Trial Outcomes & Findings for Surgical Theater's Surgery Rehearsal Platform (NCT NCT02099318)
NCT ID: NCT02099318
Last Updated: 2017-05-05
Results Overview
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).
COMPLETED
NA
40 participants
At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position(up to 5 minutes)
2017-05-05
Participant Flow
Participant milestones
| Measure |
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 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
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 Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgical Theater's Surgery Rehearsal Platform
Baseline characteristics by cohort
| Measure |
Active SRP Cases
n=20 Participants
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
n=20 Participants
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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Number
n=99 Participants
|
0 Number
n=107 Participants
|
0 Number
n=206 Participants
|
|
Age, Customized
Between 18 and 65 years
|
16 Number
n=99 Participants
|
15 Number
n=107 Participants
|
31 Number
n=206 Participants
|
|
Age, Customized
>=65 years
|
4 Number
n=99 Participants
|
5 Number
n=107 Participants
|
9 Number
n=206 Participants
|
|
Age, Continuous
|
52 years
n=99 Participants
|
52 years
n=107 Participants
|
52 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position(up to 5 minutes)Population: Data was lost; no results can be reported
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At time of surgery-Time (minutes/seconds) from first clip to contact aneurysm to final clip placementPopulation: Data was lost; no results can be reported
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of surgery-Total time (minutes/seconds) of all temporary clip applications to all temporary clip removalPopulation: Data was lost; no results can be reported
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.)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of surgery-Total time (minutes/seconds) from aneurysm first seen in video to final clip placementPopulation: Data was lost; no results can be reported
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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of surgery-Time (minutes/seconds) from first aneurysm clip attempt to final clip placementPopulation: Data was lost; no results can be reported
Number of of aneurysm clips wasted according to OR records.
Outcome measures
Outcome data not reported
Adverse Events
Active SRP Cases
Control Cases
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Valerie Cwiklinski Clinical Research Nurse
University Hospitals Cleveland Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place