Pain, CervicalPhase 2/3DISCOCERVNCT05969392
Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain
A Phase 2/3 study testing Intradiscal Gelified Ethanol (Discogel) in people with Pain, Cervical and Discogenic Pain, run by Gelscom SAS at 2 sites in Italy.
Trial summary
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pain, Cervical, Discogenic Pain
- What is being tested?
- Intradiscal Gelified Ethanol (Discogel)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2025to Apr 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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);
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
Santissima Trinità Hospital Ascagliari
Cagliari, 9121
Stefano Marcia, Pr, stemarcia@gmail.com
Azienda Ospedaliera Universitaria
Siena, 53000
Matteo Bellini, Dr, matteo.bellini@icloud.com
Chiara Zini, zini.chiara@gmail.com
About this study
Official title: Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
Read the detailed description
After being informed about the study and potential tisks, all patients giving written informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry. At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months
- Conditions
- Pain, Cervical, Discogenic Pain
- Being tested
- Intradiscal Gelified Ethanol (Discogel)
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradiscal Gelified Ethanol (Discogel)Device
Intradiscal percutaneous injection of an intradiscal Gelified Ethanol
| Study group | Role | What they receive |
|---|---|---|
| Intradiscal Gelified Ethanol Arm | Experimental | Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria. Receives: Device: Intradiscal Gelified Ethanol (Discogel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
Measured: 3 months
Secondary outcomes (5)
Change in pain cervical intensity using the verbal local rating scale [
Scores range from 0-10. In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
Measured: 12 months
Change of consumption of painkillers
Number, frequency and dosage of pain relief treatments will be combine todescribe the difference in painkiller consumption before and after the operation
Measured: 12 months
Incidence of complication and adverse event rates
Incidence of adverse event during 12 months after the treatment
Measured: 12 months
Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].
The Neck Disability Index (NDI) is used to measure pain-related disability associated with activities of daily living in people with neck pain (index between 0 and 50). The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability, 5 - 14 = mild, 15 - 24 = moderate, 25 - 34 = severe, above 34 = complete. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration.
Measured: 12 months
Subjective evaluation MacNab
The MacNab's scale is layered into 4 levels (excellent, good, fair and poor) according to the patient's well-being after surgery or procedure.The scores were divided into the following four grades: 75-100% (excellent), 50-74% (good), 25-49% (fair) and 0-24% (poor). "Excellent" is defined as "No pain; no restriction of activity". "Good" is defined as "Occasional pain of sufficient severity to interfere with the patient's ability to do his normal work or his capacity to enjoy himself in leisure hours".
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startApr 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, CervicalStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelscom SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969392
- Sponsor's protocol ID
- CLI01068
- Acronym
- DISCOCERV
- Status last verified
- Mar 2025
- First submitted
- 7 Jul 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential data (Pre-market Study trial)
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.
- ClinicalTrials.gov ID
- NCT05969392
- Acronym / sponsor ID
- DISCOCERV / CLI01068
- Conditions
- Pain, Cervical, Discogenic Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gelscom SASIndustry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- 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 assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
Detailed description
After being informed about the study and potential tisks, all patients giving written informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry. At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intradiscal Gelified Ethanol Arm | Experimental | Device: Intradiscal Gelified Ethanol (Discogel)Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
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 |
|---|---|---|
| Intradiscal Gelified Ethanol (Discogel)Intradiscal percutaneous injection of an intradiscal Gelified Ethanol | Device | Intradiscal Gelified Ethanol Arm |
Primary outcome
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)
Time frame: 3 months
In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
5 secondary outcomes
Change in pain cervical intensity using the verbal local rating scale [
Time frame: 12 months
Change of consumption of painkillers
Time frame: 12 months
Incidence of complication and adverse event rates
Time frame: 12 months
Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].
Time frame: 12 months
Subjective evaluation MacNab
Time frame: 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No. Confidential data (Pre-market Study trial)
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intradiscal Gelified Ethanol (Discogel) in people with Pain, Cervical and Discogenic Pain, run by Gelscom SAS at 2 sites in Italy.
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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 3 months). 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 11 Mar 2025.