Nitrous OxideEarly Phase 1NO2NCT06661005
Nitrous Oxide for Pain Management During In-Office Gynecology Procedures
A Early Phase 1 study testing Nitrous oxide and IV Sedation in people with Nitrous Oxide, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pain control, patient satisfaction, and efficiency of nitrous oxide used for anesthesia during in-office gynecologic procedures compared to IV sedation. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nitrous Oxide
- What is being tested?
- Nitrous oxide and IV Sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 1 Sep 2021
- Phase
- Early Phase 1
- 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 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Negative UPT
- English speaking,
- At the Banner Women's Institute who are consented for any of the following procedures with sedation: Diagnostic hysteroscopy, Hysteroscopic endometrial biopsy, Hysteroscopy, IUD placement, Hysteroscopic IUD removal, Colposcopy, LEEP
Who cannot join
- Chronic narcotic use,
- Contraindications to Nitrous oxide (i.e. Vit B12 deficiency, pulmonary disease),
- Indication for general anesthesia in the main operating room
- BMI >40
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
The purpose of this study is to evaluate the pain control, patient satisfaction, and efficiency of nitrous oxide used for anesthesia during in-office gynecologic procedures compared to IV sedation. IV sedation for office-based gynecology procedures provides effective anesthesia but requires a recovery time, IV placement, and a ride provided for the patient. Nitrous oxide can be a viable alternative to IV sedation while also reducing recovery time and omitting the need for an IV, NPO status, and a ride home.
Read the detailed description
Many hysteroscopic procedures require only minimal sedation in order to accomplish adequate pain control and sufficient anesthesia for completion of the procedure. In order to avoid the higher costs and time associated with hospital-based procedures, there is a growing trend to complete these procedures in an office-based setting with IV sedation. With IV sedation, the patients are required to have a ride to and from the appointment, maintain an NPO status for at least 8 hours prior to the appointment, receive proper IV placement prior to the procedure, and remain in the recovery area until anesthesia has worn off, which can take 30 minutes to 1 hour. Several studies in the family planning literature have shown promising results using nitrous oxide for anesthesia during simple in-office procedures such as **. One pilot study from Madrid demonstrated superior pain control with nitrous oxide when compared to **.
We believe that nitrous oxide can be a safe, effective, and favorable method for anesthesia for quick and simple office-based gynecologic procedures. Not only will nitrous oxide provide an equal level of pain control, but it also provides several benefits to the patient and the physician. Using nitrous oxide will not require the patient to withstand an uncomfortable IV placement, to maintain NPO status prior to the procedure, or to coordinate a ride before and after the procedure. For the physician, using nitrous oxide for procedures will provide quicker recovery times, allowing physicians to potentially provide services to more patients within a single clinic day.
Nitrous oxide (N2O) was first isolated in 1772 by the English chemist Joseph Priestly and was later discovered to have analgesic properties by Humphry Davy almost twenty years later (Boyle, Goerig, Huang, Priestly). Its role as an analgesic did not take hold until 1863 when Gardner Quincy Colton established the use of nitrous oxide for dental procedures. After its introduction to dentistry, N2O soon became a popular form of pain management in both obstetrics and surgery (Goerig, Huang, Smith).
Nitrous oxide, when inhaled, has both analgesic and anesthetic properties. The exact anesthetic mechanism of action is not completely understood but is thought to be due to non-competitive inhibition of the excitatory NMDA subtype glutamate receptors (Jevtovic). Nitrous oxide provides analgesia by stimulating opioid receptors in the periaqueductal gray matter and noradrenergic receptors in the brainstem, causing a release of endogenous opioids. This release of endogenous opioids dis-inhibits noradrenergic neurons in the brainstem by inhibiting the inhibiting GABA receptors. Consequently, norepinephrine is released into the spinal cord, thereby inhibiting pain signaling (Fujinaga, Sanders).
