Uniportal Video-assisted Thoracic SurgeryNCT06016777
Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery
A study of Uniportal Video-assisted Thoracic Surgery, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Trial design Despite video-assisted thoracic technology and procedure specific postoperative pain management (PROSPECT) have been promoted through recent years, thoracic surgery is still considered to be one of the most painful of surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uniportal Video-assisted Thoracic Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to 31 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years
- ASA I-IIa
- Early stage lung cancer or intrathoracic tissue biopsy, suitable for elective uVATSb
- Informed consent obtained
Who cannot join
- ASA≥III
- History of intrathoracic or chest wall surgery
- Chronic pain
- Pre-operative analgesic medication use
- NSAIDsc contraindications: aspirin asthma, allergic to NSAIDs, peptic ulcer, liver and kidney insufficiency, high risk of thrombotic events
- Active autoimmune disease
Show all 9Show fewer
- Allergic to local anesthetics
- Severe coagulation dysfunction, contraindicated for nerve block
- Soft tissue infections of the chest wall
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Li Fang Wang, MD
About this study
Official title: Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial
Trial design Despite video-assisted thoracic technology and procedure specific postoperative pain management (PROSPECT) have been promoted through recent years, thoracic surgery is still considered to be one of the most painful of surgical procedures. This study aims to optimize these conditions according to different perioperative analgesic modes recommended at present. This will be a single-blind randomized study to investigate the optimal analgesic effect of thoracic paravertebral block (TPB), erector spinae block (ESB), or sufentanil patient controlled intravenous analgesia (PCIA) for uniportal video-assisted thoracoscopic surgery (uVATS) and using minimally invasive drainage.
Methods One-hundred and two patients undergoing uVATS will be enrolled. Patients will be randomly assigned to PVB group (20mL 0.3% ropivacaine with dexamethasone), ESB group (20mL 0.3% ropivacaine with dexamethasone) or CON group. PCIA with sufentanil will be provided to all patients after surgery. Primary outcome will be total opioid consumption from the end of the surgery to the time of discharge. Secondary outcomes consist of postoperative pain score, postoperative chronic pain, both at rest and during coughing, sensations of touch and pain on the chest wall, non-opioid analgesic drug use, length of stay (LOS), ambulation time, total cost of hospitalization and long-term postoperative analgesia. Adverse reaction to analgesics and adverse event related to regional block will also be recorded.
Read more
Ethics and dissenmination This study is approved by the Ethics Committee of China-Japan Friendship Hospital (ID 2022-KY-127-1). The results will be published in peer-reviewed journals.
Key words: fast-track; Enhanced Recovery After Surgery; uniportal video-assisted thoracoscopic surgery; randomized controlled trial; thoracoscopic; ultrasonic guidance; paravertebral block; erector spinal block
Read the detailed description
This is a prospective, randomized controlled study. Patients who are scheduled for elective uniportal thoracoscopic surgery in our hospital will be enrolled. Patients will be randomly assigned to one of the three groups: ultrasound-guided paravertebral block, ultrasound-guided erector spinae block, or intravenous patient-controlled analgesia pump group. Different nerve block operation schemes will be used in different groups.
In any of the three groups, general anesthesia will be performed according to the standard, and multi-mode analgesic treatment will be appied as the combination of NSAIDs analgesics, opioid analgesics, and postoperative rescue analgesic treatment. Participants will be followed up at 1, 4, 12, 18 hours, on 1, 2, 3, 4, 7 days, and in 1, 2, 3, 4, 6 months after surgery. At each follow-up visit, rest and cough pain level will be recorded, and sense of touch and pain in the chest will be examined. Additional analgesic treatment will be given if necessary.
Comparisons of the postoperative analgesic use, cough and rest pain, ambulation time, length of hospital stay, and hospital costs will be made in the three groups.
