Vascular DiseasesPROSPECTNCT05620186
PROficiency Based StePwise Endovascular Curricular Training: Multicentric Registry
A study testing PROSPECT in people with Vascular Diseases, run by University Hospital, Ghent at 3 sites in 2 countries.
Trial summary
The goal of this multicentric registry is to gather data from trainees completing PROSPECT: a PROficiency Based StePwise Endovascular Curricular Training to obtain basic cognitive and technical skills. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- PROSPECT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Oct 2017to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Surgical trainee
- Knowledge and technical skill level evaluated
- Demographics questionnaire and general MCQ test completed
- Endovascular simulated exercise completed after familiarization with the simulator
Who cannot join
- N/A
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Recruiting
University Hospital Ghent
Ghent, 9000
Isabelle Van Herzeele, MD, PhD, 093325108 ext. +32, isabelle.vanherzeele@ugent.be
- Recruiting
KU Leuven
Leuven, 3000
Inge Fourneau, MD, PhD, inge.fourneau@kuleuven.be
Denmark1 site, 1 recruiting
- Recruiting
CAMES
Copenhagen, 2100
Jonas Eiberg, MD, Phd, jonas.peter.eiberg@regionh.dk
About this study
Official title: Registry Endovascular Training Curriculum PROSPECT for Surgical Trainees (PROficiency-based StePwise Endovascular Curricular Training Program)
The goal of this multicentric registry is to gather data from trainees completing PROSPECT: a PROficiency Based StePwise Endovascular Curricular Training to obtain basic cognitive and technical skills. The main goals are to identify if:
- Results from a previous randomised controlled trail can be reproduced in real life.
- Evaluate skills retention after program completion.
- Assess real life implementation of the training program.
Read the detailed description
A validated PROSPECT (PROficiency-based StePwise Endovascular Curricular Training) training has been integrated into the training of surgical residents to teach basic cognitive, technical and non-technical endovascular skills. The program uses virtual reality simulation and E-learning. During the four modules of the program, formative feedback is given after each training session. Only after achieving a predetermined benchmark score, trainees can progress to the next module.
Surgical trainees completing PROSPECT showed superior real live endovascular performance compared to the traditionally trained in a single centre randomised controlled trial (RCT). The curriculum was integrated locally, but also introduced in other centers: national and international. Local tutors teach the curriculum to trainees after standardized training on the modalities of PROSPECT by the researchers of the Ghent.
A registry is maintained and coordinated by the Ghent research group in which all educational data regarding this training is collected and processed anonymously.
- Conditions
- Vascular Diseases
- Being tested
- PROSPECT
- Keywords
- simulation based education, endovascular procedures
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSPECTOther
PROficiency Based StePwise Endovascular Curricular Training
| Study group | Role | What they receive |
|---|---|---|
| Original PROSPECT | Other | Original, distributed PROSPECT where trainees learn at their own pace in between, before/after clinical activities Receives: Other: PROSPECT |
| Massed PROSPECT | Other | Massed, bootcamp-style training form of PROSPECT where trainees are exempt from clinical duties Receives: Other: PROSPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive skills
Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)
Measured: comparison before program start and after completion. This means through study completion.
Technical skills
Rating scale assessment and simulator metrics
Measured: comparison before program start and after completion. This means through study completion.
Secondary outcomes (2)
Cognitive skills retention
Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)
Measured: 3, 6 and 12 months after program completion
Technical skills retention
Rating scale assessment and simulator metrics
Measured: 3, 6 and 12 months after program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start17 Oct 2017
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Registry, no comparison
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Van Herzeele, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620186
- Sponsor's protocol ID
- BC-877
- Acronym
- PROSPECT
- Status last verified
- Dec 2024
- First submitted
- 2 Nov 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Endovascular Training Curriculum PROSPECT for Surgical Trainees (PROficiency-based StePwise Endovascular Curricular Training Program)
- ClinicalTrials.gov ID
- NCT05620186
- Acronym / sponsor ID
- PROSPECT / BC-877
- Conditions
- Vascular Diseases
- Keywords
- simulation based education, endovascular procedures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Nov 2022 (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.
The goal of this multicentric registry is to gather data from trainees completing PROSPECT: a PROficiency Based StePwise Endovascular Curricular Training to obtain basic cognitive and technical skills. The main goals are to identify if:
- Results from a previous randomised controlled trail can be reproduced in real life.
- Evaluate skills retention after program completion.
- Assess real life implementation of the training program.
Detailed description
A validated PROSPECT (PROficiency-based StePwise Endovascular Curricular Training) training has been integrated into the training of surgical residents to teach basic cognitive, technical and non-technical endovascular skills. The program uses virtual reality simulation and E-learning. During the four modules of the program, formative feedback is given after each training session. Only after achieving a predetermined benchmark score, trainees can progress to the next module.
Surgical trainees completing PROSPECT showed superior real live endovascular performance compared to the traditionally trained in a single centre randomised controlled trial (RCT). The curriculum was integrated locally, but also introduced in other centers: national and international. Local tutors teach the curriculum to trainees after standardized training on the modalities of PROSPECT by the researchers of the Ghent.
A registry is maintained and coordinated by the Ghent research group in which all educational data regarding this training is collected and processed anonymously.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Registry, no comparison
| Arm | Type | Receives |
|---|---|---|
| Original PROSPECT | Other | Other: PROSPECTOriginal, distributed PROSPECT where trainees learn at their own pace in between, before/after clinical activities |
| Massed PROSPECT | Other | Other: PROSPECTMassed, bootcamp-style training form of PROSPECT where trainees are exempt from clinical duties |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Surgical trainee
- Knowledge and technical skill level evaluated
- Demographics questionnaire and general MCQ test completed
- Endovascular simulated exercise completed after familiarization with the simulator
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| PROSPECTPROficiency Based StePwise Endovascular Curricular Training | Other | Massed PROSPECT, Original PROSPECT |
Primary outcome
Cognitive skills
Time frame: comparison before program start and after completion. This means through study completion.
Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)
Technical skills
Time frame: comparison before program start and after completion. This means through study completion.
Rating scale assessment and simulator metrics
2 secondary outcomes
Cognitive skills retention
Time frame: 3, 6 and 12 months after program completion
Technical skills retention
Time frame: 3, 6 and 12 months after program completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Isabelle Van Herzeele, MD, PhD principal investigator
University Hospital, Ghent
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROSPECT in people with Vascular Diseases, run by University Hospital, Ghent at 3 sites in 2 countries.
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 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Van Herzeele, MD, PhD (09 332 51 08 ext. +32, isabelle.vanherzeele@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive skills (time frame: comparison before program start and after completion. This means through study completion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.