Although nitrous oxide has been documented as a safe and effective method for pain relief in many areas of medicine, specifically obstetrics, little research exists about its use for pain management for in-office gynecologic procedures. One study by Singh et al evaluated the role of Nitrous Oxide vs no intervention for IUD insertion in nulliparous women and found that nitrous oxide did not reduce pain (Singh). A pilot study by Rubido et al examined nitrous oxide versus no intervention versus paracervical block in women undergoing hysteroscopic polypectomy and found that nitrous oxide outperformed both the control group and paracervical group (Rubido). A third randomized controlled trial studied the superiority of nitrous oxide versus oral analgesia and discovered that nitrous oxide significantly reduced pain scores compared to the control group (Schneider). The purpose of this study is to examine the non-inferiority of nitrous oxide to intravenous sedation for pain management during in-office gynecologic procedures.
- Conditions
- Nitrous Oxide
- Being tested
- Nitrous oxide, IV Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous oxideDrug
The Nitrous oxide group will receive instructions to arrive at clinic 30 minutes before her procedure in order to sign consent forms. She will not be given instructions to remain NPO and will not be required to have someone bring her to and from the appointment. No IV will be placed. Anesthesia induction will be done by an anesthesiologist with a nitrous oxygen mixture at a 70:30 ratio
IV SedationDrug
Anesthesia induction will be done by an anesthesiologist with propofol per standard protocol. A pulse oximeter will be placed and oxygen will be administered through a nasal cannula and the patient will be instructed to breath.
| Study group | Role | What they receive |
|---|---|---|
| Nitrous Day | Experimental | The Nitrous group will receive instructions to arrive at clinic 30 minutes before her procedure in order to sign consent forms. She will not be given instructions to remain NPO and will not be required to have someone bring her to and from the appointment. No IV will be placed. Anesthesia induction will be done by an anesthesiologist with a nitrous oxygen mixture at a 70:30 ratio Receives: Drug: Nitrous oxide |
| IV Sedation Day | Active comparator | The IV sedation group will receive instructions to arrive at clinic 1 hour before her procedure in order to sign consent forms and have an IV placed. She will be given instructions to remain NPO status at least 8 hours prior to the procedure and will need someone to bring her to and from the appointment. Anesthesia induction will be done by an anesthesiologist with propofol per standard protocol. Receives: Drug: IV Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Evaluation
Post procedure, patients will be asked to rate their pain using the VASscale, with 0 indicating no pain, to 10 indicating worst possible, unbearable, excruciating pain.
Measured: Procedure start time to procedure end time.
Patient Satisfaction
Post procedure, patients will be asked to rate their satisfaction using the following scale: Very dissatisfied, Dissatisfied, Neutral, Satisfied, or Very Satisfied
Measured: Procedure start time to procedure end time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start17 May 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: The study team didn't have the nitrous oxide to conduct the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nitrous OxideStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patient will be consented for the study at their office visit when the decision is made to schedule them for a procedure meeting inclusion criteria for our study. After the patient is consented, they will be randomized to either nitrous oxide or IV sedation. Depending on their randomization group, they will be scheduled on a "Nitrous Day" or an "IV Sedation Day".
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661005
- Sponsor's protocol ID
- 2008947582
- Acronym
- NO2
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boyle HE. NITROUS OXIDE: HISTORY AND DEVELOPMENT. Br Med J. 1934 Jan 27;1(3812):153-5. doi: 10.1136/bmj.1.3812.153. No abstract available.
PubMed 20778037Fujinaga M, Maze M. Neurobiology of nitrous oxide-induced antinociceptive effects. Mol Neurobiol. 2002 Apr;25(2):167-89. doi: 10.1385/MN:25:2:167.
PubMed 11936558Goerig M, Esch JSA. History of nitrous oxide-with special reference to its early use in Germany. Best Practice & Research Clinical Anaesthesiology. 2001;15(3):313-338.
Huang C, Johnson N. Nitrous Oxide, From the Operating Room to the Emergency Department. Curr Emerg Hosp Med Rep. 2016;4:11-18. doi: 10.1007/s40138-016-0092-3. Epub 2016 Mar 22.
