Cranial DefectsNCT06782711
Efficacy and Safety of 3D-Printed PEEK Skull Implants in Cranioplasty
A study testing cranioplasty and customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing in people with Cranial Defects, run by CIMET SCIENTIFIC CORPORATION at 1 site in Mexico.
Trial summary
The goal of this clinical trial is to determine the efficacy and safety of customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Defects
- What is being tested?
- cranioplasty and customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2025to Sep 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years old.
- Both sexes.
- Who agree to participate and sign the informed consent form.
- With loss of a bone segment.
- Area of bone segment loss greater than 1 cm.
- Glasgow Coma Scale score equal to or greater than 9.
- Satisfactory preoperative evaluation
Who cannot join
- Presence of local infection at the craniotomy site or any type of systemic infection at the time of medical evaluation and systemic infection at the time of medical evaluation and during surgery.
- Presence of previous surgical instruments in the cranioplasty site.
- Need to use two or more implants for the reconstruction.
- The resulting angle between the tangential lines to the curvature of the implant and the tangent determined to the center of the implant, determined to the center of the implant, is greater than 50º.
- Patients whose cranial morphology presents difficulties for the prosthesis design.
- Presence of postoperative ossifications in the defect area.
Show all 20Show fewer
- History of hypersensitivity to biomaterials.
- Surgery at the same site within the 6 months prior to the study surgery.
- Patients with any diagnosis that affects blood supply and bone quality.
- Patients who have received chemotherapy or radiotherapy in the surgical region that ended within 6 months prior to the planned surgery or are scheduled for the next 12 weeks.
- Diagnosis of malignant cranial tumor.
- History of any status epilepticus.
- Known history of hemophilia or other clinically significant coagulopathy.
- Patients with uncontrolled diabetes according to, ADA criteria:
- o fasting glucose ≥ 200 mg/dL, HbA1C ≥ 8.5% in the last 3 months.
- Patients with a body mass index (BMI) ≥ 35 kg/m
- History of steroid drugs at least 3 months before surgery.
- Women breastfeeding or pregnant.
- Inability to read and understand the participant's information.
- Prior participation in any related investigational drug or device study within 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Centro de Investigación Clínica y Medicina Traslacional (CIMET)
Guadalajara, Jalisco, 44340
About this study
Official title: Efficacy and Safety of Customized Skull Implants Made of Polyetheretheretherketone Using Three-dimensional Printing in Patients Undergoing Cranioplasty
The goal of this clinical trial is to determine the efficacy and safety of customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty. The main question it aims to answer is:
- Are customized skull implants made of polyetheretheretherketone using 3D printing effective and safe in patients undergoing cranioplasty?
Read more
Participants will:
- The patient will be submitted to cranioplasty.
- The patient will answer the neurological scales at each visit.
- Keep a diary of their symptoms and concomitant medications
- The study will be divided into 5 visits to the center, the surgical intervention and 3 telephone calls where patients will be followed up.
Read the detailed description
The aim of this study is to evaluate the efficacy and safety of personalized skull implants made of polyetheretheretherketone (PEEK) using three-dimensional printing in patients undergoing cranioplasty. This is a phase II clinical trial, with a single group of 30 patients who have suffered cranial bone loss. Specific objectives include analyzing the incidence of complications (infections, fractures, implant exposure), assessing functional recovery using recognized scales such as the Glasgow and Barthel scales, and measuring patient and surgeon aesthetic satisfaction over 12 months.
The design includes multiple follow-up visits, from surgery to one year after, where neurological, functional and cosmetic assessments will be performed.
The selection and exclusion criteria ensure the suitability of the participants, while the variables monitored allow a comprehensive analysis of the results, from cognitive functionality to surgical complications. This study seeks to provide scientific evidence to support the implementation of this technology in patients with cranial defects, improving both quality of life and post-surgical aesthetic and functional outcomes.
