Disc HerniationPhase 1/2NCT05808140
Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery
A Phase 1/2 study testing Indocyanine Green and Fluorescence imaging in people with Disc Herniation, run by Zhongnan Hospital at 1 site in China.
Trial summary
In endoscopic spinal nerve root decompression surgery, the intraoperative nerve exploration is time-consuming and critical. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Disc Herniation
- What is being tested?
- Indocyanine Green and Fluorescence imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2023to 14 Dec 2025
- Phase
- Phase 1/2
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with lumbar disc herniation based on symptoms and Imaging examination
- Patients undergo endoscopy spinal surgery for nerve root decompression
- Patients have no clear contraindications to surgery, and has the ability to understand and act and has informed consent, and can participate in all study follow-up voluntarily and signe a written informed consent form.
Who cannot join
- The patients have thyroid related diseases, including autonomous nodules
- Patients are allergic to iodine or shellfish
- Patients have ankylosing spondylitis, lumbar instability or bony spinal stenosis
- Patients have diabetes, vascular related diseases, or abnormal liver and kidney function
- Difficulty in tolerating anaesthesia
- Pregnant or lactating women
- Patients are unable to communicate or do not follow directions
- The investigators consider the patient unsuitable to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430062
About this study
Official title: Clinical Application of Indocyanine Green Fluorescence Imaging to Assist Identification of Nerve Roots in Endoscopic Spinal Surgery
In endoscopic spinal nerve root decompression surgery, the intraoperative nerve exploration is time-consuming and critical. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Damage to nerve roots may lead to postoperative sensory retardation and motor weakness, thereby impairing the physical function of patients. A real-time auxiliary intraoperative nerve identification technology is necessary.
In this prospective, open-label, randomized, parallel controlled trial, 40 patients who undergo endoscopic spinal surgery are included. Subjects are randomly divided into control group and low, medium and high Indocyanine green(ICG) preoperative administration experimental group. Standard endoscopic spinal surgery is performed in the control group. Patients in the experimental group received an intravenous injection of ICG before surgery, and a standard endoscopic spinal surgery is performed with the use of a fluoroscopic endoscopic surgical imaging system to assist the surgeon in identifying and protecting the nerve roots.
The main objectives of this experiment are (i) to explore the safety and feasibility of ICG fluorescence imaging to assist in nerve root identification during endoscopic spinal surgery and (ii) the effectiveness of this technique for endoscopic search for nerve roots. The secondary objective is to explore the optimal ICG dosing regimen.
Read the detailed description
With the accelerated pace of the global aging society, the prevalence of degenerative diseases is increasing. At present, spinal degenerative diseases caused by body degeneration have become the most common type. With the continuous deepening of the research on spinal degenerative diseases and the continuous development, update and promotion of minimally invasive surgery technology and instruments, minimally invasive surgery has attracted more and more attention of spine surgeons due to its advantages of rapid recovery, small trauma and fewer complications.
The core of endoscopic spinal surgery is nerve root decompression. The procedure is centered on the nerve roots, which can be damaged with the slightest carelessness. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Most of the injuries include the stimulation and edema of the nerve root during the operation, which may lead to postoperative sensory retardation and motor weakness, which will damage the patient's physical function and reduce overall satisfaction. The intraoperative nerve exploration is time-consuming and critical, and the variability of the patient's nerve anatomy will also add difficulties to the operation. A real-time auxiliary intraoperative nerve identification technology is necessary.
With the progress of optical technology, fluorescent-guided surgery has shown considerable prospects in assisting in identifying nerves. Indocyanine green (ICG) is the only fluorophore approved by the US Food and Drug Administration (FDA) for intraoperative near-infrared imaging. It can emit near-infrared light after being irradiated by excitation light, which has the characteristics of high penetration depth, low spontaneous fluorescence and high sensitivity. At present, ICG near-infrared fluorescence imaging has been applied to tumor detection, lymphangiography and vascular perfusion evaluation. In recent years, more and more researchers have paid attention to the application value of ICG fluorescence imaging in neuroimaging. It has been applied to clinical research of thoracic sympathetic ganglion, facial nerve, phrenic nerve and pelvic nerve.
