Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative TreatmentNCT05228093
A Randomized Controlled Clinical Trial of Surgery Versus Conservative Treatment for Mild and Moderate-grade Nasopharyngeal Necrosis
A study testing Curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flap and Conservative treatment in people with Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative Treatment, run by Sun Yat-sen University at 4 sites in China.
Trial summary
Post radiation nasopharyngeal necrosis is a relatively special radiotherapy sequelae after radiotherapy for nasopharyngeal carcinoma. According to the degree of its development, it can be roughly divided into three stages: mild, moderate and severe stages, corresponding to the pre-nasopharyngeal necrosis stage, the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative Treatment
- What is being tested?
- Curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flap and Conservative treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 4 sitesChina
- Study dates
- 1 Nov 2021to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received radical radiotherapy for the nasopharynx;
- For patients with early-stage and mid-stage nasopharyngeal necrosis diagnosed for the first time by clinical symptoms, imaging examinations and pathology. The lesions are limited to the superficial tissue of the nasopharynx and the deep tissue of each wall of the nasopharynx, regardless of the exposure of internal carotid artery invasion(ICA). For those patients with ICA exposure, vascular pretreatment (vascular embolization or bypass surgery) would be performed and reassess after 2-4 weeks of vascular treatment.
- The patient has signed the informed notice and is willing and able to comply with the study plan visits, treatment plans, laboratory tests and other study procedures.
Who cannot join
- Karnofsky score ≤ 70 points or Zubrod score > 2 points;
- Patients with severe medical complications, insufficiency of important organs (heart, lung, liver, kidney) or neuropsychiatric disorders at the time of diagnosis.
- Patients with pathologically confirmed local recurrence.
- Cases who have received local nasal cavity and nasopharyngeal surgery in the past.
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Other patients who are considered unsuitable for inclusion by the treating physician.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ming-Yuan Chen, MD,PhD, 86-20-8734-2422, chenmy@sysucc.org.cn
- Recruiting
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Wei-Ping Wen, MD, PhD, 86-13802966937, wenwp@mail.sysu.edu.cn
- Recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510700
Jian-Zhong Zhang, MD, 86-15820279737, 525567166@qq.com
- Recruiting
The First Hospital of Nanchang
Nanchang, Jiangxi, 330000
Mingyuan Chen, 13903052650, chenmy@sysucc.org.cn
About this study
Official title: A Randomized Controlled Clinical Trial of Curative-intent Endoscopic Necrectomy Followed by Construction Using the Posterior Pedicle Nasal Septum and Floor Mucoperiosteum Flap Versus the Best Conservative Treatment for Mild and Moderate-grade Nasopharyngeal Necrosis
Post radiation nasopharyngeal necrosis is a relatively special radiotherapy sequelae after radiotherapy for nasopharyngeal carcinoma. According to the degree of its development, it can be roughly divided into three stages: mild, moderate and severe stages, corresponding to the pre-nasopharyngeal necrosis stage, the soft tissue necrosis stage and the bone necrosis stage respectively. In the past, treatment methods were limited, including anti-infection, topical nasopharyngeal drugs, etc., the efficacy was not good, the nasopharyngeal necrosis lesions progressed, and a series of serious complications occurred, such as: intracranial infection secondary to osteonecrosis, massive nasopharyngeal hemorrhage, etc. It seriously endanger the life of the patient. With the continuous development of medical technology, the means of treatment are also constantly updated, such as repeated debridement guided by nasal endoscope, modified nasopharyngeal irrigation and hyperbaric oxygen therapy, the healing rate of nasopharyngeal necrosis has improved, especially the cure rate of patients in the mild and moderate-stages can reach 54.1%-54.8%. However, there are still some patients with poor healing of nasopharyngeal wounds after treatment.
Since 2004, our team has carried out a series of studies such as transnasal endoscopic nasopharyngeal resection combined with posterior pedicle nasal septum and floor mucoperiosteum flap(NSFF), and successfully achieved minimally invasive and en bloc resection of localized recurrent nasopharyngeal carcinoma. This method basically solved the problem of surgical wound healing of recurrent nasopharyngeal carcinoma. On this basis, we further applied it to the treatment of nasopharyngeal necrosis to further improve the cure rate and improve the prognosis. In addition, our retrospective study showed that compared with conservative treatment, curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flap can effectively prolong the overall survival time of patients and significantly improve the symptoms, but it still needs to be further confirmed by prospective clinical trials.