PubMed 27073749Jevtovic-Todorovic V, Todorovic SM, Mennerick S, Powell S, Dikranian K, Benshoff N, Zorumski CF, Olney JW. Nitrous oxide (laughing gas) is an NMDA antagonist, neuroprotectant and neurotoxin. Nat Med. 1998 Apr;4(4):460-3. doi: 10.1038/nm0498-460.
PubMed 9546794Del Valle Rubido C, Solano Calvo JA, Rodriguez Miguel A, Delgado Espeja JJ, Gonzalez Hinojosa J, Zapico Goni A. Inhalation analgesia with nitrous oxide versus other analgesic techniques in hysteroscopic polypectomy: a pilot study. J Minim Invasive Gynecol. 2015 May-Jun;22(4):595-600. doi: 10.1016/j.jmig.2015.01.005. Epub 2015 Jan 14.
PubMed 25596171Sanders RD, Weimann J, Maze M. Biologic effects of nitrous oxide: a mechanistic and toxicologic review. Anesthesiology. 2008 Oct;109(4):707-22. doi: 10.1097/ALN.0b013e3181870a17.
PubMed 18813051Schneider EN, Riley R, Espey E, Mishra SI, Singh RH. Nitrous oxide for pain management during in-office hysteroscopic sterilization: a randomized controlled trial. Contraception. 2017 Mar;95(3):239-244. doi: 10.1016/j.contraception.2016.09.006. Epub 2016 Sep 9.
PubMed 27621048Singh RH, Thaxton L, Carr S, Leeman L, Schneider E, Espey E. A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women. Int J Gynaecol Obstet. 2016 Nov;135(2):145-148. doi: 10.1016/j.ijgo.2016.04.014. Epub 2016 Jul 16.
PubMed 27481016Smith W. Under the influence. A history of nitrous oxide and oxygen Anesthesia. Park Ridge: The Wood Library Museum of Anesthesiology; 1982
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrous Oxide for Pain Management During In-Office Gynecology Procedures
- ClinicalTrials.gov ID
- NCT06661005
- Acronym / sponsor ID
- NO2 / 2008947582
- Conditions
- Nitrous Oxide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study team didn't have the nitrous oxide to conduct the study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 28 Oct 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.
The purpose of this study is to evaluate the pain control, patient satisfaction, and efficiency of nitrous oxide used for anesthesia during in-office gynecologic procedures compared to IV sedation. IV sedation for office-based gynecology procedures provides effective anesthesia but requires a recovery time, IV placement, and a ride provided for the patient. Nitrous oxide can be a viable alternative to IV sedation while also reducing recovery time and omitting the need for an IV, NPO status, and a ride home.
Detailed description
Many hysteroscopic procedures require only minimal sedation in order to accomplish adequate pain control and sufficient anesthesia for completion of the procedure. In order to avoid the higher costs and time associated with hospital-based procedures, there is a growing trend to complete these procedures in an office-based setting with IV sedation. With IV sedation, the patients are required to have a ride to and from the appointment, maintain an NPO status for at least 8 hours prior to the appointment, receive proper IV placement prior to the procedure, and remain in the recovery area until anesthesia has worn off, which can take 30 minutes to 1 hour. Several studies in the family planning literature have shown promising results using nitrous oxide for anesthesia during simple in-office procedures such as **. One pilot study from Madrid demonstrated superior pain control with nitrous oxide when compared to **.
We believe that nitrous oxide can be a safe, effective, and favorable method for anesthesia for quick and simple office-based gynecologic procedures. Not only will nitrous oxide provide an equal level of pain control, but it also provides several benefits to the patient and the physician. Using nitrous oxide will not require the patient to withstand an uncomfortable IV placement, to maintain NPO status prior to the procedure, or to coordinate a ride before and after the procedure. For the physician, using nitrous oxide for procedures will provide quicker recovery times, allowing physicians to potentially provide services to more patients within a single clinic day.
