Chronic Subdural HematomaNCT07757113
Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization
A study testing Particles (polyvinyl alcohol or similar microspheres), Liquid Embolics (Onyx, n-BCA, or equivalent) and Phenox Coils (Avenir UNO Helical Coil) in people with Chronic Subdural Hematoma and Stroke, run by Sanford Health at 1 site in United States.
Trial summary
Single site, prospective, comparative effectiveness pilot trial comparing efficacy and safety outcomes of three embolic materials (particles, liquid embolics, and Wallaby Phenox coils) in MMA embolication for cSDH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Stroke, Middle Meningeal Artery Embolization
- What is being tested?
- Particles (polyvinyl alcohol or similar microspheres), Liquid Embolics (Onyx, n-BCA, or equivalent) and Phenox Coils (Avenir UNO Helical Coil)
- 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
- Sep 2026to Mar 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years)
- Undergoing Middle Meningeal Artery Embolization (MMAE) for chronic subdural hematoma (cSDH)
- Able to provide informed consent or have a legally authorized representative (LAR) do so
Who cannot join
- Ineligible for MMAE procedure, as deemed by the treating physician, for any indication (e.g. pregnancy)
- Non-chronic subdural hematoma (cSDH) indications for Middle Meningeal Artery Embolization (MMAE), including acute subdural hematoma with symptom onset < 72 hours or mixed acute/chronic without predominant chronic features
- Pregnancy or breastfeeding
- Known severe allergy or contraindication to embolic materials (e.g. particles, liquids like Onyx/n-BCA, or coils)
- Inability to undergo angiography (e.g. severe renal impairment contraindicating contrast)
- Inability or unwillingness to complete follow-up visits at 30 and 90 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sanford USD Medical Center
Sioux Falls, South Dakota, 57105
About this study
Single site, prospective, comparative effectiveness pilot trial comparing efficacy and safety outcomes of three embolic materials (particles, liquid embolics, and Wallaby Phenox coils) in MMA embolication for cSDH.
Read the detailed description
Participants will be sequentially enrolled into one of three treatment arms based on the embolic material used during their MMA embolization:
Cohort/Arm 1: Particles (polyvinyl alcohol or similar microspheres) Cohort/Arm 2: Liquid embolics (Onyx, n-BCA, or equivalent) Cohort/Arm 3: Phenox coils (Avenir UNO Helical Coil) Participants will remain on study through their standard 30- and 90-day follow-up visits.
With a target of 30 patients (10 per arm), the study will provide preliminary data on radiographic efficacy (primary: hematoma resolution/thickness reduction), safety (complications, recurrence, adverse events, reinterventions), and exploratory outcomes (symptom/functional improvement, procedural metrics, influence of comorbidities/antithrombotics).
- Being tested
- Particles (polyvinyl alcohol or similar microspheres), Liquid Embolics (Onyx, n-BCA, or equivalent), Phenox Coils (Avenir UNO Helical Coil)
- Medical subject headings
- Hematoma, Subdural, Chronic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Particles (polyvinyl alcohol or similar microspheres)Device
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
Liquid Embolics (Onyx, n-BCA, or equivalent)Device
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
Phenox Coils (Avenir UNO Helical Coil)Device
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| MMA Embolization | Experimental | Participants will be sequentially assigned one of three MMAE treatment strategies (particles, liquid embolics, or coils) in the order they become eligible and agree to participate. Radiographic and clinical outcomes will be compared. Receives: Device: Particles (polyvinyl alcohol or similar microspheres); Device: Liquid Embolics (Onyx, n-BCA, or equivalent); Device: Phenox Coils (Avenir UNO Helical Coil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hematoma size
The primary objective aims to compare the radiographic efficacy of three embolic materials (particles, liquid embolics, Phenox coils) in MMA embolization for cSDH to evaluate change in hematoma size.
Measured: Baseline, 90 days
Secondary outcomes (4)
Complications
The secondary objectives aim to evaluate the safety profile of the embolic materials, to support overall comparative effectiveness.
Measured: Baseline, 90 days
Recurrence Rates
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
Measured: Baseline, 90 days
Adverse Events
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
Measured: Baseline, 90 days
Re-Intervention Rates
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
Measured: Baseline, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Collaborators
- phenox Inc.