-Main inclusion criteria: Being older than 18 years, of both sexes. Loss of cranial bone segment greater than 1 cm². Glasgow Coma Scale (GCS) score equal or greater than 9. Satisfactory pre-surgical evaluation. Signed informed consent.
-Main exclusion criteria: Local infection at the craniotomy site or active systemic infection. Presence of previous surgical instruments at the cranioplasty site. Need to use two or more implants for reconstruction. History of coagulopathies, uncontrolled diabetes mellitus or body mass index (BMI) greater than 35.
Pregnant or lactating women.
-Main variables: Efficacy and safety: frequency of complications such as infections, fractures and implant exposure.
Cognitive functionality: Assessed by the Mini-Mental State Examination (MMSE). Functional independence: Measured with the Barthel index. Degree of disability: Assessed with the Modified Rankin Scale (mRS). Cosmetic satisfaction: Patient and surgeon satisfaction. Adverse events: Incidence during the 12 months of follow-up.
- Conditions
- Cranial Defects
- Being tested
- cranioplasty, customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing
- Keywords
- Cranioplasty, Custom implants, Polyetheretheretherketone (PEEK), Three-dimensional (3D) printing, Neurosurgery, Cranial prostheses, Medical devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranioplastyProcedure or surgery
In this pivotal study of a medical device, patients with bone loss undergo a computed tomography scan, which is used to create a three-dimensional model of the lesion. After validation, the model is printed using PEEK material, and subsequently, the skull is repaired through cranial reconstruction (cranioplasty).
customized skull implants made of polyetheretheretherketone (PEEK) using 3D printingDevice
customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty
| Study group | Role | What they receive |
|---|---|---|
| cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing | Experimental | All participants will undergo cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing Receives: Procedure: cranioplasty; Device: customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and causes of cranioplasty revisions
Cranioplasty revision is performed when it is necessary to correct or adjust a previously placed implant, either due to complications adjust a previously placed implant, either due to complications, lack of integration of the implant or changes in the desired form and function.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (10)
Infection at the implant site
Evaluate the frequency of infection at the implant site after cranioplasty.
Measured: From enrollment to 3 months after surgery
Frequency of surgery-associated infections
These are infections that develop as a direct result of a surgical procedure. These infections can affect various parts of the body and are not necessarily limited to the implant site.
Measured: From enrollment to 3 months after surgery
Frequency of implant exposure
It refers to the fact that the implants placed in the cranial region, in reconstructive or reparative surgeries of the skull, are visible or accessible in some way.
Measured: From enrollment to the end of treatment at 12 months
Frequency and type of implant fractures
Refers to the rupture or cracking of devices implanted in the cranial region, used in reconstructive or reparative surgeries of the skull.
Measured: From enrollment to the end of treatment at 12 months
Level of consciousness
Establish the level of consciousness with the Glasgow Coma Scale (GCS).
Measured: From enrollment to 3 months after surgery
Cognitive function
Measure cognitive function with the Mini-Mental State Examination (MMSE).
Measured: From enrollment to the end of treatment at 12 months
Functional independence
Evaluate functional independence with the Barthel Index.
Measured: From enrollment to the end of treatment at 12 months
Level of disability
Evaluate the degree of disability with the modified Rankin Scale (mRS).
Measured: From enrollment to the end of treatment at 12 months
Cosmetic satisfaction
Subjective scale to assess patient and surgeon satisfaction in terms of aesthetic and functional results after cranioplasty surgery.
Measured: From enrollment to the end of treatment at 12 months
Frequency of adverse incidents
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cranial DefectsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CIMET SCIENTIFIC CORPORATION
- Sponsor type
- University, hospital or other
- Collaborators
- Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)
- Responsible party
- Sponsor
- Investigators
- Geannyne Villegas Rivera, MD, PhD, MBA, Study director, Centro de Investigación Clínica y Medicina Traslacional (CIMET)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782711
- Sponsor's protocol ID
- CIMET-2024-01
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share IPD is currently 'Undecided' because further discussions and evaluations are needed regarding the feasibility, ethical considerations, and alignment with institutional policies. Once these factors are thoroughly assessed, a final determination will be made.