Nitrous oxide (N2O) was first isolated in 1772 by the English chemist Joseph Priestly and was later discovered to have analgesic properties by Humphry Davy almost twenty years later (Boyle, Goerig, Huang, Priestly). Its role as an analgesic did not take hold until 1863 when Gardner Quincy Colton established the use of nitrous oxide for dental procedures. After its introduction to dentistry, N2O soon became a popular form of pain management in both obstetrics and surgery (Goerig, Huang, Smith).
Nitrous oxide, when inhaled, has both analgesic and anesthetic properties. The exact anesthetic mechanism of action is not completely understood but is thought to be due to non-competitive inhibition of the excitatory NMDA subtype glutamate receptors (Jevtovic). Nitrous oxide provides analgesia by stimulating opioid receptors in the periaqueductal gray matter and noradrenergic receptors in the brainstem, causing a release of endogenous opioids. This release of endogenous opioids dis-inhibits noradrenergic neurons in the brainstem by inhibiting the inhibiting GABA receptors. Consequently, norepinephrine is released into the spinal cord, thereby inhibiting pain signaling (Fujinaga, Sanders).
Although nitrous oxide has been documented as a safe and effective method for pain relief in many areas of medicine, specifically obstetrics, little research exists about its use for pain management for in-office gynecologic procedures. One study by Singh et al evaluated the role of Nitrous Oxide vs no intervention for IUD insertion in nulliparous women and found that nitrous oxide did not reduce pain (Singh). A pilot study by Rubido et al examined nitrous oxide versus no intervention versus paracervical block in women undergoing hysteroscopic polypectomy and found that nitrous oxide outperformed both the control group and paracervical group (Rubido). A third randomized controlled trial studied the superiority of nitrous oxide versus oral analgesia and discovered that nitrous oxide significantly reduced pain scores compared to the control group (Schneider). The purpose of this study is to examine the non-inferiority of nitrous oxide to intravenous sedation for pain management during in-office gynecologic procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patient will be consented for the study at their office visit when the decision is made to schedule them for a procedure meeting inclusion criteria for our study. After the patient is consented, they will be randomized to either nitrous oxide or IV sedation. Depending on their randomization group, they will be scheduled on a "Nitrous Day" or an "IV Sedation Day".
| Arm | Type | Receives |
|---|---|---|
| Nitrous Day | Experimental | Drug: Nitrous oxideThe Nitrous group will receive instructions to arrive at clinic 30 minutes before her procedure in order to sign consent forms. She will not be given instructions to remain NPO and will not be required to have someone bring her to and from the appointment. No IV will be placed. Anesthesia induction will be done by an anesthesiologist with a nitrous oxygen mixture at a 70:30 ratio |
| IV Sedation Day | Active comparator | Drug: IV SedationThe IV sedation group will receive instructions to arrive at clinic 1 hour before her procedure in order to sign consent forms and have an IV placed. She will be given instructions to remain NPO status at least 8 hours prior to the procedure and will need someone to bring her to and from the appointment. Anesthesia induction will be done by an anesthesiologist with propofol per standard protocol. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Negative UPT
- English speaking,
- At the Banner Women's Institute who are consented for any of the following procedures with sedation: Diagnostic hysteroscopy, Hysteroscopic endometrial biopsy, Hysteroscopy, IUD placement, Hysteroscopic IUD removal, Colposcopy, LEEP
Key exclusion criteria (5 listed)
- Chronic narcotic use,
- Contraindications to Nitrous oxide (i.e. Vit B12 deficiency, pulmonary disease),
- Indication for general anesthesia in the main operating room
- BMI >40
- Non-English Speaking
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 |
|---|---|---|
| Nitrous oxideThe Nitrous oxide group will receive instructions to arrive at clinic 30 minutes before her procedure in order to sign consent forms. She will not be given instructions to remain NPO and will not be required to have someone bring her to and from the appointment. No IV will be placed. Anesthesia induction will be done by an anesthesiologist with a nitrous oxygen mixture at a 70:30 ratio | Drug | Nitrous Day |
| IV SedationAnesthesia induction will be done by an anesthesiologist with propofol per standard protocol. A pulse oximeter will be placed and oxygen will be administered through a nasal cannula and the patient will be instructed to breath. | Drug | IV Sedation Day |
Primary outcome
Pain Evaluation
Time frame: Procedure start time to procedure end time.