- Responsible party
- Sponsor
- Investigators
- Divyajot Sandhu, MD, MBBS, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757113
- Sponsor's protocol ID
- SH-PHENOX-COILS-MMA-EMBOLICS
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization
- ClinicalTrials.gov ID
- NCT07757113
- Acronym / sponsor ID
- SH-PHENOX-COILS-MMA-EMBOLICS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Collaborators
- phenox Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 11 Aug 2026 (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.
Single site, prospective, comparative effectiveness pilot trial comparing efficacy and safety outcomes of three embolic materials (particles, liquid embolics, and Wallaby Phenox coils) in MMA embolication for cSDH.
Detailed description
Participants will be sequentially enrolled into one of three treatment arms based on the embolic material used during their MMA embolization:
Cohort/Arm 1: Particles (polyvinyl alcohol or similar microspheres) Cohort/Arm 2: Liquid embolics (Onyx, n-BCA, or equivalent) Cohort/Arm 3: Phenox coils (Avenir UNO Helical Coil) Participants will remain on study through their standard 30- and 90-day follow-up visits.
With a target of 30 patients (10 per arm), the study will provide preliminary data on radiographic efficacy (primary: hematoma resolution/thickness reduction), safety (complications, recurrence, adverse events, reinterventions), and exploratory outcomes (symptom/functional improvement, procedural metrics, influence of comorbidities/antithrombotics).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MMA Embolization | Experimental | Device: Particles (polyvinyl alcohol or similar microspheres), Device: Liquid Embolics (Onyx, n-BCA, or equivalent), Device: Phenox Coils (Avenir UNO Helical Coil)Participants will be sequentially assigned one of three MMAE treatment strategies (particles, liquid embolics, or coils) in the order they become eligible and agree to participate. Radiographic and clinical outcomes will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥ 18 years)
- Undergoing Middle Meningeal Artery Embolization (MMAE) for chronic subdural hematoma (cSDH)
- Able to provide informed consent or have a legally authorized representative (LAR) do so
Key exclusion criteria (6 listed)
- Ineligible for MMAE procedure, as deemed by the treating physician, for any indication (e.g. pregnancy)
- Non-chronic subdural hematoma (cSDH) indications for Middle Meningeal Artery Embolization (MMAE), including acute subdural hematoma with symptom onset < 72 hours or mixed acute/chronic without predominant chronic features
- Pregnancy or breastfeeding
- Known severe allergy or contraindication to embolic materials (e.g. particles, liquids like Onyx/n-BCA, or coils)
- Inability to undergo angiography (e.g. severe renal impairment contraindicating contrast)
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 |
|---|---|---|
| Particles (polyvinyl alcohol or similar microspheres)Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes. | Device | MMA Embolization |
| Liquid Embolics (Onyx, n-BCA, or equivalent)Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes. | Device | MMA Embolization |
| Phenox Coils (Avenir UNO Helical Coil)Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes. | Device | MMA Embolization |
Primary outcome
Change in hematoma size
Time frame: Baseline, 90 days
The primary objective aims to compare the radiographic efficacy of three embolic materials (particles, liquid embolics, Phenox coils) in MMA embolization for cSDH to evaluate change in hematoma size.
4 secondary outcomes
Complications
Time frame: Baseline, 90 days
Recurrence Rates
Time frame: Baseline, 90 days
Adverse Events
Time frame: Baseline, 90 days
Re-Intervention Rates
Time frame: Baseline, 90 days
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 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Divyajot Sandhu, MD, MBBS principal investigator
Sanford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Particles (polyvinyl alcohol or similar microspheres), Liquid Embolics (Onyx, n-BCA, or equivalent) and Phenox Coils (Avenir UNO Helical Coil) in people with Chronic Subdural Hematoma and Stroke, run by Sanford Health 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 3 inclusion and 6 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 Aug 2026. 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?
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?
Contact Alycia Abler Clinical Research Project Manager ((701) 417-2002, alycia.abler@sanfordhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hematoma size (time frame: Baseline, 90 days). 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 Aug 2026.