Lumbar SpondylolisthesisPhase 4NCT06255366
Analysis of the Clinical Efficacy of Intravenous Application of Hemostatic Drugs in Improving the Clarity of Vision Under Endoscope, Perioperative Bleeding Volume and Anti-inflammatory Effect of Spinal Endoscopic Lumbar Fusion
A Phase 4 study testing Caroxime sodium sulfonate, Desmopressin and 0.9% Sodium Chloride Injection in people with Lumbar Spondylolisthesis and Arthrosis; Spine, run by Chengdu University of Traditional Chinese Medicine.
Trial summary
To study the clinical efficacy of carosodiumsulfonate and desmopressin in improving the clarity of vision under endoscope, perioperative bleeding volume and anti-inflammatory effect in endoscopic lumbar fusion Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Lumbar Spondylolisthesis, Arthrosis; Spine
- What is being tested?
- Caroxime sodium sulfonate, Desmopressin and 0.9% Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2024to 29 Jun 2025
- Phase
- Phase 4
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, aged 35-65 years old, who were diagnosed as single-segment lumbar spondylolisthesis without spondylolysis based on imaging data and underwent endoscopic lumbar interbody fusion.
- In patients with normal platelet count, blood coagulation function.
- No history of major lumbar trauma and previous lumbar surgery.
- No allergy history, contraindications and serious adverse reactions to desmopressin and carosodiumsulfonate.
- American Society of Anesthesiologists (ASA) classification: grade 1-2
- The participants and their family members were informed of the nature of the study, understood the provisions of the study, complied well, and signed informed consent
Who cannot join
- Patients who do not consent to participate in the trial.
- Poorly controlled hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg.
- People with mental illness, or poor compliance of patients.
- Patients with severe liver function impairment and creatinine clearance <20ml/min.
- Patients with coagulopathy or inability to tolerate surgery.
- Patients with other lumbar spine diseases or pulmonary tuberculosis.
Show all 12Show fewer
- ASA anesthesia level 3 or higher.
- Patients with a long history of smoking, alcohol abuse, or contraceptive drug abuse.
- Patients with serious heart disease, diabetes.
- Imaging tip is merged with other lumbar disease or accompanied by lumbar spondylolysis patients.
- Pregnant women.
- Patients with a history of major lumbar trauma or lumbar surgery.
About this study
To study the clinical efficacy of carosodiumsulfonate and desmopressin in improving the clarity of vision under endoscope, perioperative bleeding volume and anti-inflammatory effect in endoscopic lumbar fusion
Read the detailed description
A total of 129 patients diagnosed with lumbar spondylolisthesis and undergoing endoscopic lumbar fusion in our hospital from February 2024 to February 2025 were prospectively enrolled in this trial. All subjects who met the inclusion criteria were enrolled in the trial after signing the informed consent form. After completing the relevant information registration, routine preoperative preparation was performed and relevant baseline data were collected. The randomization scheme was completed by specialized statisticians independently and was not affected by the subjective will of the researchers and the subjects. According to the random number table method, all subjects were equally allocated to group A, group B and group C at a ratio of 1:1:1. Participants and investigators were blinded to group assignments until the end of the study and were blinded only if a participant developed a serious complication during treatment. Blood routine, liver function, renal function, electrolytes, coagulation indexes and other hematological tests were routinely performed before operation. The volume of blood drawn was about 15ml. Experimental group (group A) : Intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (caroxime sodium sulfonate 80mg and sodium chloride 0.9g) (Chongqing Dikang) was given 5 minutes before operation. One hour after operation, intravenous infusion of carosene sodium sulfonate injection 100ml (carosene sodium sulfonate 80mg and sodium chloride 0.9g) (Chongqing Dicang) [reference to Weiluojing (Carosene sodium sulfonate sodium chloride injection) 100ml (80mg: 0.9g) Usage and dosage: intravenous infusion of 80mg each time (approval number: Chinese Medicine approval number H20052472)]; Experimental group (group B) : Intravenous infusion of desmopressin injection 15ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml 5 minutes before surgery, intravenous infusion of desmopressin injection 15ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml 1 hour after surgery [according to the instructions of desmopressin injection (Hangu), usage and dosage: 1. Control of bleeding or prevention of bleeding before operation: according to the dose of 0.3ug/kg body weight, diluted to 50-100ml with normal saline, intravenous infusion within 15-30min (approval number: H20064093); In control group (group C), 100ml 0.9% sodium chloride solution was intravenously infused 5 minutes before surgery and again 1 hour after surgery. Intraoperative Gertzbein-Sload (GS) score was used to score the clarity of the intraoperative visual field under the microscope. During the operation, the operation time and the total amount of perfusate were recorded, and the red blood cell count was measured by taking the perfusate from the drainage bottle. The blood routine, erythrocyte sedimentation rate, CRP and IL-6 were rechecked at 3 days, and the amount of blood drawn was about 10ml each time. The total blood loss, intraoperative blood loss and hidden blood loss of the patients were recorded, and the VAS scores at 1 day, 2 days and 3 days after operation were recorded. To evaluate the effect of intravenous administration of carosodiumsulfonate and desmopressin on the clarity of visual field under endoscope, perioperative blood loss and postoperative inflammatory indicators in endoscopic lumbar fusion.
