Fungal SinusitisNCT05955859
Diagnostics of Mycotic Sinusitis in ENT Patients
A study testing Samplings from patient's affected paranasal sinus in people with Fungal Sinusitis, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Mycotic sinusitis is a rare inflammatory disease of the paranasal sinuses. In recent years, its occurrence is increasing. Due to this situation, mycotic sinusitis is gaining importance, even though most cases of mycotic sinusitis are limited on paranasal sinuses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fungal Sinusitis
- What is being tested?
- Samplings from patient's affected paranasal sinus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCzechia
- Study dates
- 2 May 2023to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- patients with unilateral obfuscation of the paranasal sinus and patients with unilateral discharge from the nasal cavity
Who cannot join
- serious illness (decompensation phase) - cardiac, liver, kidney disease, can-cer
- serious psychiatric illnesses
- pregnancy
- high operative risk according to The American Society of Anesthesiologists (ASA) ≥ IV
- disagreement with participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava, Department of Otorhinolaryngology and Head and Neck Surgery
Ostrava, Czech Republic, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Simona Polášková, MD
About this study
Official title: Diagnostics of Mycotic Sinusitis in Patients With Unilateral Obfuscation of the Paranasal Sinus and Patients With Uni-lateral Discharge From the Nasal Cavity
Mycotic sinusitis is a rare inflammatory disease of the paranasal sinuses. In recent years, its occurrence is increasing. Due to this situation, mycotic sinusitis is gaining importance, even though most cases of mycotic sinusitis are limited on paranasal sinuses.
Non-invasive forms of mycotic sinusitis are divided into mycetoma and allergic mycotic sinusitis. Mycetoma (fungus ball) usually affects only one paranasal sinus, most often maxillary sinus. The predisposing factors which participate on development of mycotic sinusitis are not exactly known. Some factors are considered as possible predisposing factors, for example deviation of nasal septum, dental treatment of upper jaw teeth or changes of nasal microbiome.
The diagnosis of fungal sinusitis is problematic. With the increasing number of patients, it is essential to improve the diagnostic process. In present, suspicion of mycotic sinusitis is based on the patient's clinical symptoms and the endoscopic findings in the nasal cavity. Only in some cases nonspecific findings can be observed, such as smelly secretions from the nose, feeling of stuffy nose and pain over the affected sinus. Some patients may be completely asymptomatic, and only in some cases fungal masses can be observed in the nasal cavity. Computed tomography (CT) scans are gaining more and more importance. Typical sign of an affected sinus is obfuscation on CT scan but this sign is not specific for mycotic infection. Central hyperdense foci are also present in some patients, but they are also not specific and can imitate a foreign body. Identifying specific signs on CT scan could help with diagnosing mycotic sinusitis.
Read the detailed description
To identify specific determining signs for the diagnosis of fungal sinusitis, patients will undergo a series of examinations listed below.
- Entrance ear, nose, throat (ENT) examination
- anamnesis (nasal secretion, nasal obstruction, nose injury, dental procedures on the teeth of the upper jaw, immune disorder)
- rhinological questionnaires (SNOT-22, rhinoVAS, NOSE score, olfactory questionnaire)
- ENT examination without endoscope: deviation of the nasal septum or hypertrophy of the nasal conchae, pathological secretion from the nose
- endoscopic examination of the nose: pathological secretion in the nasal cavity or from the orifice of the sinuses, the presence of fungal masses in the nasal cavity, obstruction of the orifice of the sinuses, the edge of the nasal septum
- Computed tomography (CT) examination of the paranasal sinuses
- evaluation of images in the frontal, sagittal and transverse planes
- criteria of the affected cavity - complete/partial obscuration of the paranasal sinuses, hyperdense core, usuration or thickening of the bone of the paranasal sinuses
- anatomical conditions of the nose and paranasal sinuses - the presence of septal deviation, dental pathology, Onodi's cellar, Haller's cellar, lateral recess of the sphenoid sinus
- Functional endonasal endoscopic surgery (FESS)
- method of execution performance of functional endonasal endoscopic surgery - only the affected cavity is being operated, complete cleaning of the affected cavity
- sampling during surgery (4 in total): two samples for histological examination (sample 1 - mycotic material, sample 2 - mucous of the affected paranasal sinus), sample 3 - mycotic material for culture examination of fungi, sample 4 - mycotic material for elemental analysis using electron microscopy .
