Surgical Patients3DNCT05144620
3D Printing for Pre-Surgical Planning
A study testing 3D Mapping in people with Surgical Patients, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
3D printing is emerging as a new diagnostic tool for pre-surgical planning. 3D printed models are extremely advantageous to surgeons in their preoperative planning. Handling these physical replicas engages active spatial perception skills, enabling a more comprehensive understanding of the presented information in an… Read more about this study
- Who is it for?
- Ages 1 month to 65 years
- Conditions the study is for
- Surgical Patients
- What is being tested?
- 3D Mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Dec 2021to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - Patients seen at UCHealth/CHCO and NOC sites between 6/1/2021 - 6/1/2026
- Pregnant women and their fetuses
Who cannot join
- - Patients 65 and older
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Children's Hospital Colorado
Denver, Colorado, 80217-3364
About this study
3D printing is emerging as a new diagnostic tool for pre-surgical planning. 3D printed models are extremely advantageous to surgeons in their preoperative planning. Handling these physical replicas engages active spatial perception skills, enabling a more comprehensive understanding of the presented information in an inherently intuitive manner that cannot be achieved with conventional methods of imaging review that use screen based 2D and volume rendered representations. The investigators are developing a novel technique to create 3D models derived directly from extremely high-resolution medical images that are superior in spatial and contrast resolution to current 3D modelling methods. This produces patient specific models that contain previously unachievable special fidelity and soft tissue differentiation.
Investigators hypothesize that the preoperative use of these new diagnostic quality models will reduce surgical time and improve post-surgical outcomes in the near future. This prospective project will optimize the quality of these 3D models to create highly useful pre-surgical models. Investigators will target those subspecialist areas of the multidisciplinary surgical and imaging team where it is believed these models will have the most impact. The proposed prospective study has two major goals: 1) Investigate the use of uncompressed, ultrahigh resolution CT/MR datasets to produce diagnostic 3D models with identical spatial/contrast resolution to the acquired datasets in the target areas of congenital cardiothoracic surgery, neurosurgical tumor resection and nephrectomy. 2) Compare the accuracy of this innovative method for 3D printing to radiological images and pathological data when available.
Read the detailed description
The tangible outcome of this research will be measured in a comparative study. The investigators will compare the 3D printed models, resulting from the development of this iterative process of generating models from ultra-high resolution medical images and review by all parties, to radiological images and pathological data. The study team will employ non-biased methods to quantify the results of this comparative study. There will be no randomization and all subjects will receive the same treatments and all outcomes are data focused. Models will not be used for patient treatment and will be used only as to aid preparation and will not be used as a therapeutic device. For this reason, the study team will not prospectively consent subjects.
- Conditions
- Surgical Patients
- Being tested
- 3D Mapping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D MappingDiagnostic test
3D model will be made from diagnostic imaging for pre-surgical planning
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Imaging | Experimental | Not described Receives: Diagnostic Test: 3D Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing 3D Models as a new diagnostic tool for pre-surgical training to reduce surgical time
Focus on using pre-operative imaging for producing 3D models for 3 specific presurgical evaluations 1) Adult Clear Cell Renal Mass with a focus on partial nephrectomies. 2) Pediatric Cardiothoracic Surgery 3) Pediatric Neurosurgical primary brain tumor resection involving eloquent areas of the brain (eg speech center, auditory center, visual center, motor cortex, and sensory cortex). 4) Plastic Surgery and Craniomaxillofacial disciplines with a focus on DIEP Flap reconstructions and Alveolar Bone Graft procedures.
Change in surgical time based on using a 3D model per-operatively
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start30 Dec 2021
- Primary completion7 Dec 2022
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical PatientsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Jacobson, Principal investigator, Colorado Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144620
- Sponsor's protocol ID
- 21-3135.cc
- Acronym
- 3D
- Status last verified
- Feb 2024
- First submitted
- 27 Sep 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacobson NM, Carerra E, Treat A, McDonnell M, Mathes D, Kaoutzanis C. Hybrid modeling techniques for 3D printed deep inferior epigastric perforator flap models. 3D Print Med. 2023 Sep 12;9(1):26. doi: 10.1186/s41205-023-00181-z.