- Conditions
- Lumbar Spondylolisthesis, Arthrosis; Spine
- Being tested
- Caroxime sodium sulfonate, Desmopressin, 0.9% Sodium Chloride Injection
- Keywords
- Lumbar Spondylolisthesis, Carbazochrome, Desmopressin, Endoscope
- Medical subject headings
- Spondylolisthesis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caroxime sodium sulfonateDrug
Five minutes before surgery, intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) (trade name: Weiluojing, 100ml, containing caroxime sodium sulfonate 80mg and sodium chloride 0.9g, Chongqing Dikang Changjiang Pharmaceutical Co., LTD.) was given, and intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) was given again 1 hour after surgery.
DesmopressinDrug
Intravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given 5 minutes before surgery, and intravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given again 1 hour after surgery
0.9% Sodium Chloride InjectionDrug
Intravenous infusion of 0.9% sodium chloride injection 100ml (specification 100ml, containing 0.9g sodium chloride, Sichuan Kelun Pharmaceutical Co., LTD.) was given 5 minutes before surgery, and intravenous infusion of 0.9% sodium chloride injection 100ml was given again 1 hour after surgery
| Study group | Role | What they receive |
|---|---|---|
| Caroxime sodium sulfonate | Experimental | Five minutes before surgery, intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) (trade name: Weiluojing, 100ml, containing caroxime sodium sulfonate 80mg and sodium chloride 0.9g, Chongqing Dikang Changjiang Pharmaceutical Co., LTD.) was given, and intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) was given again 1 hour after surgery. Receives: Drug: Caroxime sodium sulfonate |
| Desmopressin | Experimental | Intravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given 5 minutes before surgery, and intravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given again 1 hour after surgery Receives: Drug: Desmopressin |
| 0.9% Sodium chloride injection | Placebo comparator | Intravenous infusion of 0.9% sodium chloride injection 100ml (specification 100ml, containing 0.9g sodium chloride, Sichuan Kelun Pharmaceutical Co., LTD.) was given 5 minutes before surgery, and intravenous infusion of 0.9% sodium chloride injection 100ml was given again 1 hour after surgery Receives: Drug: 0.9% Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarity under microscope
Grade 1: Vital areas cannot be seen clearly but is sufficient to perform surgery. Means that the visual field quality of the operation is low, but sufficient for simple surgical procedures. Grade 2: Visual field clarity is good enough to perform fast and accurate surgery. It means that the quality of the surgical field is good and the operation can be performed efficiently. Grade 3: Excellent visual acuity, can perform difficult surgery. It means that the surgical field is very clear and can perform difficult operations.
Measured: During the operation
Total Blood Loss（TBL）
Preoperative blood volume was calculated according to the Nadler equation, preoperative blood volume (PBV)=K1× height (m)3+ K2× body weight (kg) + K3(male: K1=0.366 9, K2=0.032 19, K3=0.604 1; Female: K1=0.356 1, K2=0.033 08, K3=0.183 3). The Delphi formula was used to calculate the total blood loss of patients, total blood loss = preoperative blood volume ×2× (preoperative hematocrit - postoperative hematocrit)/(preoperative hematocrit + postoperative hematocrit)
Measured: During the operation
Intraoperative Blood Loss（IBL）
Intraoperative Blood Loss (IBL) : IBL = Amount of fluid collected from the drainage bottle + Weight increase of gauze used during the operation - Amount of lavage fluid used during the operation
Measured: During the operation
Hidden Blood Loss（HBL）
Hidden Blood Loss（HBL） = Total Blood Loss（TBL） -Intraoperative Blood Loss（IBL）
Measured: During the operation
Duration of surgery
Measured: During the operation
Intraoperative perfusion fluid consumption
Measured: During the operation
Red blood cells were counted in the postoperative drainage fluid
Measured: Up to 72 hours after surgery
Intraoperative blood pressure values
Systolic and diastolic blood pressure
Measured: During the operation
Secondary outcomes (4)
Erythrocyte sedimentation Rate（ESR）
Measured: Up to 72 hours after surgery
Visual analogue scale
Pain was evaluated using a visual analogue scale (VAS) where 0 was no pain and 10 was unbearable pain.
