Gastrointestinal EndoscopyNCT05485064
Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research
A study testing fentanyl, eletroacupuncture(transcutaneous electrical acupuncture point stimulation ) and remimazolam in people with Gastrointestinal Endoscopy, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The purpose of this study is mainly about the feasibility and rationality of moderate sedation combined with acupuncture anesthesia in the application of gastroscopy and colonoscopy ,Then we evaluate the effectiveness and advantages of the combination of acupuncture anesthesia and drug anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Endoscopy
- What is being tested?
- fentanyl, eletroacupuncture(transcutaneous electrical acupuncture point stimulation ) and remimazolam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 3 Nov 2022
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients
- Patients with ASA grade I-III
- A sufficient level of education to understand study procedures and can communicate with investigators.
Who cannot join
- Patients with serious systemic diseases such as severe cardiopulmonary disease or hepatic diseases or renal diseases.
- Patients under the age of 18.
- Patients who did not sign the informed consent form.
- Patients who have a history of alcohol abuse or drug abuse.
- People who are allergic to anesthetic related ingredients, such as soybeans, eggs and so on.
- Patients with extreme fear or anxiety about acupuncture.
- Patients with relative contraindications of gastrointestinal endoscopy.
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is mainly about the feasibility and rationality of moderate sedation combined with acupuncture anesthesia in the application of gastroscopy and colonoscopy ,Then we evaluate the effectiveness and advantages of the combination of acupuncture anesthesia and drug anesthesia.
Read the detailed description
With the increase of the proportion of the patients who crave for performing painless gastroscopy and colonoscopy in recent years, it is crucial to seek a more secure and effective method of anesthesia or sedation. At present, the universal anesthetic method on gastroscopy and colonoscopy in China is the general anesthesia without intubation which usually uses propofol and opioid analgesics,Although the satisfaction of patients is high, the incidence of anesthesia-related complications and drug-related adverse reactions is high .The incidence of adverse events during the gastroscopy and colonoscopy is high, and the medical expense of anesthesia is high. At present, more than 2/3 of the patients undergo painless gastroscopy or colonoscopy are middle-aged and elderly patients, so the overdose which prolongs the recovery time、discharge time of patients and reduces the recovery quality of patients is common. The moderate sedation, which fundmentally does not affect hemodynamics、autonomous respiration and protective reflexes, is incomparable to general anesthesia . And acupuncture anesthesia also acts as a safe anesthetic method can provide safer analgesic effect.Theoretically，the combination of both of them is a relatively perfect and safe painless method.
- Conditions
- Gastrointestinal Endoscopy
- Being tested
- fentanyl, eletroacupuncture(transcutaneous electrical acupuncture point stimulation ), placebo needle, remimazolam
- Keywords
- eletroacupuncture, moderate sedation, remimazolam, transcutaneous electrical acupuncture point stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
The investigator 1 use fentanyl to sedate patients coordinate with remimazolam
eletroacupuncture(transcutaneous electrical acupuncture point stimulation )Procedure or surgery
The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam
placebo needleDrug
The investigator 1 use placebo needle to sedate patients coordinate with remimazolam
remimazolamDrug
The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam | Experimental | The investigator 1 combine electroacupuncture(transcutaneous acupoint electrical stimulation ) with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. Receives: Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation ); Drug: remimazolam |
| placebo needle and remimazolam | Experimental | The investigator 1 combine placebo needle with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. Receives: Drug: placebo needle; Drug: remimazolam |
| fentanyl and remimazolam | Experimental | The investigator 1 combine fentanyl with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. Receives: Drug: fentanyl; Drug: remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction with sedation instrument，PSSI
The investigator 2 needs to use VAS scores to evaluate satisfaction about sedation feeling when they accepted gastroscopy and colonoscopy .The score ranges from 0 to10 and need patients evaluate it by themself when the gastroscopy or colonoscopy were finished.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）.
Measured: During gastroscopy and colonoscopy
clinical satisfaction with sedation instrument，CSSI
The investigator 2 needs to use VAS scores to evaluate satisfaction about doctors when they carry out the operation.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）.
