Severe SpasticityNCT00773019
SynchroMed II Post-Approval Study
An observational study of Severe Spasticity and Chronic Pain, run by MedtronicNeuro.
Trial summary
This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers. Subjects are selected from those evaluated and planning to receive a SynchroMed II drug infusion system for treatment of severe spasticity or chronic pain. Subjects must return for refill visits at 1, 6, and 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Spasticity, Chronic Pain
- What is being tested?
- Refills (SynchroMed® II Programmable Drug Infusion Pump)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Nov 2008
- 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: Subjects planning to receive a new or replacement drug pump.
Who may be able to join
- Have chronic intractable severe spasticity or chronic pain requiring intrathecal delivery of medication
- Have undergone a pre-implant assessment and determined to be an appropriate candidate for implantation of an infusion system
- Be geographically stable and willing to return to the study center for follow-up visits
- Subject, or subject's legal representative, has signed informed consent form prior to any study-related procedures
- Age is at least 18 years of age at time of enrollment
Who cannot join
- Have a condition in which the pump cannot be implanted 2.5 cm or less from the surface of the skin
- Have an ongoing infection prior to implant
- Have insufficient body mass to accept the pump bulk and weight
- Are unable or unwilling to adhere to the study protocol
- Have an estimated life expectancy of less than twelve months
About this study
Official title: SynchroMed II Programmable Drug Infusion System Post-Approval Study
This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers. Subjects are selected from those evaluated and planning to receive a SynchroMed II drug infusion system for treatment of severe spasticity or chronic pain. Subjects must return for refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically necessary refills. Information is collected on all refills and adverse events.
- Conditions
- Severe Spasticity, Chronic Pain
- Being tested
- Refills (SynchroMed® II Programmable Drug Infusion Pump)
- Keywords
- infusion pump, implantable, performance
- Medical subject headings
- Muscle Spasticity, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refills (SynchroMed® II Programmable Drug Infusion Pump)Device
Refill information at 1, 6, and 12 months post-implant, as well as any additional refills required from implant through end of study. Amount removed from the pump (taken from syringe), Amount placed in the pump (from syringe),Pump predicted amount remaining in the pump.
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed
Measured: six months
Secondary outcomes (1)
Characterize adverse events experienced with the drug infusion system
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startNov 2004
- Primary completionJun 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SpasticityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773019
- Sponsor's protocol ID
- 1607
- Status last verified
- Apr 2023
- First submitted
- 21 Aug 2008
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SynchroMed II Programmable Drug Infusion System Post-Approval Study
- ClinicalTrials.gov ID
- NCT00773019
- Acronym / sponsor ID
- 1607
- Conditions
- Severe Spasticity, Chronic Pain
- Keywords
- infusion pump, implantable, performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 16 Oct 2008 (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.
This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers. Subjects are selected from those evaluated and planning to receive a SynchroMed II drug infusion system for treatment of severe spasticity or chronic pain. Subjects must return for refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically necessary refills. Information is collected on all refills and adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects planning to receive a new or replacement drug pump.
Key inclusion criteria (5 listed)
- Have chronic intractable severe spasticity or chronic pain requiring intrathecal delivery of medication
- Have undergone a pre-implant assessment and determined to be an appropriate candidate for implantation of an infusion system
- Be geographically stable and willing to return to the study center for follow-up visits
- Subject, or subject's legal representative, has signed informed consent form prior to any study-related procedures
- Age is at least 18 years of age at time of enrollment
Key exclusion criteria (5 listed)
- Have a condition in which the pump cannot be implanted 2.5 cm or less from the surface of the skin
- Have an ongoing infection prior to implant
- Have insufficient body mass to accept the pump bulk and weight
- Are unable or unwilling to adhere to the study protocol
- Have an estimated life expectancy of less than twelve months
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 |
|---|---|---|
| Refills (SynchroMed® II Programmable Drug Infusion Pump)Refill information at 1, 6, and 12 months post-implant, as well as any additional refills required from implant through end of study. Amount removed from the pump (taken from syringe), Amount placed in the pump (from syringe),Pump predicted amount remaining in the pump. | Device | – |
Primary outcome
Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed
Time frame: six months
1 secondary outcome
Characterize adverse events experienced with the drug infusion system
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Spasticity and Chronic Pain, run by MedtronicNeuro.
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 5 inclusion and 5 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed (time frame: six 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 27 Apr 2023.