- Conditions
- Disc Herniation
- Being tested
- Indocyanine Green, Fluorescence imaging
- Keywords
- Disc Herniation, Endoscopy, Indocyanine green, Near-infrared fluorescence imaging, Spinal nerve roots
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG
Preoperatively, a single dose of intravenous indocyanine green is administered
Fluorescence imagingDevice
Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard endoscopic spinal surgery |
| 0.5mg/kg ICG group | Experimental | The patients receive 0.5mg/kg ICG intravenous injection before surgery. The search for lumbar nerve roots is performed with the assistance of fluoroscopic endoscopic imaging equipment. And the procedure follows standard endoscopic spinal surgery procedures. Receives: Drug: Indocyanine Green; Device: Fluorescence imaging |
| 1mg/kg ICG group | Experimental | The patients receive 1mg/kg ICG intravenous injection before surgery. The search for lumbar nerve roots is performed with the assistance of fluoroscopic endoscopic imaging equipment. And the procedure follows standard endoscopic spinal surgery procedures. Receives: Drug: Indocyanine Green; Device: Fluorescence imaging |
| 2mg/kg ICG group | Experimental | The patients receive 2mg/kg ICG intravenous injection before surgery. The search for lumbar nerve roots is performed with the assistance of fluoroscopic endoscopic imaging equipment. And the procedure follows standard endoscopic spinal surgery procedures. Receives: Drug: Indocyanine Green; Device: Fluorescence imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescence imaging rate of nerve roots
Number of the nerve roots with fluorescent imaging in the experimental group/Total nerve roots in the experimental group×100%
Measured: Intraoperative
Fluorescence signal ratio of nerve root to back fluorescence
Nerve root fluorescence intensity/Background fluorescence intensity
Measured: Immediately postoperative
Time taken to find the nerve root endoscopically
Time from opening the ligamentum flavum to finding the nerve root in spinal endoscopic procedures
Measured: Intraoperative
Secondary outcomes (5)
ICG-related adverse reactions
Measured: Immediately after ICG administration to 30 min after administration
Visual analogue pain scale (Visual analogue scale, VAS)
The VAS pain score uses the VAS scale, with end 0 being no pain, graded 1-4 being mild pain, 5-6 being moderate pain, 7-9 being severe pain, and end 10 being unbearable pain. The higher the score, the more severe the pain level.
Measured: 1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery
Oswestry disability index（ODI）
The ODI score is based on the Oswestry Disability Index questionnaire. The lowest score was 0% and the highest score was 100%, with higher scores indicating more severe functional impairment.
Measured: 1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery
Surgical complications
Record any surgical complications that occurred in the patient within 1 week after surgery
Measured: Within 1 week after surgery
Length of surgery
Use a timer to record the length of the surgery (accurate to the minute)
Measured: From the beginning to the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start11 Apr 2023
- Primary completion14 Dec 2025
- Study completion14 Dec 2025
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 Disc HerniationStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanlong Xie, Zhongnan Hospital
- Investigators
- Yuanlong Xie, M.D., Principal investigator, Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808140
- Sponsor's protocol ID
- Yuanlong Xie
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gokaslan ZL, Telfeian AE, Wang MY. Introduction: Endoscopic spine surgery. Neurosurg Focus. 2016 Feb;40(2):E1. doi: 10.3171/2015.11.FOCUS15597. No abstract available.
PubMed 26828878Fourney DR, Dettori JR, Norvell DC, Dekutoski MB. Does minimal access tubular assisted spine surgery increase or decrease complications in spinal decompression or fusion? Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S57-65. doi: 10.1097/BRS.0b013e3181d82bb8.
PubMed 20407352Strakowski JA. Ultrasound-Guided Peripheral Nerve Procedures. Phys Med Rehabil Clin N Am. 2016 Aug;27(3):687-715. doi: 10.1016/j.pmr.2016.04.006. Epub 2016 Jun 6.
PubMed 27468673He K, Zhou J, Yang F, Chi C, Li H, Mao Y, Hui B, Wang K, Tian J, Wang J. Near-infrared Intraoperative Imaging of Thoracic Sympathetic Nerves: From Preclinical Study to Clinical Trial. Theranostics. 2018 Jan 1;8(2):304-313. doi: 10.7150/thno.22369. eCollection 2018.
PubMed 29290809Kanno K, Aiko K, Yanai S, Sawada M, Sakate S, Andou M. Clinical use of indocyanine green during nerve-sparing surgery for deep endometriosis. Fertil Steril. 2021 Jul;116(1):269-271. doi: 10.1016/j.fertnstert.2021.03.014. Epub 2021 Apr 8.
PubMed 33840452Chen SC, Wang MC, Wang WH, Lee CC, Yang TF, Lin CF, Wang JT, Liao CH, Chang CC, Chen MH, Shih YH, Hsu SP. Fluorescence-assisted visualization of facial nerve during mastoidectomy: A novel technique for preventing iatrogenic facial paralysis. Auris Nasus Larynx. 2015 Apr;42(2):113-8. doi: 10.1016/j.anl.2014.08.008. Epub 2014 Sep 6.
PubMed 25199746He K, Li P, Zhang Z, Liu J, Liu P, Gong S, Chi C, Liu P, Chen C, Tian J. Intraoperative near-infrared fluorescence imaging can identify pelvic nerves in patients with cervical cancer in real time during radical hysterectomy. Eur J Nucl Med Mol Imaging. 2022 Jul;49(8):2929-2937. doi: 10.1007/s00259-022-05686-z. Epub 2022 Mar 1.