Measured: During gastroscopy and colonoscopy
patient's pain score
The investigator 2 needs to use VAS scores to evaluate patients' pain score .The score from 0 （extremely dissatisfied）to 10（extremely satisfied）.
Measured: During gastroscopy and colonoscopy
Secondary outcomes (10)
the extent of cardia exposure
The investigator 2 needs to record the extent of cardia exposure to evaluate these interventions'effect on gastroscopy ，the investigator 2 use the table of the extent of preventriculus exposure（score from 1 to 4，1=the extent of exposure lower than 25%；2=the extent of exposure between 25% and 50%；3=the extent of exposure between 50%and 75%；4=the extent of exposure between 75%and 100%）
Measured: During gastroscopy and colonoscopy
adverse reactions
The investigator 2 needs to record the adverse reactions such as nausea、emesis, salivation, restlessness, and breath holding to analyze efficacy of relate treatment.
Measured: During gastroscopy and colonoscopy
patient's recovery time
The investigator 2 needs to record to evaluate patient's recovery quality about patients
Measured: The end of gastroscopy and colonoscopy
patient's departure time
The investigator 2 needs to record patient's departure time to evaluate recovery quality about patients
Measured: The end of gastroscopy and colonoscopy
time to resume normal operation
The investigator 2 needs to record the time to resume normal operation about patient
Measured: The end of gastroscopy and colonoscopy
operation time about gastrointestinal endoscopy
The investigator 2 needs to record operation time about gastrointestinal endoscopy.
Measured: During gastroscopy and colonoscopy
heart rate
The investigator 2 needs to record heart rate（for example 60 times/min）before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（tachycardia：heart rate is more than 100 times/min；bradycardia：heart rate is less than 60 times/min）
Measured: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
pulse oximetry
The investigator 2 needs to record pulse oximetry (for example 97% )before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（hypoxemia：pulse oximetry is lower than 90%）
Measured: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
systolic pressure 、diastolic pressure
The investigator 2 needs to record systolic pressure 、diastolic pressure(for example 120/75mmHg ) before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（hypertension：systolic pressure ≥140mmHg or diastolic pressure ≥90mmHg；hypotension：systolic pressure ≤90mmHg or diastolic pressure ≤60mmHg）
Measured: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
respiratory rate
The investigator 2 needs to record respiratory rate(for example 15 times/min)before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（tachypnea：respiratory rate is more than 20 times/min；bradypnea：respiratory rate is less than 12 times/min）
Measured: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Aug 2022
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jixiangyu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485064
- Sponsor's protocol ID
- QYFYKYLL 916711920
- Status last verified
- Nov 2022
- First submitted
- 29 Jul 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Eberl S, Monteiro de Olivera N, Bourne D, Streitberger K, Fockens P, Hollmann MW, Preckel B. Effect of electroacupuncture on sedation requirements during colonoscopy: a prospective placebo-controlled randomised trial. Acupunct Med. 2020 Jun;38(3):131-139. doi: 10.1136/acupmed-2017-011459. Epub 2020 Jan 22.
PubMed 31968988Yu B, Hazlewood PJ, Yin X, Li S, Yue H, Xu K, Xu S, Mi Y. Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial. Trials. 2022 Apr 27;23(1):364. doi: 10.1186/s13063-022-06165-4.
PubMed 35477483Cohen LB, Hightower CD, Wood DA, Miller KM, Aisenberg J. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc. 2004 Jun;59(7):795-803. doi: 10.1016/s0016-5107(04)00349-9.
PubMed 15173791Qin Z, Ding Y, Xu C, Kwong JSW, Ji Y, Wu A, Wu J, Liu Z. Acupuncture vs Noninsertive Sham Acupuncture in Aging Patients with Degenerative Lumbar Spinal Stenosis: A Randomized Controlled Trial. Am J Med. 2020 Apr;133(4):500-507.e20. doi: 10.1016/j.amjmed.2019.08.038. Epub 2019 Sep 13.
