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Surgical Theater's Surgery Rehearsal Platform (SRP)

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ClinicalTrials.gov Identifier: NCT02099318
Recruitment Status : Completed
First Posted : March 28, 2014
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Nicholas Bambakidis, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Other
Conditions Cerebral Aneurysm Unruptured
Cerebral Aneurysm Ruptured
Interventions Other: Active SRP cases
Other: Control cases
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active SRP Cases Control Cases
Hide Arm/Group Description

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 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.

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.

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.

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.

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Active SRP Cases Control Cases Total
Hide Arm/Group Description

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 surgery for evaluation of optional surgery approaches.

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 f

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Number
Number Analyzed 20 participants 20 participants 40 participants
<=18 years 0 0 0
Between 18 and 65 years 16 15 31
>=65 years 4 5 9
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
52
(32 to 72)
52
(32 to 72)
52
(32 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
17
  85.0%
15
  75.0%
32
  80.0%
Male
3
  15.0%
5
  25.0%
8
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Aneurysm Clip Time
Hide Description

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).
Time Frame At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position(up to 5 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was lost; no results can be reported
Arm/Group Title Active SRP Cases Control Cases
Hide Arm/Group Description:

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 surgery for evaluation of optional surgery approaches.

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 f

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Trial Aneurysm Clips Used But Not Implanted
Hide Description

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.

Time Frame At time of surgery-Time (minutes/seconds) from first clip to contact aneurysm to final clip placement
Hide Outcome Measure Data
Hide Analysis Population Description
Data was lost; no results can be reported
Arm/Group Title Active SRP Cases Control Cases
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Other Pre-specified Outcome
Title Temporary Clip Time
Hide Description

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.)

Time Frame At time of surgery-Total time (minutes/seconds) of all temporary clip applications to all temporary clip removal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was lost; no results can be reported
Arm/Group Title Active SRP Cases Control Cases
Hide Arm/Group Description:

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 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.

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.

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title Microsurgical Time
Hide Description

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

Time Frame At time of surgery-Total time (minutes/seconds) from aneurysm first seen in video to final clip placement
Hide Outcome Measure Data
Hide Analysis Population Description
Data was lost; no results can be reported
Arm/Group Title Active SRP Cases Control Cases
Hide Arm/Group Description:

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 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.

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.

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Wasted Number of Aneurysm Clips
Hide Description Number of of aneurysm clips wasted according to OR records.
Time Frame At time of surgery-Time (minutes/seconds) from first aneurysm clip attempt to final clip placement
Hide Outcome Measure Data
Hide Analysis Population Description
Data was lost; no results can be reported
Arm/Group Title Active SRP Cases Control Cases
Hide Arm/Group Description:

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 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.

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.

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active SRP Cases Control Cases
Hide Arm/Group Description

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, SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.

Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during 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 w

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.

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.

All-Cause Mortality
Active SRP Cases Control Cases
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Active SRP Cases Control Cases
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active SRP Cases Control Cases
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Valerie Cwiklinski Clinical Research Nurse
Organization: University Hospitals Cleveland Medical Center
Phone: 216-983-5144
Responsible Party: Nicholas Bambakidis, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02099318     History of Changes
Other Study ID Numbers: 11-12-19
14308-01-P0195-50392 ( Other Identifier: 14308-01-P0195-50392 )
First Submitted: March 18, 2014
First Posted: March 28, 2014
Results First Submitted: February 1, 2016
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017