- postoperative sample analysis
- elemental analysis (sample 4): before analysis - control X-ray examination of the sample, the presence of hyperdense material on the X-ray image, performing electron microscopy, according to the structure of element evaluation.
- histological examination (sample 1 and 2): evaluation of the sample 2 - mucosa of the paranasal sinuses - the presence of fungal invasion into the mucosa, inflammatory cellulization in the mucosa, evaluation of the sample 1 (mycotic material) - the presence of hyphae, inflammatory cellulization, calcification.
- culture examination (sample 3): evaluation of the cultured finding by a microbiologist
- Conditions
- Fungal Sinusitis
- Being tested
- Samplings from patient's affected paranasal sinus
- Keywords
- Sinusitis, Mycosis, Paranasal sinus
- Medical subject headings
- Sinusitis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samplings from patient's affected paranasal sinusProcedure or surgery
Samplings from patient's affected paranasal sinus during endoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patient with clinical suspicion of mycotic sinusitis | Experimental | Patient with clinical suspicion of mycotic sinusitis will undergo an examination as listed in Detailed Description. Receives: Procedure: Samplings from patient's affected paranasal sinus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computer tomography (CT) examination of the paranasal sinuses - images
Evaluation of images in the frontal, sagittal and transverse planes - condition assessment.
Measured: 3 years
Computer tomography (CT) examination of the paranasal sinuses - criteria
Evaluation of criteria of the affected cavity - complete/partial obscuration of the paranasal sinuses, hyperdense core, usuration or thickening of the bone of the paranasal sinuses.
Measured: 3 years
Computer tomography (CT) examination of the paranasal sinuses - anatomical conditions of the nose and paranasal sinuses
Evaluation of anatomical conditions of the nose and paranasal sinuses - the presence of septal deviation, dental pathology, Onodi's cellar, Haller's cellar, lateral recess of the sphenoid sinus.
Measured: 3 years
Entrance ENT examination - anamnesis
Taking anamnesis from patients to summarize any nasal secretion, nasal obstruction, nose injury, dental procedures on the teeth of the upper jaw or immune disorder.
Measured: 3 years
Entrance ENT examination - SNOT-22
Sino-Nasal Outcome Test-22 (SNOT-22) Questionnaire - The patients will complete a list of symptoms and social/emotional consequences of their nasal disorder. The SNOT-22 is a validated scale that measures sinonasal symptoms in patients with sinusitis. The 22 questions are scored on a scale of 0-5 with a maximum total score of 110. Higher scores represent more symptomatic patients.
Measured: 3 years
Entrance ENT examination - rhinoVAS
Rhino Visual Analogue Scale (RhinoVAS) questionnaire will be used to assess postoperative changes in nasal function ranging from 0 (complete nose patency) to 10 cm (complete nose obstruction).
Measured: 3 years
Entrance ENT examination - NOSE score
A simple, five-question, validated Nasal Obstruction Symptom Evaluation (NOSE) instrument that uses a 20-point scale to capture breathing symptoms, with higher scores indicating more severe symptoms than lower scores. A score of 0 means no problems with nasal obstruction and a score of 100 means the worst possible problems with nasal obstruction.
Measured: 3 years
Entrance ENT examination - olfactory questionnaire
Olfactory questionnaire includes a short examination (test of identification and discrimination with perfumed markers) will be performed.
Measured: 3 years
Entrance ENT examination - without endoscope
Observation of deviation of the nasal septum or hypertrophy of the nasal concha, patho-logical secretion from the nose.
Measured: 3 years
Entrance ENT examination - endoscopic examination
Endoscopic examination of the nose in order to find any pathological secretion in the nasal cavity or from the orifice of the sinuses, the presence of fungal masses in the nasal cavity, obstruction of the orifice of the sinuses, the edge of the nasal septum.
