Pain, IntractableNCT06442410
Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
A study testing DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system and Conventional Medical Management (CMM) in people with Pain, Intractable and Pain, Chronic, run by MedtronicNeuro at 12 sites in 4 countries.
Trial summary
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Intractable, Pain, Chronic
- What is being tested?
- DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system and Conventional Medical Management (CMM)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 24 Jul 2020to 17 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Be a candidate for SCS system (trial and implant)
- Have been diagnosed with chronic, refractory axial low back pain with or without lower limb pain, with a neuropathic component as assessed by the investigator, 6 months refractory to conventional therapy and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
- Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
- Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
- Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent
- Be 18 years of age or older at the time of enrollment
- Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
- Be willing and able to comply with study-related requirements, procedures, and visits
Who cannot join
- Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
- Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
- Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and/or neurological disorders as determined by the Investigator
- Be concurrently participating in another clinical study
- Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
- Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
Show all 11Show fewer
- Has mechanical spine instability as determined by the Investigator
- Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
- Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
- Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
- Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Spain4 sites
Hospital Clínico Universitario de Santiago
A Coruña
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Hospital Universitario Virgen del Rocío
Seville
Hospital Clínico Universitario de Valencia
Valencia
Belgium3 sites
AZ Delta
Roeselare
AZ Nikolaas
Sint-Niklaas
GZA - Sint Augustinus Ziekenhuis
Wilrijk
Netherlands3 sites
Rijnstate - Locatie Elst
Elst
Maastricht University Medical Center
Maastricht
Diakonessenhuis Locatie Zeist
Zeist
Germany2 sites
Universitätsklinikum Düsseldorf
Düsseldorf
München Klinik Bogenhausen
München
About this study
Official title: Comparison of Differential Target Multiplexed Spinal Cord Stimulation (DTM™ SCS) Therapy Combined With CMM to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Surgery
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative treatment and are not candidates for lumbar spinal surgery.
- Conditions
- Pain, Intractable, Pain, Chronic
- Being tested
- DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system, Conventional Medical Management (CMM)
- Medical subject headings
- Pain, Intractable, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator systemDevice
Along with the appropriate Conventional Medical Management treatment made by the Investigator, the subject will be trialed and implanted with an Intellis™ neurostimulator system using DTM™ SCS programming parameters.
Conventional Medical Management (CMM)Other
The CMM treatment can be modified at any moment by the investigators based on their clinical evaluation and local standard of care. They may also consists of one or more of the following treatments: medications, combined physical and psychological management, physical therapy, back rehabilitation program, spinal manipulation and spinal mobilization, traction, acupuncture, cognitive behavioral therapy, biofeedback, nerve blocks, radio frequency ablation, epidural steroid injections, transcutaneous electrical nerve stimulation, intradiscal electrothermal therapy, nucleoplasty, also called plasma disc decompression (PDD) or similar
| Study group | Role | What they receive |
|---|---|---|
| Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM) | Experimental | Subjects will undergo a Trial Phase with DTM™ SCS programming. Stimulation will be delivered from an external neurostimulator. Those who have a "successful Trial Phase" will proceed to permanent implantation of the Intellis™ SCS system to evaluate DTM™ SCS therapy and will undergo up to 24 months of stimulation delivery.
Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the DTM™ SCS + CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the CMM group. If all SCS programming attempts fail, then DTM™ SCS therapy will be switched off and the subject will continue with their CMM treatment and will visit the clinic approximately a total of 18 months follow-up in the study (i.e. 6 months DTM™ SCS and 12 months CMM). Receives: Device: DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system; Other: Conventional Medical Management (CMM) |
| Control Group - Conventional Medical Management (CMM) alone | Active comparator | The choice of appropriate CMM will be made by the Investigator as determined to be the best standard of care for each individual subject i.e. optimized individual conventional therapy. These treatments would be generally consistent with the American College of Physicians and the American Pain Society Guidelines as published in the Annals of Internal Medicine and European/UK guidelines. Subjects in this group will also undergo up to 24 months of CMM.
Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the DTM™ SCS therapy group. Following their device activation, they will attend visits approximately a total of 18 months follow-up in the study (i.e. 6 months CMM and 12 months DTM™ SCS). Receives: Other: Conventional Medical Management (CMM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 6 months
Secondary outcomes (13)
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 1 month
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 3 months
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 9 months
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 12 months
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 18 months
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 24 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 1 month
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 3 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 6 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 9 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 12 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 18 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start24 Jul 2020
- Primary completion9 May 2022
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, IntractableStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: * DTM™ SCS programming approach with Conventional Medical Management (CMM) * CMM alone There is an optional two-way crossover to the other treatment group available for all subjects who remain in the study at the 6-months visit.
