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Trial record 2 of 29 for:    axium

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

This study has been terminated.
(Sponsor withdrawn due to low inclusion rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02349659
First Posted: January 29, 2015
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frederique Mol, Maxima Medical Center
  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
Intervention Model: Crossover Assignment
Masking: None (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 Frederique Mol, Maxima Medical Center:

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 ]

Enrollment: 18
Study Start Date: December 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: July 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349659


Locations
Netherlands
Máxima Medisch Centrum
Eindhoven, Netherlands
Sponsors and Collaborators
Maxima Medical Center
  More Information

Responsible Party: Frederique Mol, drs., Maxima Medical Center
ClinicalTrials.gov Identifier: NCT02349659     History of Changes
Other Study ID Numbers: 24-SMI-2014
First Submitted: January 9, 2015
First Posted: January 29, 2015
Last Update Posted: February 1, 2017
Last Verified: January 2017