Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 21 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 January 2015 by Spinal Modulation, Inc.
Sponsor:
Information provided by (Responsible Party):
Spinal Modulation, Inc.
ClinicalTrials.gov Identifier:
NCT02349659
First received: January 9, 2015
Last updated: January 23, 2015
Last verified: January 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 Spinal Modulation, Inc.:

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: August 2017
Estimated Primary Completion Date: December 2016 (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 DRG stimulation using the Axium neurostimulator
Device: Implantation with the commercially available Axium neurostimulator

  Eligibility

Ages Eligible for Study:   18 Years and older
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 ICD, 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: Dave Mugan 00447557370074 dmugan@spinalmodulation.com
Contact: Carin Wensing 0031611868068 carin@spinalmodulation.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
Spinal Modulation, Inc.
  More Information

No publications provided

Responsible Party: Spinal Modulation, Inc.
ClinicalTrials.gov Identifier: NCT02349659     History of Changes
Other Study ID Numbers: 24-SMI-2014
Study First Received: January 9, 2015
Last Updated: January 23, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

ClinicalTrials.gov processed this record on February 27, 2015