Surgical Theater's Surgery Rehearsal Platform

NCT02099318 | Completed Results

• 2 other identifiers: 11-12-1914308-01-P0195-50392
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Aneurysm Unruptured; Cerebral Aneurysm Ruptured

Keywords

Rehearsal Platform

Outcome Measures

Primary Outcomes (1)

• Aneurysm Clip Time

  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).

  At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position(up to 5 minutes)

Secondary Outcomes (1)

• Number of Trial Aneurysm Clips Used But Not Implanted

  At time of surgery-Time (minutes/seconds) from first clip to contact aneurysm to final clip placement

Other Outcomes (3)

• Temporary Clip Time

  At time of surgery-Total time (minutes/seconds) of all temporary clip applications to all temporary clip removal

• Microsurgical Time

  At time of surgery-Total time (minutes/seconds) from aneurysm first seen in video to final clip placement

• Wasted Number of Aneurysm Clips

  At time of surgery-Time (minutes/seconds) from first aneurysm clip attempt to final clip placement

Study Arms (2)

Active SRP cases

ACTIVE COMPARATOR

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

Control cases

PLACEBO COMPARATOR

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

Interventions

Active SRP cases OTHER

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.

Also known as: Trade name: Surgical Rehearsal Platform, Regulation Number: 21 CFR 892.2040, Regulation Name: Picture Archiving and Commuications System, Regulatory Class: II, Product Code: LLZ

Active SRP cases

Control cases OTHER

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.

Control cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Links

• Surgical Theater Platform home page

MeSH Terms

Interventions

Regulatory Factor X1

Intervention Hierarchy (Ancestors)

Regulatory Factor X Transcription Factors; Winged-Helix Transcription Factors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors

Results Point of Contact

• Title: Valerie Cwiklinski Clinical Research Nurse
• Organization: University Hospitals Cleveland Medical Center

valerie.cwiklinski1@uhhospitals.org

216-983-5144

Study Officials

• Nicholas C Bambakidis, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cerebrovascular and Skull Based Surgery

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 28, 2014
• Study Start: February 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 5, 2017
• Results First Posted: May 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)