Publications
Yang J, Sun T, Yuan Y, Li X, Yu H, Guan J. Evaluation of titanium mesh cranioplasty and polyetheretherketone cranioplasty: protocol for a multicentre, assessor-blinded, randomised controlled trial. BMJ Open. 2019 Dec 3;9(12):e033997. doi: 10.1136/bmjopen-2019-033997.
PubMed 31796495Sharma N, Aghlmandi S, Dalcanale F, Seiler D, Zeilhofer HF, Honigmann P, Thieringer FM. Quantitative Assessment of Point-of-Care 3D-Printed Patient-Specific Polyetheretherketone (PEEK) Cranial Implants. Int J Mol Sci. 2021 Aug 7;22(16):8521. doi: 10.3390/ijms22168521.
PubMed 34445228Mozaffari K, Rana S, Chow A, Mahgerefteh N, Duong C, Sheppard JP, Phillips HW, Jarrahy R, Yang I. Customized polyetheretherketone (PEEK) implants are associated with similar hospital length of stay compared to autologous bone used in cranioplasty procedures. J Neurol Sci. 2022 Mar 15;434:120169. doi: 10.1016/j.jns.2022.120169. Epub 2022 Jan 24.
PubMed 35134672Henry J, Amoo M, Taylor J, O'Brien DP. Complications of Cranioplasty in Relation to Material: Systematic Review, Network Meta-Analysis and Meta-Regression. Neurosurgery. 2021 Aug 16;89(3):383-394. doi: 10.1093/neuros/nyab180.
PubMed 34100535Csamer L, Csernatony Z, Novak L, Kovari VZ, Kovacs AE, Soosne Horvath H, Mano S. Custom-made 3D printing-based cranioplasty using a silicone mould and PMMA. Sci Rep. 2023 Jul 25;13(1):11985. doi: 10.1038/s41598-023-38772-9.
PubMed 37491550Basgul C, Yu T, MacDonald DW, Siskey R, Marcolongo M, Kurtz SM. Structure-Property Relationships for 3D printed PEEK Intervertebral Lumbar Cages Produced using Fused Filament Fabrication. J Mater Res. 2018 Jul 27;33(14):2040-2051. doi: 10.1557/jmr.2018.178. Epub 2018 Jun 18.
PubMed 30555210Alkhaibary A, Alharbi A, Alnefaie N, Oqalaa Almubarak A, Aloraidi A, Khairy S. Cranioplasty: A Comprehensive Review of the History, Materials, Surgical Aspects, and Complications. World Neurosurg. 2020 Jul;139:445-452. doi: 10.1016/j.wneu.2020.04.211. Epub 2020 May 6.
PubMed 32387405
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Customized Skull Implants Made of Polyetheretheretherketone Using Three-dimensional Printing in Patients Undergoing Cranioplasty
- ClinicalTrials.gov ID
- NCT06782711
- Acronym / sponsor ID
- CIMET-2024-01
- Conditions
- Cranial Defects
- Keywords
- Cranioplasty, Custom implants, Polyetheretheretherketone (PEEK), Three-dimensional (3D) printing, Neurosurgery, Cranial prostheses, Medical devices
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CIMET SCIENTIFIC CORPORATIONUniversity, hospital or other
- Collaborators
- Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Jan 2025 (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 clinical trial is to determine the efficacy and safety of customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty. The main question it aims to answer is:
- Are customized skull implants made of polyetheretheretherketone using 3D printing effective and safe in patients undergoing cranioplasty?
Participants will:
- The patient will be submitted to cranioplasty.
- The patient will answer the neurological scales at each visit.
- Keep a diary of their symptoms and concomitant medications
- The study will be divided into 5 visits to the center, the surgical intervention and 3 telephone calls where patients will be followed up.
