Cervical DilatationsNCT05955768
Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Disposable Cervical Dilator"
A study testing Disposable cervical dilator stick combined with lidocaine hydrochloride injection and Disposable cervical dilator stick combined with normal saline injection in people with Cervical Dilatations, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
This study is a multicenter, randomized (each group was assigned 1:1), double-blind controlled trial. This study aims to investigate if lidocaine injection into the single-use micro-non-invasive injection cervical dilator (short for disposable cervical dilators) leads to better pain control efficacy compared with… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Dilatations
- What is being tested?
- Disposable cervical dilator stick combined with lidocaine hydrochloride injection and Disposable cervical dilator stick combined with normal saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2023to Aug 2026
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 and <65 years old;
- Voluntary request for removal of intrauterine device under local anesthesia;
- No known allergic reactions or sensitivity to lidocaine, physiological saline and polyvinyl formaldehyde polymer materials in the past;
- Volunteer participation in this study.
Who cannot join
- Dysplasia of uterine cavity structure;
- Known lesions such as uterine fibroids that compress and cause uterine cavity deformation;
- Presence of untreated acute cervicitis or pelvic inflammatory diseases;
- History of cervical surgery;
- Systemic diseases that can affect pain perception;
- Current or past use of illegal drugs or anesthetic and analgesic drugs;
- Unable to understand how to score pain using Visual Analog Scale (short for VAS).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Single-use Micro-non-invasive Injection Cervical Dilator"
This study is a multicenter, randomized (each group was assigned 1:1), double-blind controlled trial.
This study aims to investigate if lidocaine injection into the single-use micro-non-invasive injection cervical dilator (short for disposable cervical dilators) leads to better pain control efficacy compared with normal saline injection in intrauterine device(short for IUD) removal surgery. Furthermore, this study aims to compare cervical dilation degree, safety, and patient satisfaction between groups.
Read more
Research objects Between August 1, 2023, and August 1, 2025, 74 healthy women who voluntarily request the removal of the intrauterine device under local anesthesia in Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine.
The subjects will be dividied into two groups at random.
- Trial group: disposable cervical dilator stick combined with lidocaine hydrochloride injection.
- Control group: disposable cervical dilator stick combined with normal saline injection.
Intervention measures:
The nurse fill the syringe with 5ml of either 2% lidocaine hydrochloride injection or normal saline based on the group allocation specified. The appearance of the two drugs is indistinguishable after loading.
The subject will undergo routine disinfection and receive cervical paracervical nerve block anesthesia. After waiting for 2 minutes, the researcher gently checks the depth of the uterine cavity with a probe and then remove it. After that, the researcher tries to insert a number 10 to 4 metal Hegar dilator in sequence, until passes through the internal cervical orifice without resistance. The nurse connects the disposable cervical dilator to the syringe containing drug. The researcher inserts the disposable cervical dilator into the cervical canal in line with the probe direction, and slowly inject drug from the syringe into it within a minute. The researcher waits for another minute before removing the disposable cervical dilator. After that, the researcher tries to insert a number 10 to 4 metal Hegar dilator in sequence, until passes through the internal cervical orifice without resistance.
The researcher removes the IUD with a ring hook. If necessary, the researcher will use metal Hegar dilators to dilate cervi. The subject uses VAS to evaluate the degree of pain before, during and after surgery. Oral antibiotics were routinely given post-surgery to prevent infection.
- Conditions
- Cervical Dilatations
- Being tested
- Disposable cervical dilator stick combined with lidocaine hydrochloride injection, Disposable cervical dilator stick combined with normal saline injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable cervical dilator stick combined with lidocaine hydrochloride injectionProcedure or surgery
The subject will undergo routine disinfection and receive cervical paracervical nerve block anesthesia (5mL of 1% lidocaine injection at the level of the bilateral sacral ligaments). After waiting for 2 minutes, the researcher gently checks the depth of the uterine cavity with a probe and then remove it. The nurse connects the disposable cervical dilator to the syringe containing lidocaine hydrochloride. The researcher inserts the disposable cervical dilator into the cervical canal in line with the probe direction, and slowly inject drug from the syringe into it within a minute. The researcher waits for another minute before removing the disposable cervical dilator. The researcher removes the IUD with a ring hook. If necessary, the researcher will use metal Hegar dilators to dilate cervix.