PubMed 37700101
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printing for Pre-Surgical Planning
- ClinicalTrials.gov ID
- NCT05144620
- Acronym / sponsor ID
- 3D / 21-3135.cc
- Conditions
- Surgical Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
3D printing is emerging as a new diagnostic tool for pre-surgical planning. 3D printed models are extremely advantageous to surgeons in their preoperative planning. Handling these physical replicas engages active spatial perception skills, enabling a more comprehensive understanding of the presented information in an inherently intuitive manner that cannot be achieved with conventional methods of imaging review that use screen based 2D and volume rendered representations. The investigators are developing a novel technique to create 3D models derived directly from extremely high-resolution medical images that are superior in spatial and contrast resolution to current 3D modelling methods. This produces patient specific models that contain previously unachievable special fidelity and soft tissue differentiation.
Investigators hypothesize that the preoperative use of these new diagnostic quality models will reduce surgical time and improve post-surgical outcomes in the near future. This prospective project will optimize the quality of these 3D models to create highly useful pre-surgical models. Investigators will target those subspecialist areas of the multidisciplinary surgical and imaging team where it is believed these models will have the most impact. The proposed prospective study has two major goals: 1) Investigate the use of uncompressed, ultrahigh resolution CT/MR datasets to produce diagnostic 3D models with identical spatial/contrast resolution to the acquired datasets in the target areas of congenital cardiothoracic surgery, neurosurgical tumor resection and nephrectomy. 2) Compare the accuracy of this innovative method for 3D printing to radiological images and pathological data when available.
Detailed description
The tangible outcome of this research will be measured in a comparative study. The investigators will compare the 3D printed models, resulting from the development of this iterative process of generating models from ultra-high resolution medical images and review by all parties, to radiological images and pathological data. The study team will employ non-biased methods to quantify the results of this comparative study. There will be no randomization and all subjects will receive the same treatments and all outcomes are data focused. Models will not be used for patient treatment and will be used only as to aid preparation and will not be used as a therapeutic device. For this reason, the study team will not prospectively consent subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative Imaging | Experimental | Diagnostic Test: 3D Mapping |
Who may qualify
- Ages
- 1 month to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- - Patients seen at UCHealth/CHCO and NOC sites between 6/1/2021 - 6/1/2026
- Pregnant women and their fetuses
Key exclusion criteria (1 listed)
- - Patients 65 and older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Mapping3D model will be made from diagnostic imaging for pre-surgical planning | Diagnostic test | Preoperative Imaging |
Primary outcome
Comparing 3D Models as a new diagnostic tool for pre-surgical training to reduce surgical time
Time frame: 3 years
Focus on using pre-operative imaging for producing 3D models for 3 specific presurgical evaluations 1) Adult Clear Cell Renal Mass with a focus on partial nephrectomies. 2) Pediatric Cardiothoracic Surgery 3) Pediatric Neurosurgical primary brain tumor resection involving eloquent areas of the brain (eg speech center, auditory center, visual center, motor cortex, and sensory cortex). 4) Plastic Surgery and Craniomaxillofacial disciplines with a focus on DIEP Flap reconstructions and Alveolar Bone Graft procedures. Change in surgical time based on using a 3D model per-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 37700101Jacobson NM, Carerra E, Treat A, McDonnell M, Mathes D, Kaoutzanis C. Hybrid modeling techniques for 3D printed deep inferior epigastric perforator flap models. 3D Print Med. 2023 Sep 12;9(1):26. doi: 10.1186/s41205-023-00181-z.
- Individual participant dataSharing planned: No
Related trials for Surgical Patients
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Jacobson principal investigator
Colorado Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Mapping in people with Surgical Patients, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing 3D Models as a new diagnostic tool for pre-surgical training to reduce surgical time (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.