Trial record 2 of 25 for:    axium

A Multi-Centre RCT of the Axium® Neurostimulator for the Treatment of Chronic Inguinal Pain Following Surgery (SMASHING)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT02349659
First received: January 9, 2015
Last updated: December 15, 2015
Last verified: December 2015
  Purpose
24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM. Subject population is chronic inguinal pain refractory to previous surgical intervention (neurectomy).

Condition Intervention
Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)
Device: Implantation with the commercially available Axium neurostimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Evaluate the Efficacy of the Spinal Modulation Axium® NeuroStimulator THerapy as a Treatment for Persistent INGuinal Pain Following Surgical Intervention: SMASHING

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Percentage of subjects experiencing ≥50% reduction in average daily pain intensity in the Axium Group as compared to the CMM only group using an eleven point (0-10) numerical pain rating scale (NPRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: December 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conservative Medical Management
Continued medical management restricted to exclude interventional pain treatments
Active Comparator: Axium Group
As the CMM group but also treated with Dorsal Root Ganglion stimulation using the Axium neurostimulator
Device: Implantation with the commercially available Axium neurostimulator

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years old
  2. Subject is able and willing to comply with the follow-up schedule and protocol
  3. Chronic inguinal pain following Pfannenstiel Incision or Open Inguinal Hernia Repair for at least 6 months
  4. Previously undergone neurectomy procedure as a treatment for chronic inguinal pain
  5. Minimum daily average baseline pain rating of 5 out of 10 in the inguinal area on an 11-point NPRS
  6. Subject is able to provide written informed consent
  7. Meets of the inclusion criteria for the implantation of a neurostimulation system as set out by the Dutch Neuromodulation Society
  8. Subject has been screened by a multi-disciplinary panel including the designated psychologist of the Máxima Medical Center and deemed suitable for implantation

Exclusion Criteria:

  1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the Trial
  2. Escalating or changing pain condition within the past month as evidenced by investigator examination
  3. Subject has had injection therapy or radiofrequency treatment of a target neural structure within the past 3 months
  4. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
  5. Subject is unable to operate the device
  6. Subjects currently has an active infection
  7. Subject has participated in another clinical investigation within 30 days
  8. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
  9. Subject has a current or on going condition, which will probably require MRI investigation sometime in the following 2 years
  10. Subject has had a spinal surgical procedure at or between vertebral levels T10-L2
  11. Subject has been diagnosed with cancer in the past 2 years, except for skin malignancies.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02349659

Contacts
Contact: Roni Diaz 0019723098601 rdiaz@sjm.com
Contact: Hernan Castro 0031646805720 hcastro04@sjm.com

Locations
Netherlands
Máxima Medisch Centrum Recruiting
Eindhoven, Netherlands
Contact: F Mol, Dr (Med)    0031408888000      
Sub-Investigator: R Roumen, Dr (Med)         
Sub-Investigator: M Scheltinga, Dr (Med)         
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02349659     History of Changes
Other Study ID Numbers: 24-SMI-2014 
Study First Received: January 9, 2015
Last Updated: December 15, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

ClinicalTrials.gov processed this record on August 24, 2016