CraniosynostosesNCT03812159
Clinical Feasibility Study of Preoperative Surgical Planning
A study testing iCSPlan in people with Craniosynostoses, run by Gary F. Rogers, MD at 1 site in United States.
Trial summary
Most children diagnosed with craniosynostosis undergo a relatively extensive cranial vault remodeling procedure. The decision of performing surgical cranial shape correction for patients with craniosynostosis typically rests on a subjective visual assessment of the severity of the cranial malformation and the main… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Craniosynostoses
- What is being tested?
- iCSPlan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 20 Apr 2024
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients under 18 years of age.
- Diagnosis of craniosynostosis.
- Scheduled for open crania vault reconstruction.
- Patients seen in Children's National Medical Center.
Who cannot join
- Lack of interest in participating and refusal to consent.
- Plan for endoscopic craniectomy of synostosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Clinical Feasibility Study of Preoperative Surgical Planning for Craniosynostosis Procedures
Most children diagnosed with craniosynostosis undergo a relatively extensive cranial vault remodeling procedure. The decision of performing surgical cranial shape correction for patients with craniosynostosis typically rests on a subjective visual assessment of the severity of the cranial malformation and the main goal of this procedure is to reduce the risk of elevated intracranial pressure and to provide a more normal cranial shape and volume. Personalized surgical planning systems to optimize intervention and leverage surgical expertise in the reconstruction of the cranial vault do not exist. Thus, the expertise of the surgeon is paramount for the success of the surgical correction of craniosynostosis. The goal of our project is to evaluate the feasibility and utility of a surgical plan derived from software developed at Children's National, iCSPlan.
Read the detailed description
Presurgical planning will be performed in patients that require an open crania-vault reconstruction for craniosynostosis. The participants will come from the outpatient clinics of neurosurgery and plastic surgery. The treating physician/study team member will explain and give a copy of Institutional review board (IRB) approved study information letter to the participant's legally authorized representative (LAR).
The investigators will acquire a pre-operative CT-scan, per standard of care, to help assess the synostosis severity, within 4 weeks before the procedure. A week before the surgery, a routine preoperative visit will be done where the participant and/or LAR, if agree to participate in the study, will sign the informed consent document(s).
A presurgical plan will be built and will be recorded in a software, iCSPlan. Although this plan will not be integrated in the OR workflow, if needed, it would be visualized on a desktop monitor, which will be available to the surgical team. This tool will not influence any clinical decision making in the study. Instead, it will work as a rely-on tool in the preparation of the surgery, which may or may not be followed by the surgeon.
Demographic information (sex, age), as well as intraoperative information (Anesthesia length, anesthesia medications, length of surgery, blood loss, # of blood units transfused, complications), will be recorded for analysis. These variables are generally recorded during surgery and add no additional operative time.
Following the surgery, the specialists will evaluate the feasibility of the use of the presurgical plan by completing a questionnaire to report their options on (1): Quality of the surgical outcome; (2) the quality of the surgical strategy, and (3) the utility of the surgical planning in the treatment. The questions will be answered on a 5-point Likert scale, ranging from "not useful/strongly dislike" to "very useful/strongly like".
All study team pre-screening materials that contain participants information will be maintained on password protected computers. Only authorized study team members will have access to the pre-screening materials. Any pre-screening protected health information (PHI) that is collected will be destroyed once study enrollment is completed.
- Conditions
- Craniosynostoses
- Being tested
- iCSPlan
- Keywords
- Shape analysis, Computer-assisted surgical plan, Surgical planning, Computational anatomy
- Medical subject headings
- Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCSPlanDevice
The Investigator will acquire a routine pre-operative CT-scan to help assess the synostosis severity. A week before the surgery a routine preoperative visit will be done. If the potential subject agrees to participate in the study, a presurgical plan will be built, and based on the CT scan, it will (1) quantify shape differences between pathological and healthy cranial shapes; (2) compensates for brain and cranial growth during the months between diagnosis, treatment and recovery; and (3) guides bone-cuts and bone-placement for the simplest and optimal surgical procedure.
Finally this plan will be recorded in a software, iCSPlan, which will be reviewed by the surgeon. If it is accepted, it will be available during the surgery as a rely-on tool which may or may not be followed.
| Study group | Role | What they receive |
|---|---|---|
| Presurgical planning | Experimental | Undergo crania-vault reconstruction following the presurgical planning (iCSPlan) Receives: Device: iCSPlan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of a surgical planning software (iCSPlan) for open cranial vault reconstructions assessed by how often will the surgeon use or discard the surgical plan
Preoperative planning for cranial vault reconstruction will be built in patients under 18 years old with craniosynostosis. We will document the number of times the surgical plan is followed by the surgeon.
Measured: a week before surgery
Secondary outcomes (6)
To evaluate the utility of the surgical planning software (iCSPlan) assessed by a 5-point Likert scale questionnaire.
Surgeons will review the iCSPlan. To evaluate the utility of the plan, they will complete a questionnaire ranging from 1-5:
- Not at all useful;
- Slightly useful;
- Moderately useful;
- Very useful;
- Extremely useful.