Read more
In addition, some patients (22.2%) had necrosis of the mucosal flap after receiving surgery, which affected the healing of surgical wounds. Besides, the development of nasopharyngeal necrosis is a slow process. If nasopharyngeal necrosis removal combined with pedicled mucosal flap repair is performed prematurely, the area outside the operation area may be necrotic again. Theoretically, each patient only has the nasal septum-nasal septum mucosal flaps on both sides of the nasal septum, which means that each patient only has 2 chances of repairing the nasal septum-nasal floor mucosal flaps. Premature surgical intervention may not only lead to incomplete debridement, but also lose a valuable opportunity for mucosal flap repair.
Therefore, based on the above problems, this study intends to compare the endoscopic nasopharyngeal necrosis debridement combined with pedicled mucosal flap repair versus the best conservative regimen for the treatment of early and mid-stage nasopharyngeal necrosis, to explore the prognosis of patients with nasopharyngeal necrosis. The preferred regimen, if confirmed by this study, is expected to standardize the treatment of nasopharyngeal necrosis after radiotherapy and further promote it, effectively increasing the cure rate of nasopharyngeal necrosis and improving the prognosis of patients.
- Conditions
- Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative Treatment
- Being tested
- Curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flap, Conservative treatment
- Medical subject headings
- Nasopharyngeal Carcinoma, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flapProcedure or surgery
Radical endoscopic necrectomy was performed under general anesthesia using the endoscopic endonasal approach. And the reconstruction of the nasopharyngeal defect use the nasal septum and floor mucoperiosteum flap. Antibiotic therapy based on the result of bacterial cultivation before the surgery was administered for 5-7 days after surgery. Patients are prescribed regional perfusion with recombinant human epidermal growth factor derivative liquid (Watsin Genetech Ltd, Shenzhen, Guangdong, P.R. China) to keep the wound humid, and endoscopic nasal cleanup was performed every 2-4 weeks until the flap was completely epithelialized and the entire defect was relined.
Patients who were assessed as non-healing at 3 months after treatment will underwent salvage surgery.
Conservative treatmentProcedure or surgery
Debridement guided by nasopharyngeal endoscopy and excision of the radiation-induced necrotic tissues were performed every 1 or 2 weeks. Patients are prescribed regional perfusion with recombinant human epidermal growth factor derivative liquid (Watsin Genetech Ltd, Shenzhen, Guangdong, P.R. China) to keep the wound humid. Other conservative treatment included daily nasopharynx rinsing with 2% aquae hydrogeniidioxide (5-10 mL each time) or saline (50-100 mL each time) and antibiotic therapy (metronidazole or ornidazole) guided by the culture results was also performed synchronously. Intravenous nutrition and systematic antibiotic therapy were also performed if indicated and necessary. In addition, patients can receive hyperbaric oxygen therapy when conditions permit.
Patients who were assessed as non-healing at 3 months after treatment will underwent salvage surgery.
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | Experimental | Prior to surgery, a bacterial cultivation for purulent nasopharyngeal secretions and drug sensitivity assays were performed to identify sensitive antibiotics to be used postoperatively. Radical endoscopic necrectomy was performed under general anesthesia using the endoscopic endonasal approach. One side flap, typically the ipsilateral side, was harvested after complete radical endoscopic necrectomy. Receives: Procedure: Curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flap |
| Conservative group | Active comparator | Patients receive debridement treatment of the necrotic tissues guided by endoscope and systematic antibiotic therapy partly under the guidance of nasopharyngeal secretion drug sensitivity test.
Patients could use a common nasopharyngeal irrigation pot to wash the nasopharynx three times a day with warm boiled water or light saltwater (500 ml). If possible, patients could also received direct irrigation with an electronic nasopharyngoscopy operated by a physician.
In addition, patients can receive hyperbaric oxygen therapy when conditions permit. Receives: Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cure rate of nasopharyngeal necrosis at 3 months after enrollment
The cure rate of nasopharyngeal necrosis is defined as the complete re-epithelialization of the nasopharyngeal cavity, upon nasal endoscopic examination, and the mucosa; upon MRI examination.
Measured: 3 months
Secondary outcomes (5)
The Numeric Rating Scales (NRS) of pain
The Numeric Rating Scales (NRS) of pain was used to evaluate headaches level before and within 3 months after treatment. The patients were requested to rate their level of headache on a scale from 0 to 10, with 0 being none and 10 being unbearable.
