Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization

NCT07757113 | Not Yet Recruiting FDA Device

• 1 other identifier: SH-PHENOX-COILS-MMA-EMBOLICS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Subdural Hematoma; Stroke; Middle Meningeal Artery Embolization

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 90 days

Secondary Outcomes (4)

• Complications

  Baseline, 90 days

• Recurrence Rates

  Baseline, 90 days

• Adverse Events

  Baseline, 90 days

• Re-Intervention Rates

  Baseline, 90 days

Study Arms (1)

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.

Device: Particles (polyvinyl alcohol or similar microspheres); Device: Liquid Embolics (Onyx, n-BCA, or equivalent); Device: Phenox Coils (Avenir UNO Helical Coil)

Interventions

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.

MMA Embolization

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.

MMA Embolization

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.

MMA Embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanford Health: lead
• phenox Inc.: collaborator

Study Sites (1)

Sanford USD Medical Center

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Stroke

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Divyajot Sandhu, MD, MBBS

  Sanford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alycia Abler Clinical Research Project Manager

CONTACT

(701) 417-2002; alycia.abler@sanfordhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 11, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)