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

February 1, 2019 updated by: Abbott Medical Devices

BRAVO: a BavaRiAn eValuatiOn of DRG Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany
        • Algesiologikum Zentrum für Schmerzmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Post Surgical Groin Pain Patients

Description

Inclusion Criteria:

  1. The patient is at least 18 years old
  2. The patient is willing and able to comply with the examination schedule and the trial schedule.
  3. The patient has suffered from chronic post-surgical neuropathic groin pain for at least 6 months
  4. Conservative treatments of the chronic pain including medication, physiotherapy and interventions have been exhausted
  5. 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)
  6. The patient is able to give consent in writing

Exclusion Criteria:

  1. Pregnant or breastfeeding patients or those who plan to become pregnant during the study
  2. 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.
  3. In the last 30 days, the patient has been treated with corticosteroids on an area scheduled for the stimulation.
  4. In the last 3 months, the patient has been treated with radio frequency therapy on an area scheduled for the stimulation.
  5. 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.
  6. The patient is not able to operate the stimulation device
  7. The patient is currently suffering from an infection
  8. The patient has participated in another clinical study in the last 30 days
  9. The patient has a coagulation disorder or is taking anti-coagulants, which would make participation impossible, as per the study doctor
  10. The patient has been diagnosed with a malignancy in the past 2 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treated subjects
All subjects recruited and treated with the Axium neurostimulator
Device: Implantation with the commercially available Axium neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Relief - Assessed by Change in Pain Intensity Assessed using a Visual Analogue Scale (VAS) from Pre-Treatment Baseline
Time Frame: Post treatment at; 1 week and 1, 3, 6 and12 months
Post treatment at; 1 week and 1, 3, 6 and12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-SMI-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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