunter Pain Clinic

    Broadmeadow

    Completed
  • Monash Clinical Research

    Caulfield South

    Completed
  • Green Lizard Science

    Claremont

    Completed
  • Sydney Spine and Pain Pty Ltd

    Hurstville

    Completed
  • Sunshine Coast Clinical Research

    Noosa

    Completed
  • Womens Health and Research Institute of Australia

    Sydney

    Completed
  • Pain Medicine of South Australia

    Wayville

    Completed

Other trials in Australia

France8 sites, 6 recruiting
  • Polyclinique du Parc

    Caen

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • CHU Henri Mondor

    Créteil

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Clinique de la Sauvegarde

    Lyon

    Completed
  • Hopital Prive du Confluent SAS

    Nantes

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • CHU La Miletrie

    Poitiers

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • CHU de Nantes-Hopital Laennec

    Saint-Herblain

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hopital Foch

    Suresnes

    Completed

Other trials in France

Italy7 sites, 7 recruiting
  • Pres. Osp. Civile Santi Antonio e Biagio

    Alessandria

    Boston Scientific Clinical Reseacrh, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Az. Osp. Monaldi

    Naples

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • AUSL della Romagna

    Ravenna

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Ospedale San Giuliano

    Rionero in Vulture

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Ospedale S. Giovanni Addolorata

    Rome, 30326

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Policlinico Universitario Agostino Gemelli

    Rome

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Italy

United Kingdom6 sites, 6 recruiting
  • Basildon and Thurrock University Hospitals NHS

    Basildon

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Southmead Hospital Bristol

    Bristol

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Royal Devon & Exeter Hospital

    Exeter

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • The General Infirmary

    Leeds

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • St. Bartholomews Hospital

    London

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • James Cook University Hospital

    Middlesbrough

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in United Kingdom

Germany5 sites, 5 recruiting
  • Inter Neuro

    Berlin

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Uniklinik Köln

    Cologne

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Universitaetsklinikum Dusseldorf

    Düsseldorf

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • St. Marien-Hospital Hamm

    Hamm

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • University Berlin, Charite Virchow Standort, Wedding

    Wedding

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Germany

Netherlands2 sites, 1 recruiting
  • Alrijne Ziekenhuis Leiderdorp

    Leiderdorp

    Completed
  • Ziekenhuis Rijnstate

    Velp

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Netherlands

Switzerland2 sites, 1 recruiting
  • La Tour Hospital

    Meyrin

    Completed
  • Ospedale Regionale di Lugano

    Viganello

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Switzerland

Belgium1 site, 1 recruiting
  • Clinique Saint-Pierre Ottignies

    Ottignies

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Belgium

Portugal1 site, 1 recruiting
  • CHU Sao Joao

    Porto

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Portugal

Puerto Rico1 site
  • Ponce Interventional Pain Center

    Ponce, 716

    Completed

Other trials in Puerto Rico

Sweden1 site
  • Sahlgrenska University Hospital

    Gothenburg

    Completed

Other trials in Sweden

Turkey (Türkiye)1 site, 1 recruiting
  • Izmir Bakircay Üniversitesi

    Izmir

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

Read the detailed description

This study is a retrospective, multi-center, de-identified patient data review.

The study will include multiple independent cohorts to evaluate clinical outcomes in different subgroups.

Conditions
Chronic Pain
Being tested
Non Boston Scientific Systems, Boston Scientific Systems
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non Boston Scientific SystemsDevice

    Spinal cord stimulation, RF, IDS etc.

  • Boston Scientific SystemsDevice

    Spinal cord stimulation, RF, IDS etc

Study groups in NCT01550575
Study groupRoleWhat they receive
Patients eligible for SCS, RF or other treatment approachesPatients who have previously been implanted with, or are eligible for implantation with a spinal cord stimulation system or various other treatment approaches such as RF, IDS, etc.
Receives: Device: Non Boston Scientific Systems; Device: Boston Scientific Systems
Patients Eligible for treatment options with prior treatmentPatients who have previously been implanted with a spinal cord stimulation system or other various treatments, and have thereafter received a different form of chronic pain treatment such as a different SCS system, RF, IDS etc.
Receives: Device: Non Boston Scientific Systems; Device: Boston Scientific Systems

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Responder rate

    Responder rate for pain relief through study completion.

    Measured: Through study completion, approximately two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2012 (estimated)
  2. Study start3 Apr 2012
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
Retrospective
Enrolment
15,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01550575
Sponsor's protocol ID
A7005
Acronym
PRO
Status last verified
Oct 2026
First submitted
5 Mar 2012
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No

Publications

  • Ferro R, North J, Kranenburg A, Pyles S, Dorenkamp C, Poston J, Schneider J, Auten K, Goldberg E. Automated Neural Dosing for Fast-Acting Subperception Therapy: Sustained Spinal Cord Stimulation Outcomes from a Multicenter Study. Pain Ther. 2025 Aug;14(4):1417-1429. doi: 10.1007/s40122-025-00758-y. Epub 2025 Jul 3.

    PubMed 40603812
  • Metzger C, Hammond B, Ferro R, North J, Pyles S, Kranenburg A, Washabaugh E, Goldberg E. Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States. Expert Rev Med Devices. 2025 Jan-Feb;22(2):155-164. doi: 10.1080/17434440.2025.2453554. Epub 2025 Jan 16.

    PubMed 39819320

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain, run by Boston Scientific Corporation at 145 sites in 14 countries.

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 2 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Spain, Australia, France, Italy and 9 more countries. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alison Lewis (855-213-9890, BSNClinicalTrials@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rate (time frame: Through study completion, approximately two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01550575, which also lists 2 linked publications.

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 9 Oct 2026.

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