Post Surgical Groin PainGASPANCT02337699
Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain
An observational study of Post Surgical Groin Pain, run by Abbott Medical Devices at 1 site in Netherlands.
Trial summary
25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Read more about this study
- Who is it for?
- Ages 18 to 18 years, men only
- Conditions the study is for
- Post Surgical Groin Pain
- What is being tested?
- Implantation with the commercially available Axium neurostimulator and QST Testing
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2015to 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 to 18 years
- Men only
- No healthy volunteers
- Adult
Study population: Chronic Post Surgical Groin Pain Patients
Who may be able to join
- Male
- Age between >18 and <65 years
- Unilateral post surgical groin pain for >6 months
- Pain localized to the region defined by the anterior superior iliac spine (ASIS), the pubic tubercle, and the groin-gluteal-greater trochanter triangles (3G) point,
- Pain has no surgical indication
- Subjects meet the criteria for SCS implantation as set out in the Dutch Neuromodulation Society Guideline
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- Pain characterized by neuropathy and/or allodynia
- Average daily baseline pain intensity baseline VAS greater than or equal to 50 mm on a 100mm VAS scale
- Patient willing and able to give informed consent and to participate in observational study
Who cannot join
- Inability to speak/read Dutch
- Bilateral and/or recurrent hernia.
- Radiofrequency or injection therapy at or close to a target DRG in the 90 days prior to enrolment
- Current illicit drug use and/or alcohol dependence
- Active infection, or conditions or indwelling devices that pose an increased risk of infection
- Active implantable device including implantable cardiac defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
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- Participation in another clinical study during the study period.
- Any other disorder, condition, or circumstance that, in the opinion of the principal investigator, represents a risk to successful completion of all study activities.
- Additional Criteria for nested feasibility study
- Additional Inclusion Criteria
- Participation in the observational study
- Sign off for sub-study on patient informed consent
- Additional Exclusion Criteria
- 1. For sub-study participation only: pain conditions [aside from the post surgical groin pain to be treated], extensive scar tissue, skin conditions, or sensorimotor abnormalities in the areas for QST assessments: the painful groin, the contralateral groin, the ipsilateral arm, and the contralateral hand
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DORSAL ROOT GANGLION STIMULATION AS TREATMENT FOR POSTSURGICAL GROIN PAIN (GASPA Study)
25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.
- Conditions
- Post Surgical Groin Pain
- Being tested
- Implantation with the commercially available Axium neurostimulator, QST Testing
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
QST TestingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Treated Subjects | All subjects recruited into the main study treated with the Axium neurostimulator Receives: Device: Implantation with the commercially available Axium neurostimulator | |
| QST Group | A sub-set of the main study group who also consent to take part in the Quantitative Sensory Testing based feasibility study Receives: Device: Implantation with the commercially available Axium neurostimulator; Procedure: QST Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline
Measured: Post implantation at; 1, 3 and 6 months
Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale
Measured: Baseline then Post implantation at; 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: The Principal investigator retired without replacement. Only one patient was enrolled and completed the entire study without adverse events.
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
- 1 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
- NCT02337699
- Sponsor's protocol ID
- 25-SMI-2014
- Acronym
- GASPA
- Status last verified
- Jan 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
- DORSAL ROOT GANGLION STIMULATION AS TREATMENT FOR POSTSURGICAL GROIN PAIN (GASPA Study)
- ClinicalTrials.gov ID
- NCT02337699
- Acronym / sponsor ID
- GASPA / 25-SMI-2014
- Conditions
- Post Surgical Groin Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Principal investigator retired without replacement. Only one patient was enrolled and completed the entire study without adverse events.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 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.
25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated Subjects | – | Device: Implantation with the commercially available Axium neurostimulatorAll subjects recruited into the main study treated with the Axium neurostimulator |
| QST Group | – | Device: Implantation with the commercially available Axium neurostimulator, Procedure: QST TestingA sub-set of the main study group who also consent to take part in the Quantitative Sensory Testing based feasibility study |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Chronic Post Surgical Groin Pain Patients
Key inclusion criteria (9 listed)
- Male
- Age between >18 and <65 years
- Unilateral post surgical groin pain for >6 months
- Pain localized to the region defined by the anterior superior iliac spine (ASIS), the pubic tubercle, and the groin-gluteal-greater trochanter triangles (3G) point,
- Pain has no surgical indication
Key exclusion criteria (14 listed)
- Inability to speak/read Dutch
- Bilateral and/or recurrent hernia.
- Radiofrequency or injection therapy at or close to a target DRG in the 90 days prior to enrolment
- Current illicit drug use and/or alcohol dependence
- Active infection, or conditions or indwelling devices that pose an increased risk of infection
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 | QST Group, Treated Subjects |
| QST Testing | Procedure or surgery | QST Group |
Primary outcome
Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline
Time frame: Post implantation at; 1, 3 and 6 months
Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale
Time frame: Baseline then Post implantation at; 1, 3 and 6 months
Results and safety
The study was stopped early (reason given: The Principal investigator retired without replacement. Only one patient was enrolled and completed the entire study without adverse events.). 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 Netherlands.
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 9 inclusion and 14 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 Netherlands. 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: The Principal investigator retired without replacement. Only one patient was enrolled and completed the entire study without adverse events.). 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?
Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline (time frame: Post implantation at; 1, 3 and 6 months). The study lists 2 primary outcomes in all. 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.