NCT07250958

Brief Summary

The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Jan 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

November 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

November 18, 2025

Last Update Submit

December 9, 2025

Conditions

Aneurysmal Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Re-rupture incidence

    Detected on head CT

    From procedure to 90-days post procedure.

Secondary Outcomes (3)

  • Functional Outcome

    90 days (+-14 days) post procedure

  • Accomplishment of Dome protection

    From procedure through 90-days post procedure

  • Procedural complications during the dome-protection and delayed final procedures on the aneurysm

    Time of procedure through 90 days post procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18 years or older with CT confirmed aSAH with an angiographically detected aneurysm

You may qualify if:

  • years or older
  • CT confirmed aSAH with an angiographically detected aneurysm
  • World Federation of Neurological Sciences (WFNS) aSAH grade 3-5 aneurysm
  • LAR available and gives consent within 72 hours after the onset of aSAH (or last known normal

You may not qualify if:

  • Patients whose aneurysm judged appropriate for balloon-assisted coiling
  • Patients whose aneurysm is bleeding from the "neck"
  • Patients who are clinically judged to suffer imminent death within 24 hours.
  • Pregnancy or positive urine pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Term

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 26, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

December 15, 2025

Record last verified: 2025-12