N/A
Completed N=40
Surgical Theater's Surgery Rehearsal Platform
Cerebral Aneurysm Unruptured · Cerebral Aneurysm Ruptured
Source: ClinicalTrials.gov NCT02099318 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Aneurysm Clip Time
Summary
Objectives: The objective of this clinical study is to determine if the use of the SRP will lead to improved effort and time efficiency in cerebral aneurysm surgery. For this preliminary study, the investigators will assess key time and effort variables associated with prospectively assessed SRP neurosurgery cases in comparison with cases with no SRP rehearsal. This is a single site study with one enrolling site. This study will include a total of 40 cases 20 SRP cases and 20 control cases). SRP and control cases will be randomly selected according to a predetermined alternating sequence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aneurysm Clip Time |
— | — |
| SECONDARY Number of Trial Aneurysm Clips Used But Not Implanted |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation for which craniotomy and microsurgery is recommended
- Patients scheduled to undergo surgery for clipping of a cerebral aneurysm, per a.
- Able to provide written informed consent
Exclusion Criteria
- Repeat of aneurysm surgery
- Previous history of craniotomy for any reason
- Previous history of non-aneurysmal hemorrhagic stroke
- Pregnancy
- Posterior circulation
- Giant (25 mm or larger) aneurysm
- Nonsaccular aneurysm
Data sourced from ClinicalTrials.gov (NCT02099318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.