Post Surgical Groin PainBRAVONCT02346656
a BavaRiAn eValuatiOn of Dorsal Root Ganglion (DRG) Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin
An observational study of Post Surgical Groin Pain, run by Abbott Medical Devices at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Surgical Groin Pain
- What is being tested?
- Implantation with the commercially available Axium neurostimulator
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post Surgical Groin Pain Patients
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Post Surgical Groin Pain
- Being tested
- Implantation with the commercially available Axium neurostimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation with the commercially available Axium neurostimulatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Treated subjects | All subjects recruited and treated with the Axium neurostimulator Receives: Device: Implantation with the commercially available Axium neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief - Assessed by Change in Pain Intensity Assessed using a Visual Analogue Scale (VAS) from Pre-Treatment Baseline
Measured: Post treatment at; 1 week and 1, 3, 6 and12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Inadequate Enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Surgical Groin PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346656
- Sponsor's protocol ID
- 15-SMI-2013
- Acronym
- BRAVO
- Status last verified
- Feb 2019
- First submitted
- 9 Jan 2015
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAVO: a BavaRiAn eValuatiOn of DRG Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin
- ClinicalTrials.gov ID
- NCT02346656
- Acronym / sponsor ID
- BRAVO / 15-SMI-2013
- Conditions
- Post Surgical Groin Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate Enrolment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated subjects | – | Device: Implantation with the commercially available Axium neurostimulatorAll subjects recruited and treated with the Axium neurostimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post Surgical Groin Pain Patients
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation with the commercially available Axium neurostimulator | Device | Treated subjects |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Inadequate Enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Surgical Groin Pain, run by Abbott Medical Devices at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate Enrolment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.