Disposable cervical dilator stick combined with normal saline injectionProcedure or surgery
The subject will undergo routine disinfection and receive cervical paracervical nerve block anesthesia (5mL of 1% lidocaine injection at the level of the bilateral sacral ligaments). After waiting for 2 minutes, the researcher gently checks the depth of the uterine cavity with a probe and then remove it. The nurse connects the disposable cervical dilator to the syringe containing normal saline. The researcher inserts the disposable cervical dilator into the cervical canal in line with the probe direction, and slowly inject drug from the syringe into it within a minute. The researcher waits for another minute before removing the disposable cervical dilator. The researcher removes the IUD with a ring hook. If necessary, the researcher will use metal Hegar dilators to dilate cervix.
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Disposable cervical dilator stick combined with lidocaine hydrochloride injection. Receives: Procedure: Disposable cervical dilator stick combined with lidocaine hydrochloride injection |
| Control group | Placebo comparator | Disposable cervical dilator stick combined with normal saline injection. Receives: Procedure: Disposable cervical dilator stick combined with normal saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) pain score
The subject uses VAS to evaluate the degree of pain before surgery. Visual analog scale pain score (VAS score), minimum 0mm, maximum 100mm, higher value means more severe pain.
Measured: Baseline
Visual analog scale (VAS) pain score
The subject uses VAS to evaluate the degree of pain at the most painful time during the surgery. Visual analog scale pain score (VAS score), minimum 0mm, maximum 100mm, higher value means more severe pain.
Measured: Intraoperative
Visual analog scale (VAS) pain score
The subject uses VAS to evaluate the degree of pain 30 minutes after surgery. Visual analog scale pain score (VAS score), minimum 0mm, maximum 100mm, higher value means more severe pain.
Measured: 30 minutes after surgery
Secondary outcomes (2)
Cervical dilatation
Before dilation, the researcher tries to insert a number 10 to 4 metal Hegar dilator in sequence, until passes through the internal cervical orifice without resistance. The researcher records the diameter of the last dilator as the predilated cervical dilation score. The minimum value of cervical dilation is 4, and the maximum value is 10. If the actual dilation of the cervix is not within the measurement range, it is recorded as less than 4 or greater than 10. The larger the value, the greater the degree of cervical dilation.
Measured: Baseline
Cervical dilatation
Within one minute after using the disposable cervical dilator, the researcher tries to insert a number 10 to 4 metal Hegar dilator in sequence, until passes through the internal cervical orifice without resistance. The researcher records the diameter of the last dilator as the postdilated cervical dilation score. The minimum value of cervical dilation is 4, and the maximum value is 10. If the actual dilation of the cervix is not within the measurement range, it is recorded as less than 4 or greater than 10. The larger the value, the greater the degree of cervical dilation.
Measured: Within one minute after using the disposable cervical dilator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start21 Jul 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
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 Cervical DilatationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yahui Yahui, Yahui, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955768
- Sponsor's protocol ID
- 2023001
- Status last verified
- Jun 2023
- First submitted
- 4 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If necessary, other researchers can ask us to share the raw data via email after the results are published.
Publications
Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.
PubMed 25759418Falcone F, Raimondo G, Stark M, Dessole S, Torella M, Raimondo I. Balloon Catheter for Cervical Priming before Operative Hysteroscopy in Young Women: A Pilot Study. J Invest Surg. 2020 Apr;33(4):301-306. doi: 10.1080/08941939.2018.1503379. Epub 2018 Oct 31.
PubMed 30380354Charoenkwan K, Nantasupha C. Methods of pain control during endometrial biopsy: A systematic review and meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2020 Jan;46(1):9-30. doi: 10.1111/jog.14152. Epub 2019 Oct 30.
PubMed 31667985Babandi RM, Agboghoroma OC, Durojaiye KW, Jimoh KO, Essiet EA. Pain Relief for Hysterosalpingography: A Randomized Controlled, Double Blinded Trial Comparing Suppository Diclofenac, Prilocaine/Lignocaine (EMLA) Cream And Placebo. West Afr J Med. 2021 Dec 30;38(12):1174-1182.
PubMed 35035229Abbas AM, Abdellah MS, Khalaf M, Bahloul M, Abdellah NH, Ali MK, Abdelmagied AM. Effect of cervical lidocaine-prilocaine cream on pain perception during copper T380A intrauterine device insertion among parous women: A randomized double-blind controlled trial. Contraception. 2017 Mar;95(3):251-256. doi: 10.1016/j.contraception.2016.10.011. Epub 2016 Nov 4.
PubMed 27823944Veces A, Reyes O. Use of Topical Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Management During Manual Vacuum Aspiration: ADouble-Blind, Randomized, Placebo-Controlled Trial. J Obstet Gynaecol Can. 2019 May;41(5):641-646. doi: 10.1016/j.jogc.2018.05.027. Epub 2018 Oct 26.
