Evaluation of Effort and Time Efficiency of Surgical Theater's Surgery Rehearsal Platform (SRP) for Cerebral Aneurysm Clipping Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University Hospital Case Medical Center
Sponsor:
Information provided by (Responsible Party):
Nicholas Bambakidis, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT02099318
First received: March 18, 2014
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Cerebral Aneurysm Unruptured
Cerebral Aneurysm Ruptured
Other: Active SRP cases
Other: Control cases

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Evaluation of Effort and Time Efficiency of Surgical Theater's Surgery Rehearsal

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Aneurysm clip time [ Time Frame: At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position ] [ Designated as safety issue: No ]

    Number of Clipping attempts:

    1. Applying a clip (i.e., closing a clip on the aneurysm)
    2. Removing a clip (i.e., a clip was applied on the aneurysm and then removed)
    3. Adjusting a clip (i.e., the clip was applied on the aneurysm and then opened, adjusted, and closed again).


Secondary Outcome Measures:
  • Number of trial aneurysm clips used but not implanted [ Time Frame: At time of surgery-Time from first clip to contact aneurysm to final clip placement ] [ Designated as safety issue: No ]

    Number of Clips evaluated:

    Defined as clips that were brought in proximity to the aneurysm for evaluation (i.e., were visible in the microscopic field) but were not applied, as observed in the operating microscope's video.



Other Outcome Measures:
  • Temporary clip time [ Time Frame: At time of surgery-Total time (minutes/seconds) of all temporary clip applications to all temporary clip removal ] [ Designated as safety issue: No ]

    Total Number of minutes of temporary clip occlusion:

    Defined as the time the temporary clip is released from the clip applier until the temporary clip is removed. (For several temporary occlusions, a cumulative total of all temporary occlusions and total time of overall temporary occlusion time as observed in the operating microscope's video.)


  • Microsurgical time [ Time Frame: At time of surgery-Total time (minutes/seconds) from aneurysm first seen in video to final clip placement ] [ Designated as safety issue: No ]

    Number of minutes of total microsurgical time:

    Defined as the time elapsed from the time the aneurysm was first observed in the OR microscope until the time that the final clip was applied


  • Wasted number of aneurysm clips [ Time Frame: At time of surgery-Time from first aneurysm clip attempt to final clip placement ] [ Designated as safety issue: No ]
    Number of of aneurysm clips wasted according to OR records.


Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active SRP cases
SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.
Other: Active SRP cases

The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.

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
  • 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
Other Names:
  • Trade name: Surgical Rehearsal Platform
  • Regulation Number: 21 CFR 892.2040
  • Regulation Name: Picture Archiving and Commuications System
  • Regulatory Class: II
  • Product Code: LLZ
Placebo Comparator: Control cases
Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Other: Control cases
Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099318

Contacts
Contact: Nicholas C Bambakidis, MD 216-844-8758 nicholas.bambakidis2@uhhospitals.org
Contact: Valerie Cwiklinski, RN, BSN 216-983-5144 valerie.cwiklinski1@uhhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nicholas C Bambakidis, MD    216-844-8756    nicholas.bambakidis2@uhhospitals.org   
Contact: Valerie Cwiklinski, RN, BSN    216-983-5144    valerie.cwiklinski1@uhhospitals.org   
Principal Investigator: Nicholas C Bambakidis, MD         
Sub-Investigator: Warren R Selman, MD         
Sub-Investigator: Alan S Hoffer, MD         
Sponsors and Collaborators
University Hospital Case Medical Center
Investigators
Principal Investigator: Nicholas C Bambakidis, MD University Hospital Case Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Nicholas Bambakidis, Director, Cerebrovascular and Skull Based Surgery, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT02099318     History of Changes
Other Study ID Numbers: 11-12-19, 14308-01-P0195-50392
Study First Received: March 18, 2014
Last Updated: October 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Rehearsal Platform

Additional relevant MeSH terms:
Aneurysm
Aneurysm, Ruptured
Intracranial Aneurysm
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014