Chronic Lower Limb PainBASMATINCT04672096
Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
A study testing Neuronoff BASMATI Injectrode in people with Chronic Lower Limb Pain, run by Neuronoff, Inc at 1 site in United States.
Trial summary
The objectives of this non-significant risk (NSR) study are to evaluate the safety of the short term placement of the Basmati Injectrode for up to 28 days and the efficacy of conducting electrical current to stimulate subcutaneous nerves on the explant date just prior to explant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Lower Limb Pain
- What is being tested?
- Neuronoff BASMATI Injectrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2020to 21 May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) and understand the study requirements.
- Be 18 years of age or older when written informed consent is obtained.
- Be in good physical and mental health as assessed by a general practitioner.
- Be able to tolerate electrical stimulation (TENS).
- Be willing and able to understand and comply with all study-related procedures during the course of the study.
Who cannot join
- Have a cognitive impairment or exhibit any characteristic that would limit the study candidate's ability to completely understand and sign a valid, IRB-approved informed consent form.
- Have a positive pregnancy test (conducted during enrollment).
- Have a positive Allergic reactivity to Gold skin test (conducted during enrollment).
- Show symptoms indicative for Covid19 as assessed during enrollment.
- Have a skin condition at the planned surgical location.
- Have a blood coagulation disorder or other indication with the potential to impact the study biocompatibility data in unpredictable ways.
Show all 19Show fewer
- Have a medical condition that is a contraindication for minimally invasive surgery.
- Be implanted with a cardiac defibrillator or pump.
- Have a history of cardiac arrhythmia with hemodynamic instability
- Be implanted with a neurostimulator.
- Have any active electrical implant of any other kind.
- Have metal implants (particularly in hip).
- Have active infection.
- Have allodynia.
- Take regular use of antiplatelet medications (e.g. aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat) or eptifibatide (Integrilin)).
- Have untreated drug habituation or dependence.
- Have uncontrolled seizures (averaging > 2 seizures per month).
- Currently require, or be likely to require, diathermy and/or MRI during study duration.
- Have a history of adverse reactions to local anesthetics (e.g. lidocaine).
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this non-significant risk (NSR) study are to evaluate the safety of the short term placement of the Basmati Injectrode for up to 28 days and the efficacy of conducting electrical current to stimulate subcutaneous nerves on the explant date just prior to explant.
Read the detailed description
This was a prospective, single-center, single-arm, non-randomized study design. A sample of 10 study participants were enrolled into the study, and provided with the placement of a Basmati Injectrode insert with a maximal placement duration of up to 28 days. Subjects who were selected to participate in the trial were healthy volunteers adults with ages 18 years and older without any preexisting condition indicated for treatment. Each subject was followed during the trial period of approximately 45+/-2 days.
- Conditions
- Chronic Lower Limb Pain
- Being tested
- Neuronoff BASMATI Injectrode
- Keywords
- Electrode, Injectable Electrode, Injectrode, Medical Device Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuronoff BASMATI InjectrodeDevice
Also called Injectrode, BASMATI Injectrode
The 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation.
| Study group | Role | What they receive |
|---|---|---|
| Neuronoff BASMATI Injectrode | Experimental | Subjects will be provided with the placement of an Injectrode insert. The maximal placement duration will be 28 days. Receives: Device: Neuronoff BASMATI Injectrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis
Primary measures of device safety included verification of the absence of unexpected inflammation and minimization of excessive encapsulation around the Injectrode as verified by cell staining and pathohistological analysis.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start4 Dec 2020
- Primary completion21 May 2021
- Study completion21 May 2021
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 Chronic Lower Limb PainStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronoff, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio Pain Clinic
- Responsible party
- Sponsor
- Investigators
- Amol Soin, MD, Principal investigator, Ohio Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672096
- Sponsor's protocol ID
- NCP-01
- Acronym
- BASMATI
- Status last verified
- Nov 2023
- First submitted
- 4 Dec 2020
- Last updated
- 19 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
- ClinicalTrials.gov ID
- NCT04672096
- Acronym / sponsor ID
- BASMATI / NCP-01
- Conditions
- Chronic Lower Limb Pain
- Keywords
- Electrode, Injectable Electrode, Injectrode, Medical Device Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Neuronoff, IncIndustry (pharma, biotech, devices)
- Collaborators
- Ohio Pain Clinic
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 19 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this non-significant risk (NSR) study are to evaluate the safety of the short term placement of the Basmati Injectrode for up to 28 days and the efficacy of conducting electrical current to stimulate subcutaneous nerves on the explant date just prior to explant.
Detailed description
This was a prospective, single-center, single-arm, non-randomized study design. A sample of 10 study participants were enrolled into the study, and provided with the placement of a Basmati Injectrode insert with a maximal placement duration of up to 28 days. Subjects who were selected to participate in the trial were healthy volunteers adults with ages 18 years and older without any preexisting condition indicated for treatment. Each subject was followed during the trial period of approximately 45+/-2 days.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuronoff BASMATI Injectrode | Experimental | Device: Neuronoff BASMATI InjectrodeSubjects will be provided with the placement of an Injectrode insert. The maximal placement duration will be 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) and understand the study requirements.
- Be 18 years of age or older when written informed consent is obtained.
- Be in good physical and mental health as assessed by a general practitioner.
- Be able to tolerate electrical stimulation (TENS).
- Be willing and able to understand and comply with all study-related procedures during the course of the study.
Key exclusion criteria (19 listed)
- Have a cognitive impairment or exhibit any characteristic that would limit the study candidate's ability to completely understand and sign a valid, IRB-approved informed consent form.
- Have a positive pregnancy test (conducted during enrollment).
- Have a positive Allergic reactivity to Gold skin test (conducted during enrollment).
- Show symptoms indicative for Covid19 as assessed during enrollment.
- Have a skin condition at the planned surgical location.
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 |
|---|---|---|
| Neuronoff BASMATI InjectrodeAlso: Injectrode, BASMATI InjectrodeThe 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation. | Device | Neuronoff BASMATI Injectrode |
Primary outcome
Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis
Time frame: 28 days
Primary measures of device safety included verification of the absence of unexpected inflammation and minimization of excessive encapsulation around the Injectrode as verified by cell staining and pathohistological analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Lower Limb Pain
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
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.
Amol Soin, MD principal investigator
Ohio Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuronoff BASMATI Injectrode in people with Chronic Lower Limb Pain, run by Neuronoff, Inc 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 5 inclusion and 19 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 Apr 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 Apr 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?
Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis (time frame: 28 days). 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 19 Apr 2024.