Detailed description
The aim of this study is to evaluate the efficacy and safety of personalized skull implants made of polyetheretheretherketone (PEEK) using three-dimensional printing in patients undergoing cranioplasty. This is a phase II clinical trial, with a single group of 30 patients who have suffered cranial bone loss. Specific objectives include analyzing the incidence of complications (infections, fractures, implant exposure), assessing functional recovery using recognized scales such as the Glasgow and Barthel scales, and measuring patient and surgeon aesthetic satisfaction over 12 months.
The design includes multiple follow-up visits, from surgery to one year after, where neurological, functional and cosmetic assessments will be performed.
The selection and exclusion criteria ensure the suitability of the participants, while the variables monitored allow a comprehensive analysis of the results, from cognitive functionality to surgical complications. This study seeks to provide scientific evidence to support the implementation of this technology in patients with cranial defects, improving both quality of life and post-surgical aesthetic and functional outcomes.
-Main inclusion criteria: Being older than 18 years, of both sexes. Loss of cranial bone segment greater than 1 cm². Glasgow Coma Scale (GCS) score equal or greater than 9. Satisfactory pre-surgical evaluation. Signed informed consent.
-Main exclusion criteria: Local infection at the craniotomy site or active systemic infection. Presence of previous surgical instruments at the cranioplasty site. Need to use two or more implants for reconstruction. History of coagulopathies, uncontrolled diabetes mellitus or body mass index (BMI) greater than 35.
Pregnant or lactating women.
-Main variables: Efficacy and safety: frequency of complications such as infections, fractures and implant exposure.
Cognitive functionality: Assessed by the Mini-Mental State Examination (MMSE). Functional independence: Measured with the Barthel index. Degree of disability: Assessed with the Modified Rankin Scale (mRS). Cosmetic satisfaction: Patient and surgeon satisfaction. Adverse events: Incidence during the 12 months of follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing | Experimental | Procedure: cranioplasty, Device: customized skull implants made of polyetheretheretherketone (PEEK) using 3D printingAll participants will undergo cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults >18 years old.
- Both sexes.
- Who agree to participate and sign the informed consent form.
- With loss of a bone segment.
- Area of bone segment loss greater than 1 cm.
Key exclusion criteria (20 listed)
- Presence of local infection at the craniotomy site or any type of systemic infection at the time of medical evaluation and systemic infection at the time of medical evaluation and during surgery.
- Presence of previous surgical instruments in the cranioplasty site.
- Need to use two or more implants for the reconstruction.
- The resulting angle between the tangential lines to the curvature of the implant and the tangent determined to the center of the implant, determined to the center of the implant, is greater than 50º.
- Patients whose cranial morphology presents difficulties for the prosthesis design.
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 |
|---|---|---|
| cranioplastyIn this pivotal study of a medical device, patients with bone loss undergo a computed tomography scan, which is used to create a three-dimensional model of the lesion. After validation, the model is printed using PEEK material, and subsequently, the skull is repaired through cranial reconstruction (cranioplasty). | Procedure or surgery | cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing |
| customized skull implants made of polyetheretheretherketone (PEEK) using 3D printingcustomized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty | Device | cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing |
Primary outcome
Frequency and causes of cranioplasty revisions
Time frame: From enrollment to the end of treatment at 12 months
Cranioplasty revision is performed when it is necessary to correct or adjust a previously placed implant, either due to complications adjust a previously placed implant, either due to complications, lack of integration of the implant or changes in the desired form and function.
10 secondary outcomes
Infection at the implant site
Time frame: From enrollment to 3 months after surgery
Frequency of surgery-associated infections
Time frame: From enrollment to 3 months after surgery
Frequency of implant exposure
Time frame: From enrollment to the end of treatment at 12 months
Frequency and type of implant fractures
Time frame: From enrollment to the end of treatment at 12 months
Level of consciousness
Time frame: From enrollment to 3 months after surgery
Cognitive function
Time frame: From enrollment to the end of treatment at 12 months
Functional independence
Time frame: From enrollment to the end of treatment at 12 months
Level of disability
Time frame: From enrollment to the end of treatment at 12 months
Cosmetic satisfaction
Time frame: From enrollment to the end of treatment at 12 months
Frequency of adverse incidents
Time frame: From enrollment to the end of treatment at 12 months
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 20 Jan 2025.
