CraniotomyLOOP2NCT04859907
Bone Flap Fixation Systems For Craniotomy Procedures
A study testing Clamp-like system and Plates and screws in people with Craniotomy, run by NEOS Surgery at 3 sites in 2 countries.
Trial summary
Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniotomy
- What is being tested?
- Clamp-like system and Plates and screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Mar 2021to 16 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is 18 years or older.
- The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use.
- At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed.
- Life expectancy higher than 6 months.
- The subject is willing to give his/her informed consent and to comply with the required follow-up.
Who cannot join
- The subject presents any of the contraindications of the assigned craniotomy closure system.
- Orbitozygomatic or mastoid craniotomies.
- Posterior fossa (skull base) surgeries.
- Combined used of craniotomy systems (plates and clamps).
- The subject is currently participating in an investigational drug or device study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario la Paz
Madrid, 28046
About this study
Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.
- Conditions
- Craniotomy
- Being tested
- Clamp-like system, Plates and screws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clamp-like systemDevice
Also called Cranial LOOP
Craniotomy closure
Plates and screwsDevice
Craniotomy closure
| Study group | Role | What they receive |
|---|---|---|
| Clamp-like system | Experimental | Not described Receives: Device: Clamp-like system |
| Plates and screws | Active comparator | Not described Receives: Device: Plates and screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone flap alignment score
1-4
Measured: 6 months
Secondary outcomes (6)
Frequency of adverse effects and device deficiencies (device safety)
Frequency and type of Device related Adverse effects (AE and SAE) and device deficiencies
Measured: 6 months
Bone-flap alignment score
1-4
Measured: 0-7 days after surgery (before discharge)
Surgeon usability questionnaire
Likert scale [1-7], where 1 is very difficult and 7 very easy
Measured: 0 days after surgery
Device related artefacts in neuroimaging
frequency
Measured: 6 months
Device-related bulges or visible offsets
frequency
Measured: 6 months
Post-craniotomy headache
Incidence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start19 Mar 2021
- Primary completion19 Nov 2022
- Study completion16 Feb 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 CraniotomyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEOS Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859907
- Sponsor's protocol ID
- NEO-LOO-2020-01
- Acronym
- LOOP2
- Status last verified
- Feb 2023
- First submitted
- 15 Apr 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gomez de la Riva A, Rico M, Vorsic M, Rokavec V, Asencio-Cortes C, Munoz-Hernandez F. Multicenter Randomized Controlled Clinical Trial to Compare the Safety and Performance of Two Bone Flap Fixation Systems. Oper Neurosurg. 2024 Nov 25;29(3):337-344. doi: 10.1227/ons.0000000000001461.
PubMed 39584820
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Flap Fixation Systems For Craniotomy Procedures
- ClinicalTrials.gov ID
- NCT04859907
- Acronym / sponsor ID
- LOOP2 / NEO-LOO-2020-01
- Conditions
- Craniotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NEOS SurgeryIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 26 Apr 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.
Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clamp-like system | Experimental | Device: Clamp-like system |
| Plates and screws | Active comparator | Device: Plates and screws |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is 18 years or older.
- The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use.
- At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed.
- Life expectancy higher than 6 months.
- The subject is willing to give his/her informed consent and to comply with the required follow-up.
Key exclusion criteria (5 listed)
- The subject presents any of the contraindications of the assigned craniotomy closure system.
- Orbitozygomatic or mastoid craniotomies.
- Posterior fossa (skull base) surgeries.
- Combined used of craniotomy systems (plates and clamps).
- The subject is currently participating in an investigational drug or device study.
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 |
|---|---|---|
| Clamp-like systemAlso: Cranial LOOPCraniotomy closure | Device | Clamp-like system |
| Plates and screwsCraniotomy closure | Device | Plates and screws |
Primary outcome
Bone flap alignment score
Time frame: 6 months
1-4
6 secondary outcomes
Frequency of adverse effects and device deficiencies (device safety)
Time frame: 6 months
Bone-flap alignment score
Time frame: 0-7 days after surgery (before discharge)
Surgeon usability questionnaire
Time frame: 0 days after surgery
Device related artefacts in neuroimaging
Time frame: 6 months
Device-related bulges or visible offsets
Time frame: 6 months
Post-craniotomy headache
Time frame: 6 months
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 1 Aug 2023.
- Derived from this study: PubMed 39584820Gomez de la Riva A, Rico M, Vorsic M, Rokavec V, Asencio-Cortes C, Munoz-Hernandez F. Multicenter Randomized Controlled Clinical Trial to Compare the Safety and Performance of Two Bone Flap Fixation Systems. Oper Neurosurg. 2024 Nov 25;29(3):337-344. doi: 10.1227/ons.0000000000001461.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clamp-like system and Plates and screws in people with Craniotomy, run by NEOS Surgery 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 5 inclusion and 5 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 1 Aug 2023. 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 Spain, Slovenia. 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?
Bone flap alignment score (time frame: 6 months). 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 NCT04859907, 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 1 Aug 2023.