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

NCT07757113 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-11

No results posted yet for this study

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

Interventions

DEVICE

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

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

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.

Sponsors & Collaborators

  • phenox Inc.

    collaborator INDUSTRY

  • Sanford Health

    lead OTHER

Principal Investigators

  • Divyajot Sandhu, MD, MBBS · Sanford Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2028-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757113 on ClinicalTrials.gov