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

Post Surgical Groin Pain Clinical Trial

— BRAVO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02346656
• Other study ID #: 15-SMI-2013
• Status: Terminated
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Surgical Groin Pain

Intervention

Device:
• Implantation with the commercially available Axium neurostimulator

Locations

Country	Name	City	State
Germany	Algesiologikum Zentrum für Schmerzmedizin	München

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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