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N/A N=40 Randomized Double-blind Other

Surgical Theater's Surgery Rehearsal Platform

Cerebral Aneurysm Unruptured · Cerebral Aneurysm Ruptured

Bottom Line

View on ClinicalTrials.gov: NCT02099318 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Aneurysm Clip Time

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Active SRP cases (Other); Control cases (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University Hospitals Cleveland Medical Center
Primary completion
Sep 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Aneurysm Clip Time		 — —
SECONDARY
Number of Trial Aneurysm Clips Used But Not Implanted		 — —

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.

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
View full record on ClinicalTrials.gov →

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.

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