Measured: A week before surgery
To evaluate the quality of the surgical strategy and the surgical outcome built by the surgical planning software (iCSPlan) surgeons will complete a 5-point Likert scale questionnaire.
After reviewing the iCSPlan, surgeons will evaluate the quality of the surgical strategy and outcome by completing a questionnaire ranging from 1-5.
1: Very poor 2. Poor 3. Fair 4. Good 5. Excellent
Measured: a week before surgery
To evaluate the impact of the surgical planning software (iCSplan) assessed by the difference in the length of surgery if the plan is used.
Intra-operative variables such as time of surgery is a quantitative measure that would represent the effect of the use of the iCSPlan. We will compare this value in patients for whom the surgical plan was used and was not used.
Measured: The day of surgery (One day)
To evaluate the intra-operative impact of using a surgical planning software (iCSPlan) assessed by the amount of blood loss, and thus, the amount of transfusion needed.
One of the major concern during an open cranial vault reconstruction is the amount of blood loss. Measuring this variable and the number of blood units transfused will let us evaluate the impact of the iCSPlan.
Measured: The day of surgery (One day)
To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the complications encountered 30-days after the surgery.
Complications such as infection, bleeding, reintervention, brain injury, cranial bone loss, among others, will be recorded in a period of 30 days after the surgery. We will compare the number of complications encountered in patients for whom the surgical plan was used and was not used.
Measured: 30 days after surgery.
To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the length of stay.
We will compare the length of stay in patients for whom the surgical plan was used and was not used.
Measured: One month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jan 2020
- Primary completion20 Mar 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Why it stopped: Study members relocated after Covid and recruitment stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CraniosynostosesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gary F. Rogers, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Gary F. Rogers, MD, Children's National Research Institute
- Investigators
- Gary Rogers, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812159
- Sponsor's protocol ID
- Pro00011015
- Other IDs
- R42HD081712
- Status last verified
- Feb 2024
- First submitted
- 20 Dec 2018
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Porras AR, Paniagua B, Ensel S, Keating R, Rogers GF, Enquobahrie A, Linguraru MG. Locally Affine Diffeomorphic Surface Registration and Its Application to Surgical Planning of Fronto-Orbital Advancement. IEEE Trans Med Imaging. 2018 Jul;37(7):1690-1700. doi: 10.1109/TMI.2018.2816402.
PubMed 29969419Porras AR, Zukic D, Equobahrie A, Rogers GF, Linguraru MG. Personalized Optimal Planning for the Surgical Correction of Metopic Craniosynostosis. Clin Image Based Proced. 2016;2016:60-67. doi: 10.1007/978-3-319-46472-5_8. Epub 2016 Sep 21.
PubMed 28149960Porras AR, Paniagua B, Enquobahrie A, Ensel S, Shah H, Keating R, Rogers GF, Linguraru MG. Locally affine diffeomorphic surface registration for planning of metopic craniosynostosis surgery. Med Image Comput Comput Assist Interv. 2017 Sep;10434:479-487. doi: 10.1007/978-3-319-66185-8_54. Epub 2017 Sep 4.
PubMed 29527598
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility Study of Preoperative Surgical Planning for Craniosynostosis Procedures
- ClinicalTrials.gov ID
- NCT03812159
- Acronym / sponsor ID
- Pro00011015
- Conditions
- Craniosynostoses
- Keywords
- Shape analysis, Computer-assisted surgical plan, Surgical planning, Computational anatomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study members relocated after Covid and recruitment stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gary F. Rogers, MDUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 23 Jan 2019 (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.
Most children diagnosed with craniosynostosis undergo a relatively extensive cranial vault remodeling procedure. The decision of performing surgical cranial shape correction for patients with craniosynostosis typically rests on a subjective visual assessment of the severity of the cranial malformation and the main goal of this procedure is to reduce the risk of elevated intracranial pressure and to provide a more normal cranial shape and volume. Personalized surgical planning systems to optimize intervention and leverage surgical expertise in the reconstruction of the cranial vault do not exist. Thus, the expertise of the surgeon is paramount for the success of the surgical correction of craniosynostosis. The goal of our project is to evaluate the feasibility and utility of a surgical plan derived from software developed at Children's National, iCSPlan.
Detailed description
Presurgical planning will be performed in patients that require an open crania-vault reconstruction for craniosynostosis. The participants will come from the outpatient clinics of neurosurgery and plastic surgery. The treating physician/study team member will explain and give a copy of Institutional review board (IRB) approved study information letter to the participant's legally authorized representative (LAR).
The investigators will acquire a pre-operative CT-scan, per standard of care, to help assess the synostosis severity, within 4 weeks before the procedure. A week before the surgery, a routine preoperative visit will be done where the participant and/or LAR, if agree to participate in the study, will sign the informed consent document(s).