PubMed 31525334Chen JM, Li DD, Chen YS, Lian B, Wang XP, Guo YH, Xu XL, Huang P, Chen TF, Liu Y, Liu QQ. The effectiveness of electro-acupuncture combined with dyclonine hydrochloride in relieving the side effects of gastroscopy: a controlled trial. Ann Palliat Med. 2021 Mar;10(3):2958-2970. doi: 10.21037/apm-20-831. Epub 2021 Mar 1.
PubMed 33691439Xu JH, Tan HL, Zhang LN, Zhou ZG, Yuan L, Kong LX, Song MQ, Qi LJ, Ji XY. Transcutaneous Electrical Acupoint Stimulation Combined with Moderate Sedation of Remimazolam Tosilate in Gastrointestinal Endoscopy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Pain Ther. 2024 Aug;13(4):919-936. doi: 10.1007/s40122-024-00618-1. Epub 2024 Jun 18.
PubMed 38890239
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research
- ClinicalTrials.gov ID
- NCT05485064
- Acronym / sponsor ID
- QYFYKYLL 916711920
- Conditions
- Gastrointestinal Endoscopy
- Keywords
- eletroacupuncture, moderate sedation, remimazolam, transcutaneous electrical acupuncture point stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 3 Aug 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.
The purpose of this study is mainly about the feasibility and rationality of moderate sedation combined with acupuncture anesthesia in the application of gastroscopy and colonoscopy ,Then we evaluate the effectiveness and advantages of the combination of acupuncture anesthesia and drug anesthesia.
Detailed description
With the increase of the proportion of the patients who crave for performing painless gastroscopy and colonoscopy in recent years, it is crucial to seek a more secure and effective method of anesthesia or sedation. At present, the universal anesthetic method on gastroscopy and colonoscopy in China is the general anesthesia without intubation which usually uses propofol and opioid analgesics,Although the satisfaction of patients is high, the incidence of anesthesia-related complications and drug-related adverse reactions is high .The incidence of adverse events during the gastroscopy and colonoscopy is high, and the medical expense of anesthesia is high. At present, more than 2/3 of the patients undergo painless gastroscopy or colonoscopy are middle-aged and elderly patients, so the overdose which prolongs the recovery time、discharge time of patients and reduces the recovery quality of patients is common. The moderate sedation, which fundmentally does not affect hemodynamics、autonomous respiration and protective reflexes, is incomparable to general anesthesia . And acupuncture anesthesia also acts as a safe anesthetic method can provide safer analgesic effect.Theoretically，the combination of both of them is a relatively perfect and safe painless method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam | Experimental | Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation ), Drug: remimazolamThe investigator 1 combine electroacupuncture(transcutaneous acupoint electrical stimulation ) with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. |
| placebo needle and remimazolam | Experimental | Drug: placebo needle, Drug: remimazolamThe investigator 1 combine placebo needle with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. |
| fentanyl and remimazolam | Experimental | Drug: fentanyl, Drug: remimazolamThe investigator 1 combine fentanyl with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients
- Patients with ASA grade I-III
- A sufficient level of education to understand study procedures and can communicate with investigators.
Key exclusion criteria (8 listed)
- Patients with serious systemic diseases such as severe cardiopulmonary disease or hepatic diseases or renal diseases.
- Patients under the age of 18.
- Patients who did not sign the informed consent form.
- Patients who have a history of alcohol abuse or drug abuse.
- People who are allergic to anesthetic related ingredients, such as soybeans, eggs and so on.
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 |
|---|---|---|
| fentanylThe investigator 1 use fentanyl to sedate patients coordinate with remimazolam | Drug | fentanyl and remimazolam |
| eletroacupuncture(transcutaneous electrical acupuncture point stimulation )The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam | Procedure or surgery | electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam |
| placebo needleThe investigator 1 use placebo needle to sedate patients coordinate with remimazolam | Drug | placebo needle and remimazolam |
| remimazolamThe investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle | Drug | electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam, fentanyl and remimazolam, placebo needle and remimazolam |
Primary outcome
patient satisfaction with sedation instrument，PSSI
Time frame: During gastroscopy and colonoscopy
The investigator 2 needs to use VAS scores to evaluate satisfaction about sedation feeling when they accepted gastroscopy and colonoscopy .The score ranges from 0 to10 and need patients evaluate it by themself when the gastroscopy or colonoscopy were finished.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）.