- Background: PubMed 31796495Yang J, Sun T, Yuan Y, Li X, Yu H, Guan J. Evaluation of titanium mesh cranioplasty and polyetheretherketone cranioplasty: protocol for a multicentre, assessor-blinded, randomised controlled trial. BMJ Open. 2019 Dec 3;9(12):e033997. doi: 10.1136/bmjopen-2019-033997.
- Background: PubMed 34445228Sharma N, Aghlmandi S, Dalcanale F, Seiler D, Zeilhofer HF, Honigmann P, Thieringer FM. Quantitative Assessment of Point-of-Care 3D-Printed Patient-Specific Polyetheretherketone (PEEK) Cranial Implants. Int J Mol Sci. 2021 Aug 7;22(16):8521. doi: 10.3390/ijms22168521.
- Background: PubMed 35134672Mozaffari K, Rana S, Chow A, Mahgerefteh N, Duong C, Sheppard JP, Phillips HW, Jarrahy R, Yang I. Customized polyetheretherketone (PEEK) implants are associated with similar hospital length of stay compared to autologous bone used in cranioplasty procedures. J Neurol Sci. 2022 Mar 15;434:120169. doi: 10.1016/j.jns.2022.120169. Epub 2022 Jan 24.
- Background: PubMed 34100535Henry J, Amoo M, Taylor J, O'Brien DP. Complications of Cranioplasty in Relation to Material: Systematic Review, Network Meta-Analysis and Meta-Regression. Neurosurgery. 2021 Aug 16;89(3):383-394. doi: 10.1093/neuros/nyab180.
- Background: PubMed 37491550Csamer L, Csernatony Z, Novak L, Kovari VZ, Kovacs AE, Soosne Horvath H, Mano S. Custom-made 3D printing-based cranioplasty using a silicone mould and PMMA. Sci Rep. 2023 Jul 25;13(1):11985. doi: 10.1038/s41598-023-38772-9.
- Background: PubMed 30555210Basgul C, Yu T, MacDonald DW, Siskey R, Marcolongo M, Kurtz SM. Structure-Property Relationships for 3D printed PEEK Intervertebral Lumbar Cages Produced using Fused Filament Fabrication. J Mater Res. 2018 Jul 27;33(14):2040-2051. doi: 10.1557/jmr.2018.178. Epub 2018 Jun 18.
- Background: PubMed 32387405Alkhaibary A, Alharbi A, Alnefaie N, Oqalaa Almubarak A, Aloraidi A, Khairy S. Cranioplasty: A Comprehensive Review of the History, Materials, Surgical Aspects, and Complications. World Neurosurg. 2020 Jul;139:445-452. doi: 10.1016/j.wneu.2020.04.211. Epub 2020 May 6.
- Individual participant dataSharing planned: Undecided. The decision to share IPD is currently 'Undecided' because further discussions and evaluations are needed regarding the feasibility, ethical considerations, and alignment with institutional policies. Once these factors are thoroughly assessed, a final determination will be made.
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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.
Geannyne Villegas Rivera, MD, PhD, MBA study director
Centro de Investigación Clínica y Medicina Traslacional (CIMET)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cranioplasty and customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing in people with Cranial Defects, run by CIMET SCIENTIFIC CORPORATION at 1 site in Mexico.
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 7 inclusion and 20 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: enrolling by invitation, as of the sponsor's last update on 20 Jan 2025. 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 Mexico. 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?
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?
Frequency and causes of cranioplasty revisions (time frame: From enrollment to the end of treatment at 12 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 NCT06782711, which also lists 7 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 20 Jan 2025.