Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs

Chronic Pain Clinical Trial

— Prodigy-I  

Official title:

A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143791
• Other study ID #: NM-13-038-ID-SC
• Status: Completed
• Phase: N/A
• First received: May 19, 2014
• Last updated: November 10, 2016
• Start date: June 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: St. Jude Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain

• Patient is considered by the investigator as a candidate for implantation of a SCS system

• Patient is = 18 years of age

• Patient must be willing and able to comply with study requirements

• Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form

Exclusion Criteria:

• Patient is immune-compromised

• Patient has history of cancer requiring active treatment in the last 6 months

• Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months

• Patients with a SCS system or implantable infusion pump implanted previously

• Patient has a life expectancy of less than one year

• Patient is pregnant or is planning to become pregnant during the duration of the investigation

• Patient is unable to comply with the follow up schedule

• Patient needing legally authorized representative

• Patient unable to read and write

• Patient is currently participating in another clinical investigation with an active treatment arm

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Failed Back Surgery Syndrome

Intervention

Procedure:
• Burst stimulation

Device:
• Prodigy system

Locations

Country	Name	City	State
Australia	Metro Spinal Clinic	Caulfield
Australia	Frankston Pain Management	Frankston
Australia	Epworth Hospital	Richmond
Belgium	St Augustinus Ziekenhuis	Wilrijk	Antwerp
Germany	University Hospital	Duesseldorf
Germany	Hospital Gera	Gera
Germany	Medizinische Einrichtungen der Universität zu Köln	Köln
Germany	Universitätsklinik für Stereataktische Neurochirurgie	Magdeburg
Germany	Universitatsklinikum Tubingen	Tubingen
Ireland	St Vincents University Hospital	Dublin
Italy	Azienda Ospedaliera Monaldi	Napoli
Italy	Az. Ospedaliero-Universitaria Pisana - Stabilimento Santa Chiara	Pisa
Italy	Az. Osp.S.Giovanni Addolorata	Roma
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	St Antonius Ziekenhuis	Nieuwegein
Netherlands	Stichting Alysis Zorggroep	Velp
Spain	Hospital Virgen de Rocio	Sevilla
Sweden	University Hospital	Uppsala
United Kingdom	Seacroft Hospital	Leeds
United Kingdom	St Bartolomew's	London
United Kingdom	James Cook University Hospital	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Medical

Countries where clinical trial is conducted

Australia,  Belgium,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the percentage of pain relief at the 3-month visit compared to baseline visit, as measured by the Visual Analog Scale (VAS).		3 months	No
Secondary	Rate of serious adverse events (SAEs) and/or procedure/device-related adverse events ((S)ADEs)		from enrollment to 12 months follow up	Yes