Clinical Impact of Rapid Prototyping 3D Models for Surgical Management
NCT ID: NCT04788082
Last Updated: 2021-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-05-01
2021-06-30
Brief Summary
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Detailed Description
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Preliminary studies demonstrate potential for clinical impact of 3D models on patient care and patient outcomes. 3D models have long been shown to enhance education and communication of anatomy. In 2008 Kim et al reviewed 3D printed models as an emerging technology in management of congenital heart disease, and also suggests that physical models may also help enhance patients and physicians' understanding of congenital heart disease. Our group has also published on the clinical and educational value of these 3D heart models. To date, no systematic trial identifying the value of 3D models on procedural planning has been published.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Standard of care (not involving 3D printing)
No interventions assigned to this group
3D Model
3D printed models (at least one rigid blood volume model and one flexible shell model) will be used for surgical planning.
3D Printed Heart Model
Prior to surgical intervention, the surgeon will be exposed to clinically-indicated images and a patient-specific 3D printed model of the subject's heart anatomy.
Interventions
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3D Printed Heart Model
Prior to surgical intervention, the surgeon will be exposed to clinically-indicated images and a patient-specific 3D printed model of the subject's heart anatomy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. double outlet right ventricle (DORV),
2. transposition of the great arteries with ventricular septal defect and pulmonary stenosis (TGA/VSD/PS),
3. truncus arteriosus with ventricular septal defect (TA/VSD)
4. congenitally corrected transposition of the arteries with pulmonary stenosis (CCTGA/PS).
* Patient who will undergo preoperative cardiac MR or cardiac CT imaging
a. Images will be validated by the IRC prior to inclusion
* Written informed consent (and assent when applicable) and HIPAA authorization obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Exclusion Criteria
1. complete or transitional atrioventricular canal
2. double inlet left ventricle
3. tricuspid atresia
4. mitral atresia
* Defects with valve dysfunction requiring an extensive valvuloplasty
* Patients with a contraindication to MRI scanning will be excluded unless they are referred for a cardiac CT per clinical standard of practice. These contraindications include patients with the following devices:
1. Central nervous system aneurysm clips
2. Implanted neural stimulator
3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
4. Cochlear implant
5. Ocular foreign body (e.g. metal shavings)
6. Implanted Insulin pump
7. Metal shrapnel or bullet.
8. Any contraindications to receiving IV gadolinium contrast, determined clinically
* Subjects where MRI or CT images are acquired more than six months prior to the scheduled surgical date
* Subjects where date of scan to date of surgery is less than 10 calendar days
* Subjects where MRI or CT reconstruction is limited due to poor image acquisition as solely determined by the Image Reconstruction Center.
ALL
No
Sponsors
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Phoenix Children's Hospital
OTHER
Children's Hospital of Philadelphia
OTHER
Children's National Research Institute
OTHER
Responsible Party
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Laura Olivieri
Cardiologist
Principal Investigators
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Laura Olivieri, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Stephen Pophal, MD
Role: PRINCIPAL_INVESTIGATOR
Phoenix Children's Hospital
Yoav Dori, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Cardoen B, Demeulemeester E, Beliën J. Operating room planning and scheduling: A literature review. European Journal of Operational Research 201(3): 921-932, 2010.
Costello JP, Olivieri LJ, Krieger A, Thabit O, Marshall MB, Yoo SJ, Kim PC, Jonas RA, Nath DS. Utilizing Three-Dimensional Printing Technology to Assess the Feasibility of High-Fidelity Synthetic Ventricular Septal Defect Models for Simulation in Medical Education. World J Pediatr Congenit Heart Surg. 2014 Jul;5(3):421-6. doi: 10.1177/2150135114528721.
Costello JP, Olivieri LJ, Su L, Krieger A, Alfares F, Thabit O, Marshall MB, Yoo SJ, Kim PC, Jonas RA, Nath DS. Incorporating three-dimensional printing into a simulation-based congenital heart disease and critical care training curriculum for resident physicians. Congenit Heart Dis. 2015 Mar-Apr;10(2):185-90. doi: 10.1111/chd.12238. Epub 2014 Nov 11.
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Does RJMM, Vermaat TMB, Verver JPS, Bisgaard S, Van Den Heuvel J. Reducing Start Time Delays in Operating Rooms. Journal of Quality Technology 41(1): 95-109, 2009.
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Gelijns AC, Moskowitz AJ, Acker MA, Argenziano M, Geller NL, Puskas JD, Perrault LP, Smith PK, Kron IL, Michler RE, Miller MA, Gardner TJ, Ascheim DD, Ailawadi G, Lackner P, Goldsmith LA, Robichaud S, Miller RA, Rose EA, Ferguson TB Jr, Horvath KA, Moquete EG, Parides MK, Bagiella E, O'Gara PT, Blackstone EH; Cardiothoracic Surgical Trials Network (CTSN). Management practices and major infections after cardiac surgery. J Am Coll Cardiol. 2014 Jul 29;64(4):372-81. doi: 10.1016/j.jacc.2014.04.052.
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Kim MS, Hansgen AR, Wink O, Quaife RA, Carroll JD. Rapid prototyping: a new tool in understanding and treating structural heart disease. Circulation. 2008 May 6;117(18):2388-94. doi: 10.1161/CIRCULATIONAHA.107.740977.
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Kutty S, Graney BA, Khoo NS, Li L, Polak A, Gribben P, Hammel JM, Smallhorn JF, Danford DA. Serial assessment of right ventricular volume and function in surgically palliated hypoplastic left heart syndrome using real-time transthoracic three-dimensional echocardiography. J Am Soc Echocardiogr. 2012 Jun;25(6):682-9. doi: 10.1016/j.echo.2012.02.008. Epub 2012 Mar 14.
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Related Links
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Phoenix Children's Hospital's 3D Print Lab
Children's National Medical Center
Other Identifiers
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15-090
Identifier Type: -
Identifier Source: org_study_id
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