PubMed 35230489
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Indocyanine Green Fluorescence Imaging to Assist Identification of Nerve Roots in Endoscopic Spinal Surgery
- ClinicalTrials.gov ID
- NCT05808140
- Acronym / sponsor ID
- Yuanlong Xie
- Conditions
- Disc Herniation
- Keywords
- Disc Herniation, Endoscopy, Indocyanine green, Near-infrared fluorescence imaging, Spinal nerve roots
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 14 Dec 2025 (actual)
- Study completion
- 14 Dec 2025 (actual)
- First posted
- 11 Apr 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.
In endoscopic spinal nerve root decompression surgery, the intraoperative nerve exploration is time-consuming and critical. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Damage to nerve roots may lead to postoperative sensory retardation and motor weakness, thereby impairing the physical function of patients. A real-time auxiliary intraoperative nerve identification technology is necessary.
In this prospective, open-label, randomized, parallel controlled trial, 40 patients who undergo endoscopic spinal surgery are included. Subjects are randomly divided into control group and low, medium and high Indocyanine green(ICG) preoperative administration experimental group. Standard endoscopic spinal surgery is performed in the control group. Patients in the experimental group received an intravenous injection of ICG before surgery, and a standard endoscopic spinal surgery is performed with the use of a fluoroscopic endoscopic surgical imaging system to assist the surgeon in identifying and protecting the nerve roots.
The main objectives of this experiment are (i) to explore the safety and feasibility of ICG fluorescence imaging to assist in nerve root identification during endoscopic spinal surgery and (ii) the effectiveness of this technique for endoscopic search for nerve roots. The secondary objective is to explore the optimal ICG dosing regimen.
Detailed description
With the accelerated pace of the global aging society, the prevalence of degenerative diseases is increasing. At present, spinal degenerative diseases caused by body degeneration have become the most common type. With the continuous deepening of the research on spinal degenerative diseases and the continuous development, update and promotion of minimally invasive surgery technology and instruments, minimally invasive surgery has attracted more and more attention of spine surgeons due to its advantages of rapid recovery, small trauma and fewer complications.
The core of endoscopic spinal surgery is nerve root decompression. The procedure is centered on the nerve roots, which can be damaged with the slightest carelessness. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Most of the injuries include the stimulation and edema of the nerve root during the operation, which may lead to postoperative sensory retardation and motor weakness, which will damage the patient's physical function and reduce overall satisfaction. The intraoperative nerve exploration is time-consuming and critical, and the variability of the patient's nerve anatomy will also add difficulties to the operation. A real-time auxiliary intraoperative nerve identification technology is necessary.
With the progress of optical technology, fluorescent-guided surgery has shown considerable prospects in assisting in identifying nerves. Indocyanine green (ICG) is the only fluorophore approved by the US Food and Drug Administration (FDA) for intraoperative near-infrared imaging. It can emit near-infrared light after being irradiated by excitation light, which has the characteristics of high penetration depth, low spontaneous fluorescence and high sensitivity. At present, ICG near-infrared fluorescence imaging has been applied to tumor detection, lymphangiography and vascular perfusion evaluation. In recent years, more and more researchers have paid attention to the application value of ICG fluorescence imaging in neuroimaging. It has been applied to clinical research of thoracic sympathetic ganglion, facial nerve, phrenic nerve and pelvic nerve.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard endoscopic spinal surgery |
| 0.5mg/kg ICG group | Experimental | Drug: Indocyanine Green, Device: Fluorescence imagingThe patients receive 0.5mg/kg ICG intravenous injection before surgery. The search for lumbar nerve roots is performed with the assistance of fluoroscopic endoscopic imaging equipment. And the procedure follows standard endoscopic spinal surgery procedures. |
| 1mg/kg ICG group | Experimental | Drug: Indocyanine Green, Device: Fluorescence imagingThe patients receive 1mg/kg ICG intravenous injection before surgery. The search for lumbar nerve roots is performed with the assistance of fluoroscopic endoscopic imaging equipment. And the procedure follows standard endoscopic spinal surgery procedures. |
| 2mg/kg ICG group | Experimental | Drug: Indocyanine Green, Device: Fluorescence imagingThe patients receive 2mg/kg ICG intravenous injection before surgery. The search for lumbar nerve roots is performed with the assistance of fluoroscopic endoscopic imaging equipment. And the procedure follows standard endoscopic spinal surgery procedures. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with lumbar disc herniation based on symptoms and Imaging examination
- Patients undergo endoscopy spinal surgery for nerve root decompression
- Patients have no clear contraindications to surgery, and has the ability to understand and act and has informed consent, and can participate in all study follow-up voluntarily and signe a written informed consent form.
