ObesityNCT01811446
Evaluation of Muscle Activation Efficiency in Challenging Subjects
A study testing Muscle Activation with Niveus and Intelect Devices in people with Obesity and COPD, run by Niveus Medical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device. A novel device will be compared side by side with a market leading device. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Muscle Activation with Niveus and Intelect Devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Sep 2013
- Phase
- Interventional
- 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
Who may be able to join
- BMI > 30 (Wing 1 of study)
- Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study)
Who cannot join
- Age < 18 years
- Subject has an implanted pacemaker/defibrillator
- Subject diagnosed with epilepsy
- Subject has implanted metallic femoral rods
- Subject is chair- or bed-bound
- Subject has neuromuscular disease or abnormalities
- Subject BMI > 45
- Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Fogarty Clinical Research
Mountain View, California, 94040
About this study
Official title: Evaluation of Muscle Stimulation Efficiency in Challenging Subjects: A Pilot Study
The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device. A novel device will be compared side by side with a market leading device.
- Being tested
- Muscle Activation with Niveus and Intelect Devices
- Medical subject headings
- Obesity, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Activation with Niveus and Intelect DevicesDevice
Subjects will receive muscle activation technology from the Niveus device on one leg and from the Intelect (commercially-available third-party) device on the other. The order of use and the leg applied to will be randomized.
| Study group | Role | What they receive |
|---|---|---|
| Obese | Experimental | Subjects with BMI > 30 Receives: Device: Muscle Activation with Niveus and Intelect Devices |
| COPD | Experimental | Non-hospitalized COPD patients Receives: Device: Muscle Activation with Niveus and Intelect Devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity Required
Intensity required to achieve target levels of muscle contraction
Measured: During treatment
Secondary outcomes (1)
Comfort
Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niveus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bahman Nouri, MD, Principal investigator, El Camino Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811446
- Sponsor's protocol ID
- CLP-2.00
- Status last verified
- Jan 2014
- First submitted
- 12 Mar 2013
- Last updated
- 31 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Muscle Stimulation Efficiency in Challenging Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT01811446
- Acronym / sponsor ID
- CLP-2.00
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Niveus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- First posted
- 14 Mar 2013 (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.
The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device. A novel device will be compared side by side with a market leading device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | Experimental | Device: Muscle Activation with Niveus and Intelect DevicesSubjects with BMI > 30 |
| COPD | Experimental | Device: Muscle Activation with Niveus and Intelect DevicesNon-hospitalized COPD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 30 (Wing 1 of study)
- Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study)
Key exclusion criteria (8 listed)
- Age < 18 years
- Subject has an implanted pacemaker/defibrillator
- Subject diagnosed with epilepsy
- Subject has implanted metallic femoral rods
- Subject is chair- or bed-bound
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 |
|---|---|---|
| Muscle Activation with Niveus and Intelect DevicesSubjects will receive muscle activation technology from the Niveus device on one leg and from the Intelect (commercially-available third-party) device on the other. The order of use and the leg applied to will be randomized. | Device | COPD, Obese |
Primary outcome
Intensity Required
Time frame: During treatment
Intensity required to achieve target levels of muscle contraction
1 secondary outcome
Comfort
Time frame: During treatment
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 31 Jan 2014.
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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.
Bahman Nouri, MD principal investigator
El Camino Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Activation with Niveus and Intelect Devices in people with Obesity and COPD, run by Niveus Medical, 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 2 inclusion and 8 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 31 Jan 2014. 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?
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?
Intensity Required (time frame: During treatment). 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 31 Jan 2014.