Measured: 3 years
Functional endonasal endoscopic surgery (FESS) - sample 1
Mycotic material (as sample 1) for histological examination will be taken from patient´s affected cavity during FESS.
Measured: 3 years
Functional endonasal endoscopic surgery (FESS) - sample 2
Mucous of the affected paranasal sinus (as sample 2) for histological examination will be taken from patient´s affected cavity during FESS.
Measured: 3 years
Functional endonasal endoscopic surgery (FESS) - sample 3
Mycotic material for culture examination of fungi (as sample 3) will be taken from patient´s affected cavity during FESS.
Measured: 3 years
Functional endonasal endoscopic surgery (FESS) - sample 4
Mycotic material for elemental analysis using electron microscopy (as sample 4) will be taken from patient´s affected cavity during FESS.
Measured: 3 years
Postoperative sample analysis - histological examination of sample 1
Evaluation of the sample 1 (mycotic material) will be done to find out the presence of hyphae, inflammatory cellulization, calcification.
Measured: 3 years
Postoperative sample analysis - histological examination of sample 2
Evaluation of the sample 2 (mucosa of the paranasal sinuses) will be done to find out the presence of fungal invasion into the mucosa, inflammatory cellulization in the mucosa.
Measured: 3 years
Postoperative sample analysis - culture examination of sample 3
Evaluation of the cultured finding will be done by a microbiologist.
Measured: 3 years
Postoperative sample analysis - elemental analysis of sample 4
Control X-ray examination of the sample will be taken before analysis to find out the presence of hyperdense material on the X-ray image. Performing electron microscopy, according to the structure of ele-ment evaluation.
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 posted21 Jul 2023
- Study start2 May 2023
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal SinusitisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Polášková, MD, Principal investigator, University Hospital OstravaPetr Matoušek, MD, Ph.D., Study chair, University Hospital OstravaMichaela Masárová, MD, Study chair, University Hospital OstravaPavel Komínek, Prof., MD, Ph.D., Study chair, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955859
- Sponsor's protocol ID
- KORLCHHK-2023-Mycosis
- Other IDs
- 06-RVO-FNOs/2023
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics of Mycotic Sinusitis in Patients With Unilateral Obfuscation of the Paranasal Sinus and Patients With Uni-lateral Discharge From the Nasal Cavity
- ClinicalTrials.gov ID
- NCT05955859
- Acronym / sponsor ID
- KORLCHHK-2023-Mycosis
- Conditions
- Fungal Sinusitis
- Keywords
- Sinusitis, Mycosis, Paranasal sinus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jul 2023 (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.
Mycotic sinusitis is a rare inflammatory disease of the paranasal sinuses. In recent years, its occurrence is increasing. Due to this situation, mycotic sinusitis is gaining importance, even though most cases of mycotic sinusitis are limited on paranasal sinuses.
Non-invasive forms of mycotic sinusitis are divided into mycetoma and allergic mycotic sinusitis. Mycetoma (fungus ball) usually affects only one paranasal sinus, most often maxillary sinus. The predisposing factors which participate on development of mycotic sinusitis are not exactly known. Some factors are considered as possible predisposing factors, for example deviation of nasal septum, dental treatment of upper jaw teeth or changes of nasal microbiome.
The diagnosis of fungal sinusitis is problematic. With the increasing number of patients, it is essential to improve the diagnostic process. In present, suspicion of mycotic sinusitis is based on the patient's clinical symptoms and the endoscopic findings in the nasal cavity. Only in some cases nonspecific findings can be observed, such as smelly secretions from the nose, feeling of stuffy nose and pain over the affected sinus. Some patients may be completely asymptomatic, and only in some cases fungal masses can be observed in the nasal cavity. Computed tomography (CT) scans are gaining more and more importance. Typical sign of an affected sinus is obfuscation on CT scan but this sign is not specific for mycotic infection. Central hyperdense foci are also present in some patients, but they are also not specific and can imitate a foreign body. Identifying specific signs on CT scan could help with diagnosing mycotic sinusitis.