Measured: Up to 72 hours after surgery
IL--6
Interleukin- 6
Measured: Up to 72 hours after surgery
C-reactive protein
Measured: Up to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start28 Mar 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion29 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylolisthesisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Yang, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255366
- Sponsor's protocol ID
- 2023KL-138
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Clinical Efficacy of Intravenous Application of Hemostatic Drugs in Improving the Clarity of Vision Under Endoscope, Perioperative Bleeding Volume and Anti-inflammatory Effect of Spinal Endoscopic Lumbar Fusion
- ClinicalTrials.gov ID
- NCT06255366
- Acronym / sponsor ID
- 2023KL-138
- Conditions
- Lumbar Spondylolisthesis, Arthrosis; Spine
- Keywords
- Lumbar Spondylolisthesis, Carbazochrome, Desmopressin, Endoscope
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 28 Mar 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 29 Jun 2025 (estimated)
- First posted
- 13 Feb 2024 (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.
To study the clinical efficacy of carosodiumsulfonate and desmopressin in improving the clarity of vision under endoscope, perioperative bleeding volume and anti-inflammatory effect in endoscopic lumbar fusion
Detailed description
A total of 129 patients diagnosed with lumbar spondylolisthesis and undergoing endoscopic lumbar fusion in our hospital from February 2024 to February 2025 were prospectively enrolled in this trial. All subjects who met the inclusion criteria were enrolled in the trial after signing the informed consent form. After completing the relevant information registration, routine preoperative preparation was performed and relevant baseline data were collected. The randomization scheme was completed by specialized statisticians independently and was not affected by the subjective will of the researchers and the subjects. According to the random number table method, all subjects were equally allocated to group A, group B and group C at a ratio of 1:1:1. Participants and investigators were blinded to group assignments until the end of the study and were blinded only if a participant developed a serious complication during treatment. Blood routine, liver function, renal function, electrolytes, coagulation indexes and other hematological tests were routinely performed before operation. The volume of blood drawn was about 15ml. Experimental group (group A) : Intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (caroxime sodium sulfonate 80mg and sodium chloride 0.9g) (Chongqing Dikang) was given 5 minutes before operation. One hour after operation, intravenous infusion of carosene sodium sulfonate injection 100ml (carosene sodium sulfonate 80mg and sodium chloride 0.9g) (Chongqing Dicang) [reference to Weiluojing (Carosene sodium sulfonate sodium chloride injection) 100ml (80mg: 0.9g) Usage and dosage: intravenous infusion of 80mg each time (approval number: Chinese Medicine approval number H20052472)]; Experimental group (group B) : Intravenous infusion of desmopressin injection 15ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml 5 minutes before surgery, intravenous infusion of desmopressin injection 15ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml 1 hour after surgery [according to the instructions of desmopressin injection (Hangu), usage and dosage: 1. Control of bleeding or prevention of bleeding before operation: according to the dose of 0.3ug/kg body weight, diluted to 50-100ml with normal saline, intravenous infusion within 15-30min (approval number: H20064093); In control group (group C), 100ml 0.9% sodium chloride solution was intravenously infused 5 minutes before surgery and again 1 hour after surgery. Intraoperative Gertzbein-Sload (GS) score was used to score the clarity of the intraoperative visual field under the microscope. During the operation, the operation time and the total amount of perfusate were recorded, and the red blood cell count was measured by taking the perfusate from the drainage bottle. The blood routine, erythrocyte sedimentation rate, CRP and IL-6 were rechecked at 3 days, and the amount of blood drawn was about 10ml each time. The total blood loss, intraoperative blood loss and hidden blood loss of the patients were recorded, and the VAS scores at 1 day, 2 days and 3 days after operation were recorded. To evaluate the effect of intravenous administration of carosodiumsulfonate and desmopressin on the clarity of visual field under endoscope, perioperative blood loss and postoperative inflammatory indicators in endoscopic lumbar fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caroxime sodium sulfonate | Experimental | Drug: Caroxime sodium sulfonateFive minutes before surgery, intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) (trade name: Weiluojing, 100ml, containing caroxime sodium sulfonate 80mg and sodium chloride 0.9g, Chongqing Dikang Changjiang Pharmaceutical Co., LTD.) was given, and intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) was given again 1 hour after surgery. |
| Desmopressin | Experimental | Drug: DesmopressinIntravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given 5 minutes before surgery, and intravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given again 1 hour after surgery |
| 0.9% Sodium chloride injection | Placebo comparator | Drug: 0.9% Sodium Chloride InjectionIntravenous infusion of 0.9% sodium chloride injection 100ml (specification 100ml, containing 0.9g sodium chloride, Sichuan Kelun Pharmaceutical Co., LTD.) was given 5 minutes before surgery, and intravenous infusion of 0.9% sodium chloride injection 100ml was given again 1 hour after surgery |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients, aged 35-65 years old, who were diagnosed as single-segment lumbar spondylolisthesis without spondylolysis based on imaging data and underwent endoscopic lumbar interbody fusion.