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGX Group
- Responsible party
- Sponsor
- Investigators
- Mirit Argov, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442410
- Sponsor's protocol ID
- MDT24011
- Other IDs
- ISRCTN10663814
- Status last verified
- Oct 2024
- First submitted
- 29 May 2024
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Differential Target Multiplexed Spinal Cord Stimulation (DTM™ SCS) Therapy Combined With CMM to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Surgery
- ClinicalTrials.gov ID
- NCT06442410
- Acronym / sponsor ID
- MDT24011
- Conditions
- Pain, Intractable, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Collaborators
- SGX Group
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative treatment and are not candidates for lumbar spinal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: * DTM™ SCS programming approach with Conventional Medical Management (CMM) * CMM alone There is an optional two-way crossover to the other treatment group available for all subjects who remain in the study at the 6-months visit.
| Arm | Type | Receives |
|---|---|---|
| Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM) | Experimental | Device: DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system, Other: Conventional Medical Management (CMM)Subjects will undergo a Trial Phase with DTM™ SCS programming. Stimulation will be delivered from an external neurostimulator. Those who have a "successful Trial Phase" will proceed to permanent implantation of the Intellis™ SCS system to evaluate DTM™ SCS therapy and will undergo up to 24 months of stimulation delivery. Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the DTM™ SCS + CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the CMM group. If all SCS programming attempts fail, then DTM™ SCS therapy will be switched off and the subject will continue with their CMM treatment and will visit the clinic approximately a total of 18 months follow-up in the study (i.e. 6 months DTM™ SCS and 12 months CMM). |
| Control Group - Conventional Medical Management (CMM) alone | Active comparator | Other: Conventional Medical Management (CMM)The choice of appropriate CMM will be made by the Investigator as determined to be the best standard of care for each individual subject i.e. optimized individual conventional therapy. These treatments would be generally consistent with the American College of Physicians and the American Pain Society Guidelines as published in the Annals of Internal Medicine and European/UK guidelines. Subjects in this group will also undergo up to 24 months of CMM. Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the DTM™ SCS therapy group. Following their device activation, they will attend visits approximately a total of 18 months follow-up in the study (i.e. 6 months CMM and 12 months DTM™ SCS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be a candidate for SCS system (trial and implant)
- Have been diagnosed with chronic, refractory axial low back pain with or without lower limb pain, with a neuropathic component as assessed by the investigator, 6 months refractory to conventional therapy and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
- Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
- Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
- Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent
Key exclusion criteria (11 listed)
- Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
- Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
- Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and/or neurological disorders as determined by the Investigator
- Be concurrently participating in another clinical study
- Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
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 |
|---|---|---|
| DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator systemAlong with the appropriate Conventional Medical Management treatment made by the Investigator, the subject will be trialed and implanted with an Intellis™ neurostimulator system using DTM™ SCS programming parameters. | Device | Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM) |
| Conventional Medical Management (CMM)The CMM treatment can be modified at any moment by the investigators based on their clinical evaluation and local standard of care. They may also consists of one or more of the following treatments: medications, combined physical and psychological management, physical therapy, back rehabilitation program, spinal manipulation and spinal mobilization, traction, acupuncture, cognitive behavioral therapy, biofeedback, nerve blocks, radio frequency ablation, epidural steroid injections, transcutaneous electrical nerve stimulation, intradiscal electrothermal therapy, nucleoplasty, also called plasma disc decompression (PDD) or similar | Other | Control Group - Conventional Medical Management (CMM) alone, Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM) |
Primary outcome
Percentage of Individual Responders
Time frame: 6 months
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
13 secondary outcomes
Percentage of Individual Responders
Time frame: 1 month
Percentage of Individual Responders
Time frame: 3 months
Percentage of Individual Responders
Time frame: 9 months
Percentage of Individual Responders
Time frame: 12 months
Percentage of Individual Responders
Time frame: 18 months
Percentage of Individual Responders
Time frame: 24 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Time frame: 1 month
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Time frame: 3 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Time frame: 6 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Time frame: 9 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Time frame: 12 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Time frame: 18 months
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ISRCTN Registry postingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mirit Argov study director
Medtronic
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system and Conventional Medical Management (CMM) in people with Pain, Intractable and Pain, Chronic, run by MedtronicNeuro at 12 sites in 4 countries.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Belgium, Netherlands, 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?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Individual Responders (time frame: 6 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 7 Nov 2024.