Detailed description
To identify specific determining signs for the diagnosis of fungal sinusitis, patients will undergo a series of examinations listed below.
- Entrance ear, nose, throat (ENT) examination
- anamnesis (nasal secretion, nasal obstruction, nose injury, dental procedures on the teeth of the upper jaw, immune disorder)
- rhinological questionnaires (SNOT-22, rhinoVAS, NOSE score, olfactory questionnaire)
- ENT examination without endoscope: deviation of the nasal septum or hypertrophy of the nasal conchae, pathological secretion from the nose
- endoscopic examination of the nose: pathological secretion in the nasal cavity or from the orifice of the sinuses, the presence of fungal masses in the nasal cavity, obstruction of the orifice of the sinuses, the edge of the nasal septum
- Computed tomography (CT) examination of the paranasal sinuses
- evaluation of images in the frontal, sagittal and transverse planes
- criteria of the affected cavity - complete/partial obscuration of the paranasal sinuses, hyperdense core, usuration or thickening of the bone of the paranasal sinuses
- anatomical conditions of the nose and paranasal sinuses - the presence of septal deviation, dental pathology, Onodi's cellar, Haller's cellar, lateral recess of the sphenoid sinus
- Functional endonasal endoscopic surgery (FESS)
- method of execution performance of functional endonasal endoscopic surgery - only the affected cavity is being operated, complete cleaning of the affected cavity
- sampling during surgery (4 in total): two samples for histological examination (sample 1 - mycotic material, sample 2 - mucous of the affected paranasal sinus), sample 3 - mycotic material for culture examination of fungi, sample 4 - mycotic material for elemental analysis using electron microscopy .
- postoperative sample analysis
- elemental analysis (sample 4): before analysis - control X-ray examination of the sample, the presence of hyperdense material on the X-ray image, performing electron microscopy, according to the structure of element evaluation.
- histological examination (sample 1 and 2): evaluation of the sample 2 - mucosa of the paranasal sinuses - the presence of fungal invasion into the mucosa, inflammatory cellulization in the mucosa, evaluation of the sample 1 (mycotic material) - the presence of hyphae, inflammatory cellulization, calcification.
- culture examination (sample 3): evaluation of the cultured finding by a microbiologist
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with clinical suspicion of mycotic sinusitis | Experimental | Procedure: Samplings from patient's affected paranasal sinusPatient with clinical suspicion of mycotic sinusitis will undergo an examination as listed in Detailed Description. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 years
- patients with unilateral obfuscation of the paranasal sinus and patients with unilateral discharge from the nasal cavity
Key exclusion criteria (5 listed)
- serious illness (decompensation phase) - cardiac, liver, kidney disease, can-cer
- serious psychiatric illnesses
- pregnancy
- high operative risk according to The American Society of Anesthesiologists (ASA) ≥ IV
- disagreement with participation in the 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 |
|---|---|---|
| Samplings from patient's affected paranasal sinusSamplings from patient's affected paranasal sinus during endoscopic surgery. | Procedure or surgery | Patient with clinical suspicion of mycotic sinusitis |
Primary outcome
Computer tomography (CT) examination of the paranasal sinuses - images
Time frame: 3 years
Evaluation of images in the frontal, sagittal and transverse planes - condition assessment.
Computer tomography (CT) examination of the paranasal sinuses - criteria
Time frame: 3 years
Evaluation of criteria of the affected cavity - complete/partial obscuration of the paranasal sinuses, hyperdense core, usuration or thickening of the bone of the paranasal sinuses.
Computer tomography (CT) examination of the paranasal sinuses - anatomical conditions of the nose and paranasal sinuses
Time frame: 3 years
Evaluation of anatomical conditions of the nose and paranasal sinuses - the presence of septal deviation, dental pathology, Onodi's cellar, Haller's cellar, lateral recess of the sphenoid sinus.
Entrance ENT examination - anamnesis
Time frame: 3 years
Taking anamnesis from patients to summarize any nasal secretion, nasal obstruction, nose injury, dental procedures on the teeth of the upper jaw or immune disorder.
