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Verification of clinical efficacy of surgical planning using 3D printed models of intracranial aneurysms: randomized controlled study

Verification of clinical efficacy of surgical planning using 3D printed models of intracranial aneurysms: randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008646
Enrollment
30
Registered
2023-07-26
Start date
2021-08-18
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Three-dimensional printed intracranial anuerysm model

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) patients diagnosed with a single unruptured IA in the anterior circulation on magnetic resonance angiography or computed tomography angiography and digital subtraction angiography with 3D reconstructed imaging; 2) patients with IAs inappropriate for endovascular intervention in terms of shape, access, underlying medical conditions, and patient preference; 3) patients with a tolerable healthy condition with a Karnofsky Performance Scale = 70 and modified Rankin Scale = 2; and 4) patients who agreed to surgical clipping via keyhole craniotomy

Exclusion criteria

Exclusion criteria: (1) In cases where the researchers determine that an evaluation of effectiveness is not necessary. (2) In cases where the patient or their guardian does not provide consent.

Design outcomes

Primary

MeasureTime frame
Objective indicators (surgical duration, immediate postoperative pain, degree of aneurysm occlusion, length of stay in the intermediate care unit, total hospitalization period, amount of bleeding, etc.).

Secondary

MeasureTime frame
Subjective indicators (survey questionnaire assessing patient description, education, and level of assistance during surgery).

Countries

Korea, Republic of

Contacts

Public ContactSung Ho Lee

Seoul National University Hospital

nssungholee@snu.ac.kr+82-2-2072-1189

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026