A presurgical plan will be built and will be recorded in a software, iCSPlan. Although this plan will not be integrated in the OR workflow, if needed, it would be visualized on a desktop monitor, which will be available to the surgical team. This tool will not influence any clinical decision making in the study. Instead, it will work as a rely-on tool in the preparation of the surgery, which may or may not be followed by the surgeon.
Demographic information (sex, age), as well as intraoperative information (Anesthesia length, anesthesia medications, length of surgery, blood loss, # of blood units transfused, complications), will be recorded for analysis. These variables are generally recorded during surgery and add no additional operative time.
Following the surgery, the specialists will evaluate the feasibility of the use of the presurgical plan by completing a questionnaire to report their options on (1): Quality of the surgical outcome; (2) the quality of the surgical strategy, and (3) the utility of the surgical planning in the treatment. The questions will be answered on a 5-point Likert scale, ranging from "not useful/strongly dislike" to "very useful/strongly like".
All study team pre-screening materials that contain participants information will be maintained on password protected computers. Only authorized study team members will have access to the pre-screening materials. Any pre-screening protected health information (PHI) that is collected will be destroyed once study enrollment is completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Presurgical planning | Experimental | Device: iCSPlanUndergo crania-vault reconstruction following the presurgical planning (iCSPlan) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients under 18 years of age.
- Diagnosis of craniosynostosis.
- Scheduled for open crania vault reconstruction.
- Patients seen in Children's National Medical Center.
Key exclusion criteria (2 listed)
- Lack of interest in participating and refusal to consent.
- Plan for endoscopic craniectomy of synostosis.
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 |
|---|---|---|
| iCSPlanThe Investigator will acquire a routine pre-operative CT-scan to help assess the synostosis severity. A week before the surgery a routine preoperative visit will be done. If the potential subject agrees to participate in the study, a presurgical plan will be built, and based on the CT scan, it will (1) quantify shape differences between pathological and healthy cranial shapes; (2) compensates for brain and cranial growth during the months between diagnosis, treatment and recovery; and (3) guides bone-cuts and bone-placement for the simplest and optimal surgical procedure. Finally this plan will be recorded in a software, iCSPlan, which will be reviewed by the surgeon. If it is accepted, it will be available during the surgery as a rely-on tool which may or may not be followed. | Device | Presurgical planning |
Primary outcome
To evaluate the feasibility of a surgical planning software (iCSPlan) for open cranial vault reconstructions assessed by how often will the surgeon use or discard the surgical plan
Time frame: a week before surgery
Preoperative planning for cranial vault reconstruction will be built in patients under 18 years old with craniosynostosis. We will document the number of times the surgical plan is followed by the surgeon.
6 secondary outcomes
To evaluate the utility of the surgical planning software (iCSPlan) assessed by a 5-point Likert scale questionnaire.
Time frame: A week before surgery
To evaluate the quality of the surgical strategy and the surgical outcome built by the surgical planning software (iCSPlan) surgeons will complete a 5-point Likert scale questionnaire.
Time frame: a week before surgery
To evaluate the impact of the surgical planning software (iCSplan) assessed by the difference in the length of surgery if the plan is used.
Time frame: The day of surgery (One day)
To evaluate the intra-operative impact of using a surgical planning software (iCSPlan) assessed by the amount of blood loss, and thus, the amount of transfusion needed.
Time frame: The day of surgery (One day)
To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the complications encountered 30-days after the surgery.
Time frame: 30 days after surgery.
To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the length of stay.
Time frame: One month.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 29969419Porras AR, Paniagua B, Ensel S, Keating R, Rogers GF, Enquobahrie A, Linguraru MG. Locally Affine Diffeomorphic Surface Registration and Its Application to Surgical Planning of Fronto-Orbital Advancement. IEEE Trans Med Imaging. 2018 Jul;37(7):1690-1700. doi: 10.1109/TMI.2018.2816402.
- Background: PubMed 28149960Porras AR, Zukic D, Equobahrie A, Rogers GF, Linguraru MG. Personalized Optimal Planning for the Surgical Correction of Metopic Craniosynostosis. Clin Image Based Proced. 2016;2016:60-67. doi: 10.1007/978-3-319-46472-5_8. Epub 2016 Sep 21.
- Background: PubMed 29527598Porras AR, Paniagua B, Enquobahrie A, Ensel S, Shah H, Keating R, Rogers GF, Linguraru MG. Locally affine diffeomorphic surface registration for planning of metopic craniosynostosis surgery. Med Image Comput Comput Assist Interv. 2017 Sep;10434:479-487. doi: 10.1007/978-3-319-66185-8_54. Epub 2017 Sep 4.
- Individual participant dataSharing planned: No
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Metopic Synostosis
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.
Gary Rogers, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCSPlan in people with Craniosynostoses, run by Gary F. Rogers, MD at 1 site 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 8 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 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the feasibility of a surgical planning software (iCSPlan) for open cranial vault reconstructions assessed by how often will the surgeon use or discard the surgical plan (time frame: a week before surgery). 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 NCT03812159, which also lists 3 linked publications.
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 8 Feb 2024.