Peripheral Nerve BlocksNCT02614222
Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks
A study testing Peripheral Nerve Blocks with CAIG in people with Peripheral Nerve Blocks, run by Clear Guide Medical at 1 site in United States.
Trial summary
The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Blocks
- What is being tested?
- Peripheral Nerve Blocks with CAIG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2015to 25 May 2016
- 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
- Undergoing orthopedic surgery who are candidates for peripheral nerve blocks for control of postoperative pain
- Able to give written informed consent
Who cannot join
- Unable to give informed consent
- Patients in whom regional anesthesia is contradicted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer Assisted Instrument Guidance (CAIG) For Orthopedic Peripheral Nerve Blocks
The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician better guide the needle to the target.
Read the detailed description
This pilot study will be a randomized, single-blinded control trial. The clinicians cannot be blinded, but the person questioning the patient post-op to determine success rate will be blinded. There will be two randomized groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
- Conditions
- Peripheral Nerve Blocks
- Being tested
- Peripheral Nerve Blocks with CAIG
- Keywords
- Computer Assisted Instrument Guidance (CAIG), Peripheral Nerve Block, Clear Guide ONE, Needle path, Needle Guidance, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve Blocks with CAIGDevice
Also called Clear Guide ONE
The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Nerve Block with CAIG | Experimental | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. Receives: Device: Peripheral Nerve Blocks with CAIG |
| Peripheral Nerve Block without CAIG | No intervention | The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
Measured: Immediately after intervention (within 2 hours)
Secondary outcomes (7)
Clinician Rating of the Device
Clinician rates the device on a scale of 1-10. This also includes a questionnaire.
Measured: Immediately following intervention (within 2 hours)
Number of Attempts
Number of instrument pricks before target is reached
Measured: Immediately following intervention (within 2 hours)
Number of Times Needle Needs Repositioning
Measured: Immediately following intervention (within 2 hours)
Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire
Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire.
Measured: Post-op day 1
Number of Patients That Needed Rescue Opioids
Measured: During hospital stay (maximum 3 days)
Incidence of Postoperative Nausea and Vomiting
Number of participants that reported postoperative nausea and vomiting
Measured: During hospital stay (maximum 3 days)
Undesired Muscle Weakness Measured Subjectively
Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer.
Measured: During hospital stay (maximum 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start26 Oct 2015
- Primary completion25 May 2016
- Study completion25 May 2016
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 Peripheral Nerve BlocksStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Guide Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cooper Health System
- Responsible party
- Sponsor
- Investigators
- Ronak Desai, DO, Principal investigator, The Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614222
- Sponsor's protocol ID
- CGM 15-002
- Status last verified
- Jun 2017
- First submitted
- 19 Nov 2015
- Last updated
- 7 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Instrument Guidance (CAIG) For Orthopedic Peripheral Nerve Blocks
- ClinicalTrials.gov ID
- NCT02614222
- Acronym / sponsor ID
- CGM 15-002
- Conditions
- Peripheral Nerve Blocks
- Keywords
- Computer Assisted Instrument Guidance (CAIG), Peripheral Nerve Block, Clear Guide ONE, Needle path, Needle Guidance, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Clear Guide MedicalIndustry (pharma, biotech, devices)
- Collaborators
- The Cooper Health System
- Study start
- 26 Oct 2015
- Primary completion
- 25 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician better guide the needle to the target.
Detailed description
This pilot study will be a randomized, single-blinded control trial. The clinicians cannot be blinded, but the person questioning the patient post-op to determine success rate will be blinded. There will be two randomized groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral Nerve Block with CAIG | Experimental | Device: Peripheral Nerve Blocks with CAIGThe participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. |
| Peripheral Nerve Block without CAIG | No intervention | –The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing orthopedic surgery who are candidates for peripheral nerve blocks for control of postoperative pain
- Able to give written informed consent
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Patients in whom regional anesthesia is contradicted
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 |
|---|---|---|
| Peripheral Nerve Blocks with CAIGAlso: Clear Guide ONEThe Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure. | Device | Peripheral Nerve Block with CAIG |
Primary outcome
Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
Time frame: Immediately after intervention (within 2 hours)
7 secondary outcomes
Clinician Rating of the Device
Time frame: Immediately following intervention (within 2 hours)
Number of Attempts
Time frame: Immediately following intervention (within 2 hours)
Number of Times Needle Needs Repositioning
Time frame: Immediately following intervention (within 2 hours)
Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire
Time frame: Post-op day 1
Number of Patients That Needed Rescue Opioids
Time frame: During hospital stay (maximum 3 days)
Incidence of Postoperative Nausea and Vomiting
Time frame: During hospital stay (maximum 3 days)
Undesired Muscle Weakness Measured Subjectively
Time frame: During hospital stay (maximum 3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ronak Desai, DO principal investigator
The Cooper Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Nerve Blocks with CAIG in people with Peripheral Nerve Blocks, run by Clear Guide Medical 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 2 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 Jul 2017. 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 14 Jun 2017). 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?
Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block (time frame: Immediately after intervention (within 2 hours)). 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 Jul 2017.