a BavaRiAn eValuatiOn of Dorsal Root Ganglion (DRG) Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin

NCT02346656 | Terminated

• 1 other identifier: 15-SMI-2013
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

15-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical groin pain

Conditions

Post Surgical Groin Pain

Outcome Measures

Primary Outcomes (1)

• Pain Relief - Assessed by Change in Pain Intensity Assessed using a Visual Analogue Scale (VAS) from Pre-Treatment Baseline

  Post treatment at; 1 week and 1, 3, 6 and12 months

Study Arms (1)

Treated subjects

All subjects recruited and treated with the Axium neurostimulator

Device: Implantation with the commercially available Axium neurostimulator

Interventions

Implantation with the commercially available Axium neurostimulator DEVICE

Treated subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post Surgical Groin Pain Patients

You may qualify if:

• The patient is at least 18 years old
• The patient is willing and able to comply with the examination schedule and the trial schedule.
• The patient has suffered from chronic post-surgical neuropathic groin pain for at least 6 months
• Conservative treatments of the chronic pain including medication, physiotherapy and interventions have been exhausted
• The pain level at the time of the baseline examination is at least 60mm on the visual analogue scale (VAS) in the primary pain area (groin pain)
• The patient is able to give consent in writing

You may not qualify if:

• Pregnant or breastfeeding patients or those who plan to become pregnant during the study
• It has been established in an examination by the tester that the pain has significantly worsened or changed its characteristics in the course of the previous month.
• In the last 30 days, the patient has been treated with corticosteroids on an area scheduled for the stimulation.
• In the last 3 months, the patient has been treated with radio frequency therapy on an area scheduled for the stimulation.
• The patient has already been treated with an active implantable device, including an implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or an intrathecal medication pump.
• The patient is not able to operate the stimulation device
• The patient is currently suffering from an infection
• The patient has participated in another clinical study in the last 30 days
• The patient has a coagulation disorder or is taking anti-coagulants, which would make participation impossible, as per the study doctor
• The patient has been diagnosed with a malignancy in the past 2 years

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Algesiologikum Zentrum für Schmerzmedizin

München, Germany

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 27, 2015
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

DE (1)