Measured: 3 months
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall
The quality of life was assessed per Quality of Life Questionnaire C30 (QLQ-C30).
Measured: up to 1 year
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
The quality of life was assessed per Quality of Life Questionnaire Head and Neck Cancer-Specific Module (H\&N35).
Measured: up to 1 year
The cure rate of nasopharyngeal necrosis at 6 months after enrollment
Patients who was assessed as non-healing at 3 months after enrollment would receive salvage surgery. The cure rate of nasopharyngeal necrosis is reassessed at 3 months after salvage surgery.
Measured: 6 months
Overall survival
The time from the date of randomization to the date of death due to any cause in an Intent-to-Treat analysis set.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Nov 2021
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative TreatmentStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Mingyuan Chen, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228093
- Sponsor's protocol ID
- NSFF-PRNN-2021
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Curative-intent Endoscopic Necrectomy Followed by Construction Using the Posterior Pedicle Nasal Septum and Floor Mucoperiosteum Flap Versus the Best Conservative Treatment for Mild and Moderate-grade Nasopharyngeal Necrosis
- ClinicalTrials.gov ID
- NCT05228093
- Acronym / sponsor ID
- NSFF-PRNN-2021
- Conditions
- Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 8 Feb 2022 (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.
Post radiation nasopharyngeal necrosis is a relatively special radiotherapy sequelae after radiotherapy for nasopharyngeal carcinoma. According to the degree of its development, it can be roughly divided into three stages: mild, moderate and severe stages, corresponding to the pre-nasopharyngeal necrosis stage, the soft tissue necrosis stage and the bone necrosis stage respectively. In the past, treatment methods were limited, including anti-infection, topical nasopharyngeal drugs, etc., the efficacy was not good, the nasopharyngeal necrosis lesions progressed, and a series of serious complications occurred, such as: intracranial infection secondary to osteonecrosis, massive nasopharyngeal hemorrhage, etc. It seriously endanger the life of the patient. With the continuous development of medical technology, the means of treatment are also constantly updated, such as repeated debridement guided by nasal endoscope, modified nasopharyngeal irrigation and hyperbaric oxygen therapy, the healing rate of nasopharyngeal necrosis has improved, especially the cure rate of patients in the mild and moderate-stages can reach 54.1%-54.8%. However, there are still some patients with poor healing of nasopharyngeal wounds after treatment.
Since 2004, our team has carried out a series of studies such as transnasal endoscopic nasopharyngeal resection combined with posterior pedicle nasal septum and floor mucoperiosteum flap(NSFF), and successfully achieved minimally invasive and en bloc resection of localized recurrent nasopharyngeal carcinoma. This method basically solved the problem of surgical wound healing of recurrent nasopharyngeal carcinoma. On this basis, we further applied it to the treatment of nasopharyngeal necrosis to further improve the cure rate and improve the prognosis. In addition, our retrospective study showed that compared with conservative treatment, curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flap can effectively prolong the overall survival time of patients and significantly improve the symptoms, but it still needs to be further confirmed by prospective clinical trials.
In addition, some patients (22.2%) had necrosis of the mucosal flap after receiving surgery, which affected the healing of surgical wounds. Besides, the development of nasopharyngeal necrosis is a slow process. If nasopharyngeal necrosis removal combined with pedicled mucosal flap repair is performed prematurely, the area outside the operation area may be necrotic again. Theoretically, each patient only has the nasal septum-nasal septum mucosal flaps on both sides of the nasal septum, which means that each patient only has 2 chances of repairing the nasal septum-nasal floor mucosal flaps. Premature surgical intervention may not only lead to incomplete debridement, but also lose a valuable opportunity for mucosal flap repair.