PubMed 31007170Wang Y, Chen Q, Liu Z, Chen Y, Zheng Y, Guo J, Zhou F, Lv N, Zhao J, Shen S, Yuan Q, Tong J. Analgesia efficacy of lidocaine transfused by a novel disposable injectable cervical dilator during intrauterine device removal procedure: A randomized clinical trial. Contraception. 2024 Jul;135:110439. doi: 10.1016/j.contraception.2024.110439. Epub 2024 Mar 27.
PubMed 38552820
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Single-use Micro-non-invasive Injection Cervical Dilator"
- ClinicalTrials.gov ID
- NCT05955768
- Acronym / sponsor ID
- 2023001
- Conditions
- Cervical Dilatations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, randomized (each group was assigned 1:1), double-blind controlled trial.
This study aims to investigate if lidocaine injection into the single-use micro-non-invasive injection cervical dilator (short for disposable cervical dilators) leads to better pain control efficacy compared with normal saline injection in intrauterine device(short for IUD) removal surgery. Furthermore, this study aims to compare cervical dilation degree, safety, and patient satisfaction between groups.
Research objects Between August 1, 2023, and August 1, 2025, 74 healthy women who voluntarily request the removal of the intrauterine device under local anesthesia in Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine.
The subjects will be dividied into two groups at random.
- Trial group: disposable cervical dilator stick combined with lidocaine hydrochloride injection.
- Control group: disposable cervical dilator stick combined with normal saline injection.
Intervention measures:
The nurse fill the syringe with 5ml of either 2% lidocaine hydrochloride injection or normal saline based on the group allocation specified. The appearance of the two drugs is indistinguishable after loading.
The subject will undergo routine disinfection and receive cervical paracervical nerve block anesthesia. After waiting for 2 minutes, the researcher gently checks the depth of the uterine cavity with a probe and then remove it. After that, the researcher tries to insert a number 10 to 4 metal Hegar dilator in sequence, until passes through the internal cervical orifice without resistance. The nurse connects the disposable cervical dilator to the syringe containing drug. The researcher inserts the disposable cervical dilator into the cervical canal in line with the probe direction, and slowly inject drug from the syringe into it within a minute. The researcher waits for another minute before removing the disposable cervical dilator. After that, the researcher tries to insert a number 10 to 4 metal Hegar dilator in sequence, until passes through the internal cervical orifice without resistance.
The researcher removes the IUD with a ring hook. If necessary, the researcher will use metal Hegar dilators to dilate cervi. The subject uses VAS to evaluate the degree of pain before, during and after surgery. Oral antibiotics were routinely given post-surgery to prevent infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Procedure: Disposable cervical dilator stick combined with lidocaine hydrochloride injectionDisposable cervical dilator stick combined with lidocaine hydrochloride injection. |
| Control group | Placebo comparator | Procedure: Disposable cervical dilator stick combined with normal saline injectionDisposable cervical dilator stick combined with normal saline injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 and <65 years old;
- Voluntary request for removal of intrauterine device under local anesthesia;
- No known allergic reactions or sensitivity to lidocaine, physiological saline and polyvinyl formaldehyde polymer materials in the past;
- Volunteer participation in this study.
Key exclusion criteria (7 listed)
- Dysplasia of uterine cavity structure;
- Known lesions such as uterine fibroids that compress and cause uterine cavity deformation;
- Presence of untreated acute cervicitis or pelvic inflammatory diseases;
- History of cervical surgery;
- Systemic diseases that can affect pain perception;
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 |
|---|---|---|
| Disposable cervical dilator stick combined with lidocaine hydrochloride injectionThe subject will undergo routine disinfection and receive cervical paracervical nerve block anesthesia (5mL of 1% lidocaine injection at the level of the bilateral sacral ligaments). After waiting for 2 minutes, the researcher gently checks the depth of the uterine cavity with a probe and then remove it. The nurse connects the disposable cervical dilator to the syringe containing lidocaine hydrochloride. The researcher inserts the disposable cervical dilator into the cervical canal in line with the probe direction, and slowly inject drug from the syringe into it within a minute. The researcher waits for another minute before removing the disposable cervical dilator. The researcher removes the IUD with a ring hook. If necessary, the researcher will use metal Hegar dilators to dilate cervix. | Procedure or surgery | Trial group |
| Disposable cervical dilator stick combined with normal saline injectionThe subject will undergo routine disinfection and receive cervical paracervical nerve block anesthesia (5mL of 1% lidocaine injection at the level of the bilateral sacral ligaments). After waiting for 2 minutes, the researcher gently checks the depth of the uterine cavity with a probe and then remove it. The nurse connects the disposable cervical dilator to the syringe containing normal saline. The researcher inserts the disposable cervical dilator into the cervical canal in line with the probe direction, and slowly inject drug from the syringe into it within a minute. The researcher waits for another minute before removing the disposable cervical dilator. The researcher removes the IUD with a ring hook. If necessary, the researcher will use metal Hegar dilators to dilate cervix. | Procedure or surgery | Control group |
Primary outcome
Visual analog scale (VAS) pain score
Time frame: Baseline
The subject uses VAS to evaluate the degree of pain before surgery. Visual analog scale pain score (VAS score), minimum 0mm, maximum 100mm, higher value means more severe pain.