Post procedure, patients will be asked to rate their pain using the VASscale, with 0 indicating no pain, to 10 indicating worst possible, unbearable, excruciating pain.
Patient Satisfaction
Time frame: Procedure start time to procedure end time.
Post procedure, patients will be asked to rate their satisfaction using the following scale: Very dissatisfied, Dissatisfied, Neutral, Satisfied, or Very Satisfied
Results and safety
The study was stopped early (reason given: The study team didn't have the nitrous oxide to conduct the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Background: PubMed 20778037Boyle HE. NITROUS OXIDE: HISTORY AND DEVELOPMENT. Br Med J. 1934 Jan 27;1(3812):153-5. doi: 10.1136/bmj.1.3812.153. No abstract available.
- Background: PubMed 11936558Fujinaga M, Maze M. Neurobiology of nitrous oxide-induced antinociceptive effects. Mol Neurobiol. 2002 Apr;25(2):167-89. doi: 10.1385/MN:25:2:167.
- BackgroundGoerig M, Esch JSA. History of nitrous oxide-with special reference to its early use in Germany. Best Practice & Research Clinical Anaesthesiology. 2001;15(3):313-338.
- Background: PubMed 27073749Huang C, Johnson N. Nitrous Oxide, From the Operating Room to the Emergency Department. Curr Emerg Hosp Med Rep. 2016;4:11-18. doi: 10.1007/s40138-016-0092-3. Epub 2016 Mar 22.
- Background: PubMed 9546794Jevtovic-Todorovic V, Todorovic SM, Mennerick S, Powell S, Dikranian K, Benshoff N, Zorumski CF, Olney JW. Nitrous oxide (laughing gas) is an NMDA antagonist, neuroprotectant and neurotoxin. Nat Med. 1998 Apr;4(4):460-3. doi: 10.1038/nm0498-460.
- Background: PubMed 25596171Del Valle Rubido C, Solano Calvo JA, Rodriguez Miguel A, Delgado Espeja JJ, Gonzalez Hinojosa J, Zapico Goni A. Inhalation analgesia with nitrous oxide versus other analgesic techniques in hysteroscopic polypectomy: a pilot study. J Minim Invasive Gynecol. 2015 May-Jun;22(4):595-600. doi: 10.1016/j.jmig.2015.01.005. Epub 2015 Jan 14.
- Background: PubMed 18813051Sanders RD, Weimann J, Maze M. Biologic effects of nitrous oxide: a mechanistic and toxicologic review. Anesthesiology. 2008 Oct;109(4):707-22. doi: 10.1097/ALN.0b013e3181870a17.
- Background: PubMed 27621048Schneider EN, Riley R, Espey E, Mishra SI, Singh RH. Nitrous oxide for pain management during in-office hysteroscopic sterilization: a randomized controlled trial. Contraception. 2017 Mar;95(3):239-244. doi: 10.1016/j.contraception.2016.09.006. Epub 2016 Sep 9.
- Background: PubMed 27481016Singh RH, Thaxton L, Carr S, Leeman L, Schneider E, Espey E. A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women. Int J Gynaecol Obstet. 2016 Nov;135(2):145-148. doi: 10.1016/j.ijgo.2016.04.014. Epub 2016 Jul 16.
- BackgroundSmith W. Under the influence. A history of nitrous oxide and oxygen Anesthesia. Park Ridge: The Wood Library Museum of Anesthesiology; 1982
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing Nitrous oxide and IV Sedation in people with Nitrous Oxide, run by University of Arizona at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 28 Oct 2024. 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study team didn't have the nitrous oxide to conduct the 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?
Pain Evaluation (time frame: Procedure start time to procedure end time.). The study lists 2 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 NCT06661005, which also lists 10 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 28 Oct 2024.