- In patients with normal platelet count, blood coagulation function.
- No history of major lumbar trauma and previous lumbar surgery.
- No allergy history, contraindications and serious adverse reactions to desmopressin and carosodiumsulfonate.
- American Society of Anesthesiologists (ASA) classification: grade 1-2
Key exclusion criteria (12 listed)
- Patients who do not consent to participate in the trial.
- Poorly controlled hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg.
- People with mental illness, or poor compliance of patients.
- Patients with severe liver function impairment and creatinine clearance <20ml/min.
- Patients with coagulopathy or inability to tolerate surgery.
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 |
|---|---|---|
| Caroxime sodium sulfonateFive minutes before surgery, intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) (trade name: Weiluojing, 100ml, containing caroxime sodium sulfonate 80mg and sodium chloride 0.9g, Chongqing Dikang Changjiang Pharmaceutical Co., LTD.) was given, and intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) was given again 1 hour after surgery. | Drug | Caroxime sodium sulfonate |
| DesmopressinIntravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given 5 minutes before surgery, and intravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given again 1 hour after surgery | Drug | Desmopressin |
| 0.9% Sodium Chloride InjectionIntravenous infusion of 0.9% sodium chloride injection 100ml (specification 100ml, containing 0.9g sodium chloride, Sichuan Kelun Pharmaceutical Co., LTD.) was given 5 minutes before surgery, and intravenous infusion of 0.9% sodium chloride injection 100ml was given again 1 hour after surgery | Drug | 0.9% Sodium chloride injection |
Primary outcome
Clarity under microscope
Time frame: During the operation
Grade 1: Vital areas cannot be seen clearly but is sufficient to perform surgery. Means that the visual field quality of the operation is low, but sufficient for simple surgical procedures. Grade 2: Visual field clarity is good enough to perform fast and accurate surgery. It means that the quality of the surgical field is good and the operation can be performed efficiently. Grade 3: Excellent visual acuity, can perform difficult surgery. It means that the surgical field is very clear and can perform difficult operations.
Total Blood Loss（TBL）
Time frame: During the operation
Preoperative blood volume was calculated according to the Nadler equation, preoperative blood volume (PBV)=K1× height (m)3+ K2× body weight (kg) + K3(male: K1=0.366 9, K2=0.032 19, K3=0.604 1; Female: K1=0.356 1, K2=0.033 08, K3=0.183 3). The Delphi formula was used to calculate the total blood loss of patients, total blood loss = preoperative blood volume ×2× (preoperative hematocrit - postoperative hematocrit)/(preoperative hematocrit + postoperative hematocrit)
Intraoperative Blood Loss（IBL）
Time frame: During the operation
Intraoperative Blood Loss (IBL) : IBL = Amount of fluid collected from the drainage bottle + Weight increase of gauze used during the operation - Amount of lavage fluid used during the operation
Hidden Blood Loss（HBL）
Time frame: During the operation
Hidden Blood Loss（HBL） = Total Blood Loss（TBL） -Intraoperative Blood Loss（IBL）
Duration of surgery
Time frame: During the operation
Intraoperative perfusion fluid consumption
Time frame: During the operation
Red blood cells were counted in the postoperative drainage fluid
Time frame: Up to 72 hours after surgery
Intraoperative blood pressure values
Time frame: During the operation
Systolic and diastolic blood pressure
4 secondary outcomes
Erythrocyte sedimentation Rate（ESR）
Time frame: Up to 72 hours after surgery
Visual analogue scale
Time frame: Up to 72 hours after surgery
IL--6
Time frame: Up to 72 hours after surgery
C-reactive protein
Time frame: Up to 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caroxime sodium sulfonate, Desmopressin and 0.9% Sodium Chloride Injection in people with Lumbar Spondylolisthesis and Arthrosis; Spine, run by Chengdu University of Traditional Chinese Medicine.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Clarity under microscope (time frame: During the operation). The study lists 8 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 15 Mar 2024.