Visual analog scale (VAS) pain score
Time frame: Intraoperative
The subject uses VAS to evaluate the degree of pain at the most painful time during the surgery. Visual analog scale pain score (VAS score), minimum 0mm, maximum 100mm, higher value means more severe pain.
Visual analog scale (VAS) pain score
Time frame: 30 minutes after surgery
The subject uses VAS to evaluate the degree of pain 30 minutes after surgery. Visual analog scale pain score (VAS score), minimum 0mm, maximum 100mm, higher value means more severe pain.
2 secondary outcomes
Cervical dilatation
Time frame: Baseline
Cervical dilatation
Time frame: Within one minute after using the disposable cervical dilator
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Background: PubMed 25759418Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.
- Background: PubMed 30380354Falcone F, Raimondo G, Stark M, Dessole S, Torella M, Raimondo I. Balloon Catheter for Cervical Priming before Operative Hysteroscopy in Young Women: A Pilot Study. J Invest Surg. 2020 Apr;33(4):301-306. doi: 10.1080/08941939.2018.1503379. Epub 2018 Oct 31.
- Background: PubMed 31667985Charoenkwan K, Nantasupha C. Methods of pain control during endometrial biopsy: A systematic review and meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2020 Jan;46(1):9-30. doi: 10.1111/jog.14152. Epub 2019 Oct 30.
- Background: PubMed 35035229Babandi RM, Agboghoroma OC, Durojaiye KW, Jimoh KO, Essiet EA. Pain Relief for Hysterosalpingography: A Randomized Controlled, Double Blinded Trial Comparing Suppository Diclofenac, Prilocaine/Lignocaine (EMLA) Cream And Placebo. West Afr J Med. 2021 Dec 30;38(12):1174-1182.
- Background: PubMed 27823944Abbas AM, Abdellah MS, Khalaf M, Bahloul M, Abdellah NH, Ali MK, Abdelmagied AM. Effect of cervical lidocaine-prilocaine cream on pain perception during copper T380A intrauterine device insertion among parous women: A randomized double-blind controlled trial. Contraception. 2017 Mar;95(3):251-256. doi: 10.1016/j.contraception.2016.10.011. Epub 2016 Nov 4.
- Results publication: PubMed 31007170Veces A, Reyes O. Use of Topical Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Management During Manual Vacuum Aspiration: ADouble-Blind, Randomized, Placebo-Controlled Trial. J Obstet Gynaecol Can. 2019 May;41(5):641-646. doi: 10.1016/j.jogc.2018.05.027. Epub 2018 Oct 26.
- Derived from this study: PubMed 38552820Wang Y, Chen Q, Liu Z, Chen Y, Zheng Y, Guo J, Zhou F, Lv N, Zhao J, Shen S, Yuan Q, Tong J. Analgesia efficacy of lidocaine transfused by a novel disposable injectable cervical dilator during intrauterine device removal procedure: A randomized clinical trial. Contraception. 2024 Jul;135:110439. doi: 10.1016/j.contraception.2024.110439. Epub 2024 Mar 27.
- Individual participant dataSharing planned: No. If necessary, other researchers can ask us to share the raw data via email after the results are published.
Related trials for Cervical Dilatations
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Recruiting
Cervical Ripening Balloons for Same-Day Cervical Prep
Dilation and Evacuation
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
RecruitingPhase 2/3
Anticholinergics for Cervical Edema in Labor
Labor Dystocia
Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Abortion, Second Trimester, Abortion, Medical
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.
Yahui Yahui, Yahui principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable cervical dilator stick combined with lidocaine hydrochloride injection and Disposable cervical dilator stick combined with normal saline injection in people with Cervical Dilatations, run by First People's Hospital of Hangzhou 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 4 inclusion and 7 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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.
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?
Visual analog scale (VAS) pain score (time frame: Baseline). 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 NCT05955768, 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 7 Sep 2023.