Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000250538p
Ethics application status
Submitted, not yet approved
Date submitted
9/02/2024
Date registered
14/03/2024
Date last updated
14/03/2024
Date data sharing statement initially provided
14/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study Investigating the Coolio System for Pain Management in Patients with Osteoarthritis of the Knee
Scientific title
An Open-Label, Non-Randomized Study Investigating the Coolio System (BXT-786 3.0 Device): A Novel Approach for Managing Knee Pain in Osteoarthritis through Cold Energy Regional Analgesic Block
Secondary ID [1] 311505 0
BXT-786-KPM-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 332840 0
Pain management 332841 0
Condition category
Condition code
Musculoskeletal 329557 329557 0 0
Osteoarthritis
Anaesthesiology 329736 329736 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Coolio System is a medical device that consists of syringes pre-filled with Neural Ice (non-pharmaceutical). Neural Ice is an injectate that relies on a physical mechanism of action, where cold temperatures are used to impact a nerve.
This study will require an anesthesiologist-investigator to inject Neural Ice into three target locations around the knee in patients experiencing pain from osteoarthritis. The three target locations that Neural Ice will be injected into are the superolateral, superomedial, and inferomedial genicular nerves. Each injection site will receive 20mL of Neural Ice. The intervention is expected to take less than 15 minutes. The eCRF will include a genicular block procedure page where coordinators will document whether each step of the intervention was adhered to.
The study will evaluate whether the Coolio System reduces pain associated with osteoarthritis of the knee through the assessment of pain scores and functional tests.
Materials that will be used during the intervention include syringes pre-filled with Neural Ice, injection needles, extension tubing, and Luer connectors.
This intervention will only be administered to each subject once throughout the study in a procedure room located in the pain management clinic.
Subjects will be followed for a total of 6 months, with weekly follow-up visits with the investigator.
Intervention code [1] 327956 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337351 0
To evaluate any adverse events that may occur from the point of administration of Coolio Neural Ice through the subject's final study assessment.
Timepoint [1] 337351 0
Adverse events will be evaluated weekly throughout the 6-month follow-up period.
Secondary outcome [1] 431528 0
Change in pain scores
Timepoint [1] 431528 0
daily for 12 weeks following the intervention, then weekly until 24 weeks following the intervention (study end).
Secondary outcome [2] 431529 0
Change in functional mobility.
Timepoint [2] 431529 0
daily for 12 weeks following the intervention, then weekly until 24 weeks following the intervention (study end).
Secondary outcome [3] 431530 0
Knee Symptoms and Pain
Timepoint [3] 431530 0
weekly for 24 weeks following the intervention.
Secondary outcome [4] 431531 0
Change in range of motion
Timepoint [4] 431531 0
4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks following intervention.
Secondary outcome [5] 431532 0
Change in functional activity.
Timepoint [5] 431532 0
Weekly for 24 weeks following the intervention.
Secondary outcome [6] 431533 0
Patient perception of intervention
Timepoint [6] 431533 0
6 weeks, 12 weeks, 18 weeks, and 24 weeks following intervention.
Secondary outcome [7] 431534 0
Identifying time to onset of Coolio
Timepoint [7] 431534 0
Evaluated daily for 12 weeks following the intervention, and then weekly until 24 weeks following the intervention (study end).
Secondary outcome [8] 431535 0
Identifying block duration of action of Coolio
Timepoint [8] 431535 0
Evaluated daily for 12 weeks following the intervention, and then weekly until 24 weeks following the intervention (study end).

Eligibility
Key inclusion criteria
- Baseline pain intensity of at least 5 on the Numeric Rating Scale (NRS), despite current treatment
- A decrease of at least 50% from baseline Numeric Rating Scale (NRS) with diagnostic genicular nerve block
- Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, 4) on plain x-rays
- Failed conservative treatments (NSAIDs, acetaminophen, physical therapy, and cortisone injections).
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of cryoglobulinemia
- History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
- History of cold urticaria
- History of Chilblain’s (pernio) disease in the lower extremities
- History of Raynaud’s disease
- Currently taking >60 MME/day, as determined per opioid conversion calculator
- Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index knee within the past 12 months
- Use of intra-articular injection of corticosteroid, hyaluronic acid, prolotherapy, autologous blood, or platelet rich plasma injections for the index knee within the previous 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2024
Actual
Date of last participant enrolment
Anticipated
25/05/2024
Actual
Date of last data collection
Anticipated
25/11/2024
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315795 0
Other
Name [1] 315795 0
Brixton Biosciences
Country [1] 315795 0
United States of America
Primary sponsor type
Other
Name
Brixton Biosciences
Address
Country
United States of America
Secondary sponsor category [1] 317921 0
None
Name [1] 317921 0
Address [1] 317921 0
Country [1] 317921 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314653 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 314653 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 314653 0
Australia
Date submitted for ethics approval [1] 314653 0
06/02/2024
Approval date [1] 314653 0
Ethics approval number [1] 314653 0

Summary
Brief summary
The primary objective of the proposed study is to evaluate the safety and tolerability of the Coolio System when administered as a genicular nerve block for pain management in subjects with osteoarthritis of the knee. The secondary objective of the study is to observe analgesic performance of the device.
The Coolio System intends to utilize cold temperatures to temporarily inhibit nerve signaling through the injection of Neural Ice into the extra-neural space of target sensory nerves.
Brixton Biosciences hypothesizes that the injection of Neural Ice around three genicular nerves in the knee can reduce knee pain associated with osteoarthritis. The anesthesiologist-investigator will inject Neural Ice around these three nerves and evaluate pain scores and other assessments throughout a 6-month follow-up period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132294 0
Dr Murray Taverner
Address 132294 0
Frankston Pain Management, 20 Clarendon Street, Suite 7, Frankston, Victoria 3199
Country 132294 0
Australia
Phone 132294 0
+61 417 504 235
Fax 132294 0
Email 132294 0
mgtaverner@gmail.com
Contact person for public queries
Name 132295 0
Sean Taverner
Address 132295 0
Frankston Pain Management, 20 Clarendon Street, Suite 7, Frankston, Victoria 3199
Country 132295 0
Australia
Phone 132295 0
+61 417 504 100
Fax 132295 0
Email 132295 0
research@fpmx.com.au
Contact person for scientific queries
Name 132296 0
Dr. Murray Taverner
Address 132296 0
Frankston Pain Management, 20 Clarendon Street, Suite 7, Frankston, Victoria 3199
Country 132296 0
Australia
Phone 132296 0
+61 417 504 235
Fax 132296 0
Email 132296 0
research@fpmx.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.