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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05969392




Registration number
NCT05969392
Ethics application status
Date submitted
7/07/2023
Date registered
1/08/2023
Date last updated
1/10/2024

Titles & IDs
Public title
Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain
Scientific title
Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.
Secondary ID [1] 0 0
CLI01068
Universal Trial Number (UTN)
Trial acronym
DISCERV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Cervical 0 0
Discogenic Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Intradiscal Gelified Ethanol

Experimental: Intradiscal Gelified Ethanol Arm - Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria.


Treatment: Devices: Intradiscal Gelified Ethanol
Intradiscal percutaneous injection of an intradiscal Gelified Ethanol
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months)
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Change in pain cervical intensity using the verbal local rating scale [
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Change of consumption of painkillers
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Incidence of complication and adverse event rates
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Subjective evaluation MacNab
Timepoint [5] 0 0
12 months after treatment

Eligibility
Key inclusion criteria
* Patient 18 years or older;
* Pain refractory to conservative treatments for more than 2 months, non-surgical patients
* Cervicobrachialgia due to disc herniation
* Chronic discogenic pain (1 or 2 cervical discs) with concordant MRI;
* Patient agreeing to participate in the study and having given written consent;
* Patient enrolled in a health insurance plan.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior surgical treatment of the disc(s) studied;
* Sick leave of more than 12 months secondary to painful symptoms;
* Patient with Modic 1 score or more
* History of cognitive-behavioral disorders that could affect the completion of self-questionnaires;
* Local or systemic infection, or suspicion of infection;
* Severe coagulation disorders;
* Other inflammatory rheumatic disease;
* Severe underlying pathology with life expectancy <1 year;
* Women of childbearing age who are pregnant at the inclusion visit or who wish to become pregnant before the administration of the treatment (V0);
* Known allergy to contrast material and/or local anesthetic substances;
* Patients who cannot read or write Italian;
* Major person benefiting from a legal protection regime (guardianship, curatorship, safeguard of justice);

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Cagliari
Country [2] 0 0
Italy
State/province [2] 0 0
Siena

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gelscom SAS
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
Trial website
https://clinicaltrials.gov/study/NCT05969392
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05969392