Entrance ENT examination - SNOT-22
Time frame: 3 years
Sino-Nasal Outcome Test-22 (SNOT-22) Questionnaire - The patients will complete a list of symptoms and social/emotional consequences of their nasal disorder. The SNOT-22 is a validated scale that measures sinonasal symptoms in patients with sinusitis. The 22 questions are scored on a scale of 0-5 with a maximum total score of 110. Higher scores represent more symptomatic patients.
Entrance ENT examination - rhinoVAS
Time frame: 3 years
Rhino Visual Analogue Scale (RhinoVAS) questionnaire will be used to assess postoperative changes in nasal function ranging from 0 (complete nose patency) to 10 cm (complete nose obstruction).
Entrance ENT examination - NOSE score
Time frame: 3 years
A simple, five-question, validated Nasal Obstruction Symptom Evaluation (NOSE) instrument that uses a 20-point scale to capture breathing symptoms, with higher scores indicating more severe symptoms than lower scores. A score of 0 means no problems with nasal obstruction and a score of 100 means the worst possible problems with nasal obstruction.
Entrance ENT examination - olfactory questionnaire
Time frame: 3 years
Olfactory questionnaire includes a short examination (test of identification and discrimination with perfumed markers) will be performed.
Entrance ENT examination - without endoscope
Time frame: 3 years
Observation of deviation of the nasal septum or hypertrophy of the nasal concha, patho-logical secretion from the nose.
Entrance ENT examination - endoscopic examination
Time frame: 3 years
Endoscopic examination of the nose in order to find any pathological secretion in the nasal cavity or from the orifice of the sinuses, the presence of fungal masses in the nasal cavity, obstruction of the orifice of the sinuses, the edge of the nasal septum.
Functional endonasal endoscopic surgery (FESS) - sample 1
Time frame: 3 years
Mycotic material (as sample 1) for histological examination will be taken from patient´s affected cavity during FESS.
Functional endonasal endoscopic surgery (FESS) - sample 2
Time frame: 3 years
Mucous of the affected paranasal sinus (as sample 2) for histological examination will be taken from patient´s affected cavity during FESS.
Functional endonasal endoscopic surgery (FESS) - sample 3
Time frame: 3 years
Mycotic material for culture examination of fungi (as sample 3) will be taken from patient´s affected cavity during FESS.
Functional endonasal endoscopic surgery (FESS) - sample 4
Time frame: 3 years
Mycotic material for elemental analysis using electron microscopy (as sample 4) will be taken from patient´s affected cavity during FESS.
Postoperative sample analysis - histological examination of sample 1
Time frame: 3 years
Evaluation of the sample 1 (mycotic material) will be done to find out the presence of hyphae, inflammatory cellulization, calcification.
Postoperative sample analysis - histological examination of sample 2
Time frame: 3 years
Evaluation of the sample 2 (mucosa of the paranasal sinuses) will be done to find out the presence of fungal invasion into the mucosa, inflammatory cellulization in the mucosa.
Postoperative sample analysis - culture examination of sample 3
Time frame: 3 years
Evaluation of the cultured finding will be done by a microbiologist.
Postoperative sample analysis - elemental analysis of sample 4
Time frame: 3 years
Control X-ray examination of the sample will be taken before analysis to find out the presence of hyperdense material on the X-ray image. Performing electron microscopy, according to the structure of ele-ment evaluation.
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 27 Jul 2023.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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.
Simona Polášková, MD principal investigator
University Hospital Ostrava
Petr Matoušek, MD, Ph.D. study chair
University Hospital Ostrava
Michaela Masárová, MD study chair
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samplings from patient's affected paranasal sinus in people with Fungal Sinusitis, run by University Hospital Ostrava at 1 site in Czechia.
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 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: looking for participants now, as of the sponsor's last update on 27 Jul 2023. 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 Czechia. 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 Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computer tomography (CT) examination of the paranasal sinuses - images (time frame: 3 years). The study lists 18 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 27 Jul 2023.