Therefore, based on the above problems, this study intends to compare the endoscopic nasopharyngeal necrosis debridement combined with pedicled mucosal flap repair versus the best conservative regimen for the treatment of early and mid-stage nasopharyngeal necrosis, to explore the prognosis of patients with nasopharyngeal necrosis. The preferred regimen, if confirmed by this study, is expected to standardize the treatment of nasopharyngeal necrosis after radiotherapy and further promote it, effectively increasing the cure rate of nasopharyngeal necrosis and improving the prognosis of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery group | Experimental | Procedure: Curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flapPrior to surgery, a bacterial cultivation for purulent nasopharyngeal secretions and drug sensitivity assays were performed to identify sensitive antibiotics to be used postoperatively. Radical endoscopic necrectomy was performed under general anesthesia using the endoscopic endonasal approach. One side flap, typically the ipsilateral side, was harvested after complete radical endoscopic necrectomy. |
| Conservative group | Active comparator | Procedure: Conservative treatmentPatients receive debridement treatment of the necrotic tissues guided by endoscope and systematic antibiotic therapy partly under the guidance of nasopharyngeal secretion drug sensitivity test. Patients could use a common nasopharyngeal irrigation pot to wash the nasopharynx three times a day with warm boiled water or light saltwater (500 ml). If possible, patients could also received direct irrigation with an electronic nasopharyngoscopy operated by a physician. In addition, patients can receive hyperbaric oxygen therapy when conditions permit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Received radical radiotherapy for the nasopharynx;
- For patients with early-stage and mid-stage nasopharyngeal necrosis diagnosed for the first time by clinical symptoms, imaging examinations and pathology. The lesions are limited to the superficial tissue of the nasopharynx and the deep tissue of each wall of the nasopharynx, regardless of the exposure of internal carotid artery invasion(ICA). For those patients with ICA exposure, vascular pretreatment (vascular embolization or bypass surgery) would be performed and reassess after 2-4 weeks of vascular treatment.
- The patient has signed the informed notice and is willing and able to comply with the study plan visits, treatment plans, laboratory tests and other study procedures.
Key exclusion criteria (6 listed)
- Karnofsky score ≤ 70 points or Zubrod score > 2 points;
- Patients with severe medical complications, insufficiency of important organs (heart, lung, liver, kidney) or neuropsychiatric disorders at the time of diagnosis.
- Patients with pathologically confirmed local recurrence.
- Cases who have received local nasal cavity and nasopharyngeal surgery in the past.
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
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 |
|---|---|---|
| Curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flapRadical endoscopic necrectomy was performed under general anesthesia using the endoscopic endonasal approach. And the reconstruction of the nasopharyngeal defect use the nasal septum and floor mucoperiosteum flap. Antibiotic therapy based on the result of bacterial cultivation before the surgery was administered for 5-7 days after surgery. Patients are prescribed regional perfusion with recombinant human epidermal growth factor derivative liquid (Watsin Genetech Ltd, Shenzhen, Guangdong, P.R. China) to keep the wound humid, and endoscopic nasal cleanup was performed every 2-4 weeks until the flap was completely epithelialized and the entire defect was relined. Patients who were assessed as non-healing at 3 months after treatment will underwent salvage surgery. | Procedure or surgery | Surgery group |
| Conservative treatmentDebridement guided by nasopharyngeal endoscopy and excision of the radiation-induced necrotic tissues were performed every 1 or 2 weeks. Patients are prescribed regional perfusion with recombinant human epidermal growth factor derivative liquid (Watsin Genetech Ltd, Shenzhen, Guangdong, P.R. China) to keep the wound humid. Other conservative treatment included daily nasopharynx rinsing with 2% aquae hydrogeniidioxide (5-10 mL each time) or saline (50-100 mL each time) and antibiotic therapy (metronidazole or ornidazole) guided by the culture results was also performed synchronously. Intravenous nutrition and systematic antibiotic therapy were also performed if indicated and necessary. In addition, patients can receive hyperbaric oxygen therapy when conditions permit. Patients who were assessed as non-healing at 3 months after treatment will underwent salvage surgery. | Procedure or surgery | Conservative group |
Primary outcome
The cure rate of nasopharyngeal necrosis at 3 months after enrollment
Time frame: 3 months
The cure rate of nasopharyngeal necrosis is defined as the complete re-epithelialization of the nasopharyngeal cavity, upon nasal endoscopic examination, and the mucosa; upon MRI examination.
5 secondary outcomes
The Numeric Rating Scales (NRS) of pain
Time frame: 3 months
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall
Time frame: up to 1 year
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Time frame: up to 1 year
The cure rate of nasopharyngeal necrosis at 6 months after enrollment
Time frame: 6 months
Overall survival
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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.
Mingyuan Chen, MD principal investigator
Sun Yat-sen University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curative-intent endoscopic necrectomy followed by reconstruction using the posterior pedicle nasal septum and floor mucoperiosteum flap and Conservative treatment in people with Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative Treatment, run by Sun Yat-sen University at 4 sites 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 6 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Contact Mingyuan Chen, MD (+86 13903052650, chenmy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cure rate of nasopharyngeal necrosis at 3 months after enrollment (time frame: 3 months). 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 8 Feb 2022.