clinical satisfaction with sedation instrument，CSSI
Time frame: During gastroscopy and colonoscopy
The investigator 2 needs to use VAS scores to evaluate satisfaction about doctors when they carry out the operation.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）.
patient's pain score
Time frame: During gastroscopy and colonoscopy
The investigator 2 needs to use VAS scores to evaluate patients' pain score .The score from 0 （extremely dissatisfied）to 10（extremely satisfied）.
10 secondary outcomes
the extent of cardia exposure
Time frame: During gastroscopy and colonoscopy
adverse reactions
Time frame: During gastroscopy and colonoscopy
patient's recovery time
Time frame: The end of gastroscopy and colonoscopy
patient's departure time
Time frame: The end of gastroscopy and colonoscopy
time to resume normal operation
Time frame: The end of gastroscopy and colonoscopy
operation time about gastrointestinal endoscopy
Time frame: During gastroscopy and colonoscopy
heart rate
Time frame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
pulse oximetry
Time frame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
systolic pressure 、diastolic pressure
Time frame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
respiratory rate
Time frame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
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 4 Nov 2022.
- Background: PubMed 31968988Eberl S, Monteiro de Olivera N, Bourne D, Streitberger K, Fockens P, Hollmann MW, Preckel B. Effect of electroacupuncture on sedation requirements during colonoscopy: a prospective placebo-controlled randomised trial. Acupunct Med. 2020 Jun;38(3):131-139. doi: 10.1136/acupmed-2017-011459. Epub 2020 Jan 22.
- Background: PubMed 35477483Yu B, Hazlewood PJ, Yin X, Li S, Yue H, Xu K, Xu S, Mi Y. Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial. Trials. 2022 Apr 27;23(1):364. doi: 10.1186/s13063-022-06165-4.
- Background: PubMed 15173791Cohen LB, Hightower CD, Wood DA, Miller KM, Aisenberg J. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc. 2004 Jun;59(7):795-803. doi: 10.1016/s0016-5107(04)00349-9.
- Background: PubMed 31525334Qin Z, Ding Y, Xu C, Kwong JSW, Ji Y, Wu A, Wu J, Liu Z. Acupuncture vs Noninsertive Sham Acupuncture in Aging Patients with Degenerative Lumbar Spinal Stenosis: A Randomized Controlled Trial. Am J Med. 2020 Apr;133(4):500-507.e20. doi: 10.1016/j.amjmed.2019.08.038. Epub 2019 Sep 13.
- Results publication: PubMed 33691439Chen JM, Li DD, Chen YS, Lian B, Wang XP, Guo YH, Xu XL, Huang P, Chen TF, Liu Y, Liu QQ. The effectiveness of electro-acupuncture combined with dyclonine hydrochloride in relieving the side effects of gastroscopy: a controlled trial. Ann Palliat Med. 2021 Mar;10(3):2958-2970. doi: 10.21037/apm-20-831. Epub 2021 Mar 1.
- Derived from this study: PubMed 38890239Xu JH, Tan HL, Zhang LN, Zhou ZG, Yuan L, Kong LX, Song MQ, Qi LJ, Ji XY. Transcutaneous Electrical Acupoint Stimulation Combined with Moderate Sedation of Remimazolam Tosilate in Gastrointestinal Endoscopy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Pain Ther. 2024 Aug;13(4):919-936. doi: 10.1007/s40122-024-00618-1. Epub 2024 Jun 18.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl, eletroacupuncture(transcutaneous electrical acupuncture point stimulation ) and remimazolam in people with Gastrointestinal Endoscopy, run by The Affiliated Hospital of Qingdao University 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 4 Nov 2022. 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.
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?
patient satisfaction with sedation instrument，PSSI (time frame: During gastroscopy and colonoscopy). 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 NCT05485064, which also lists 6 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 4 Nov 2022.