Key exclusion criteria (8 listed)
- The patients have thyroid related diseases, including autonomous nodules
- Patients are allergic to iodine or shellfish
- Patients have ankylosing spondylitis, lumbar instability or bony spinal stenosis
- Patients have diabetes, vascular related diseases, or abnormal liver and kidney function
- Difficulty in tolerating anaesthesia
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 |
|---|---|---|
| Indocyanine GreenAlso: ICGPreoperatively, a single dose of intravenous indocyanine green is administered | Drug | 0.5mg/kg ICG group, 1mg/kg ICG group, 2mg/kg ICG group |
| Fluorescence imagingUse of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively | Device | 0.5mg/kg ICG group, 1mg/kg ICG group, 2mg/kg ICG group |
Primary outcome
Fluorescence imaging rate of nerve roots
Time frame: Intraoperative
Number of the nerve roots with fluorescent imaging in the experimental group/Total nerve roots in the experimental group×100%
Fluorescence signal ratio of nerve root to back fluorescence
Time frame: Immediately postoperative
Nerve root fluorescence intensity/Background fluorescence intensity
Time taken to find the nerve root endoscopically
Time frame: Intraoperative
Time from opening the ligamentum flavum to finding the nerve root in spinal endoscopic procedures
5 secondary outcomes
ICG-related adverse reactions
Time frame: Immediately after ICG administration to 30 min after administration
Visual analogue pain scale (Visual analogue scale, VAS)
Time frame: 1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery
Oswestry disability index（ODI）
Time frame: 1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery
Surgical complications
Time frame: Within 1 week after surgery
Length of surgery
Time frame: From the beginning to the end of the surgery
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 19 Dec 2025.
- Background: PubMed 26828878Gokaslan ZL, Telfeian AE, Wang MY. Introduction: Endoscopic spine surgery. Neurosurg Focus. 2016 Feb;40(2):E1. doi: 10.3171/2015.11.FOCUS15597. No abstract available.
- Background: PubMed 20407352Fourney DR, Dettori JR, Norvell DC, Dekutoski MB. Does minimal access tubular assisted spine surgery increase or decrease complications in spinal decompression or fusion? Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S57-65. doi: 10.1097/BRS.0b013e3181d82bb8.
- Background: PubMed 27468673Strakowski JA. Ultrasound-Guided Peripheral Nerve Procedures. Phys Med Rehabil Clin N Am. 2016 Aug;27(3):687-715. doi: 10.1016/j.pmr.2016.04.006. Epub 2016 Jun 6.
- Background: PubMed 29290809He K, Zhou J, Yang F, Chi C, Li H, Mao Y, Hui B, Wang K, Tian J, Wang J. Near-infrared Intraoperative Imaging of Thoracic Sympathetic Nerves: From Preclinical Study to Clinical Trial. Theranostics. 2018 Jan 1;8(2):304-313. doi: 10.7150/thno.22369. eCollection 2018.
- Background: PubMed 33840452Kanno K, Aiko K, Yanai S, Sawada M, Sakate S, Andou M. Clinical use of indocyanine green during nerve-sparing surgery for deep endometriosis. Fertil Steril. 2021 Jul;116(1):269-271. doi: 10.1016/j.fertnstert.2021.03.014. Epub 2021 Apr 8.
- Background: PubMed 25199746Chen SC, Wang MC, Wang WH, Lee CC, Yang TF, Lin CF, Wang JT, Liao CH, Chang CC, Chen MH, Shih YH, Hsu SP. Fluorescence-assisted visualization of facial nerve during mastoidectomy: A novel technique for preventing iatrogenic facial paralysis. Auris Nasus Larynx. 2015 Apr;42(2):113-8. doi: 10.1016/j.anl.2014.08.008. Epub 2014 Sep 6.
- Background: PubMed 35230489He K, Li P, Zhang Z, Liu J, Liu P, Gong S, Chi C, Liu P, Chen C, Tian J. Intraoperative near-infrared fluorescence imaging can identify pelvic nerves in patients with cervical cancer in real time during radical hysterectomy. Eur J Nucl Med Mol Imaging. 2022 Jul;49(8):2929-2937. doi: 10.1007/s00259-022-05686-z. Epub 2022 Mar 1.
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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.
Yuanlong Xie, M.D. principal investigator
Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Indocyanine Green and Fluorescence imaging in people with Disc Herniation, run by Zhongnan Hospital at 1 site in China.
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 3 inclusion and 8 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 19 Dec 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 China. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fluorescence imaging rate of nerve roots (time frame: Intraoperative). The study lists 3 primary outcomes in all. 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 NCT05808140, 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 19 Dec 2025.