Upper LimbPROC2020PMNCT04466111

Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain

An observational study of Upper Limb and Pain, run by SGX Procura LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach. Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Upper Limb, Pain
What is being tested?: Intellis neurostimulator system
Type of treatment: Medical device
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 8 Sep 2020to 9 Mar 2023
Phase: Observational
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

Study population: The intended study population is individuals who have been diagnosed with chronic, intractable pain of the upper limbs associated with a number of conditions, and who the Principal Investigator deems is an appropriate candidate for SCS therapy as required for this study.

Who may be able to join

A subject must MEET ALL of the following inclusion criteria:
Be diagnosed with chronic, intractable pain of the upper limb related to the cervical spine and/or neuropathic arm pain.
Be a candidate for SCS system (trial and implant) per labeled indication (upper limb pain due to one of the conditions listed in indications statement)
Considering daily activity and rest, has average upper limb pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at 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.

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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, including not increasing pain meds through the three month visit
Has adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator

Who cannot join

A subject must NOT MEET ANY of the following exclusion criteria:
Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the study manager or designee)
Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump.
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

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Has significant cervical stenosis, as determined by the Investigator
Has facet spondylosis, as determined by the Investigator
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 upper limb pain, which is providing significant pain relief
Has unresolved major issues of secondary gain (e.g., social, financial, legal, such as worker compensation matters)
Be pregnant as 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.
Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist
Have a current diagnosis of a progressive neurological disease as determined by the Investigator
Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
Have a condition that the Investigator determines would significantly increase perioperative risk
Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) of the cervical spine
Have metastatic malignant disease or active local malignant disease
Have a life expectancy of less than 1 year
Have an active systemic or local infection
Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)

Trial locations and contacts

1 site in 1 country.

United States1 site

SGX Medical
Bloomington, Illinois, 61704

Other trials in United States

About this study

Official title: A Post-Market, Observational Clinical Study to Evaluate the Effects of Differential Target Multiplexed DTM™ SCS Programming in Treating Intractable Chronic Upper Extremity Limb Pain

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach.

Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

Read the detailed description

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach.

Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

The expected total duration of this study is approximately 26 months. Enrollment of participants is expected to last 20 months. Participants that have received the permanent implant will be followed up for 12 months after their device has been activated. A participant will likely be committed to the study for about 14 months. This consists of Baseline assessments, up to 10 days of trial stimulation, and 12 months of treatment following implantation and activation of the device. All subjects who plan on remaining implanted through the 6-month visit or who have completed their 6-month visit will be offered to return for an additional 12-month visit. This would increase their commitment to the study to 14 months.

Conditions: Upper Limb, Pain
Being tested: Intellis neurostimulator system
Keywords: upper limb, Spinal Cord Stimulation, Pain
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intellis neurostimulator systemDevice
Also called Spinal Cord Stimulation (SCS) device system
The study will use the commercially available IntellisTM neurostimulator and compatible SCS system components from Medtronic using stimulation parameters within the specifications approved for use in the approved indications. The study will stimulate the cervical dorsal columns of the spinal cord.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Implanted Subjects Who Respond to DTM SCS Therapy at 3-months
The primary efficacy endpoint is the percentage of implanted subjects who respond to DTM SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in upper limb pain relative to baseline assessment.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 20209 Mar 2023

First posted10 Jul 2020
Study start8 Sep 2020
Primary completion29 Jul 2022
Study completion9 Mar 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 Upper LimbStudies 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: Other
Time perspective: Prospective
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04466111
Sponsor's protocol ID: DTM-PROC-2020PM3
Acronym: PROC2020PM
Status last verified: Mar 2024
First submitted: 6 Jul 2020
Last updated: 19 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Upper Limb trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Market, Observational Clinical Study to Evaluate the Effects of Differential Target Multiplexed DTM™ SCS Programming in Treating Intractable Chronic Upper Extremity Limb Pain
ClinicalTrials.gov ID: NCT04466111
Acronym / sponsor ID: PROC2020PM / DTM-PROC-2020PM3
Conditions: Upper Limb, Pain
Keywords: upper limb, Spinal Cord Stimulation, Pain
Study type: Observational
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: SGX Procura LLCIndustry (pharma, biotech, devices)
Study start: 8 Sep 2020 (actual)
Primary completion: 29 Jul 2022 (actual)
Study completion: 9 Mar 2023 (actual)
First posted: 10 Jul 2020 (actual)
Results: Posted 19 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach.

Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

Detailed description

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach.

Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The intended study population is individuals who have been diagnosed with chronic, intractable pain of the upper limbs associated with a number of conditions, and who the Principal Investigator deems is an appropriate candidate for SCS therapy as required for this study.

Key inclusion criteria (10 listed)

A subject must MEET ALL of the following inclusion criteria:

Key exclusion criteria (21 listed)

A subject must NOT MEET ANY of the following exclusion criteria:

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
Intellis neurostimulator systemAlso: Spinal Cord Stimulation (SCS) device systemThe study will use the commercially available IntellisTM neurostimulator and compatible SCS system components from Medtronic using stimulation parameters within the specifications approved for use in the approved indications. The study will stimulate the cervical dorsal columns of the spinal cord.	Device	–

Primary outcome

Percentage of Implanted Subjects Who Respond to DTM SCS Therapy at 3-months
Time frame: 3 months
The primary efficacy endpoint is the percentage of implanted subjects who respond to DTM SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in upper limb pain relative to baseline assessment.

Results and safety

Results posted to the registry on 19 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Treated With DTM SCS Programming	58	57

Primary outcome: Percentage of Implanted Subjects Who Respond to DTM SCS Therapy at 3-months

Time frame: 3 months. Number (95% Confidence Interval). Unit: percentage of individual responder

Measure	Subjects Treated With DTM SCS Programming n = 43
Value	100 (91.78 to 100)

Population analysed: All subjects who receive a permanent SCS system implant. Does not include subjects that failed the trial phase nor subjects that did not receive permanent SCS system.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Treated With DTM SCS Programming	1 of 58 (1.7%)	3 of 58 (5.2%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Upper Limb

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Not yet recruiting
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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.

Ricardo Vallejo, MD study chair

SGX Medical

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 Upper Limb and Pain, run by SGX Procura LLC at 1 site in United States.

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 10 inclusion and 21 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 19 Aug 2024. 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 United States. 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 19 Aug 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 Implanted Subjects Who Respond to DTM SCS Therapy at 3-months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04466111.

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 19 Aug 2024.