- Being tested
- Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump, Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump, Patient-controlled intravenous analgesia pump
- Keywords
- fast-track, Enhanced Recovery After Surgery, uniportal video-assisted thoracoscopic surgery, randomized controlled trial, thoracoscopic; ultrasonic guidance, paravertebral block, erector spinal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pumpProcedure or surgery
Patients in this group will receive ultrasound-guided paraspinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage <5μg/hour.
Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pumpProcedure or surgery
Patients in this group will receive ultrasound-guided erector spinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage <5μg/hour.
Patient-controlled intravenous analgesia pumpProcedure or surgery
Patients in this group will not receive regional block. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage <5μg/hour.
| Study group | Role | What they receive |
|---|---|---|
| PVB+PCIA group | Experimental | Not described Receives: Procedure: Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump; Procedure: Patient-controlled intravenous analgesia pump |
| ESB+PCIA group | Experimental | Not described Receives: Procedure: Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump; Procedure: Patient-controlled intravenous analgesia pump |
| PCIA group | Active comparator | Not described Receives: Procedure: Patient-controlled intravenous analgesia pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
total opioid consumption
total opioid (morphine equivalent/body weight) consumption from the end of the surgery to the time of discharge.
Measured: up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy.
Secondary outcomes (10)
postoperative pain score assessed by Visual Analogue Scale VAS (1-10)
rest and cough pain
Measured: from the time at the end of surgery to 24 weeks after surgery
postoperative pain score assessed by Numeric Rating Scales, NRS (1-10)
rest and cough pain
Measured: from the time at the end of surgery to 24 weeks after surgery
sensations of touch on the chest wall
difference in tactile sense on bilateral chest-wall. Tactile sensation and cold sensation will be measured at four points (<3cm near the incision, and on the other side on the symmetrical chest wall, and at the point of bilateral mid-clavicular-costal arch) with an alcohol-stained cotton swab
Measured: from the time at the end of surgery to 24 weeks after surgery
non-opioid analgesic drug use
number of patients with long-term (≥3 days) use of non-opioid analgesic drug
Measured: from the time at the end of surgery to 24 weeks after surgery
length of stay (LOS)
days of hospital stay
Measured: up to 1 month, LOS is the amount of days the patient spends in the hospital, determined by subtracting the date of admission from the date of discharge
ambulation time
first time of successful activity off bed, the time between the end of surgery to the time of the first successful ambulation
Measured: up to 1 month, ambulation time is the time the patient first ambulated following the surgical procedure
total cost of hospitalization
the in-patients costs total cost of hospitalization=medication cost + hospitalization cost + nursing cost + delay compensation
Measured: up to 1 month, total charges settled on the day of discharge
long-term postoperative analgesia
number of patient who needs long-term postoperative analgesia (≥3 days after discharge)
Measured: from the time at the end of surgery to 24 weeks after surgery
adverse events
Adverse reactions such as dizziness, nausea, vomiting, drowsiness, dyspnea, fatigue, constipation and urinary retention were recorded in detail
Measured: from the time at the end of surgery to 24 weeks after surgery
chest tube removal time
The time from surgery to removal of the chest drainage tube
Measured: from the time at the end of surgery to 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start10 Oct 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uniportal Video-assisted Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a parallel-group, single-blind, randomized controlled trial. Patients are expected to be enrolled in the trial within 8 months. Participants will be randomly assigned to one of the three groups: ultrasound-guided paravertebral block (PVB+PCIA group), ultrasound-guided erector spinae block(ESB+PCIA group) , or intravenous patient-controlled analgesia pump group (PCIA group). Different nerve block operation schemes will be used in different groups.Except for different nerve block schemes, all the participants will have the same methods and choices of medicine for other kinds of rescue analgesia regimens.The participants and the follow-up evaluation doctors are not aware of the group assignment, and the surgeon and anesthesiologist will not know the grouping code until the beginning of the surgery. In this way, the analgesic effect of each subject can be fairly evaluated.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Fang Wang, China-Japan Friendship Hospital
- Investigators
- Zhen Rong ZHANG, Doctor, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016777
- Sponsor's protocol ID
- ChinaJapanFHAnesth2
- Status last verified
- Jan 2024
- First submitted
- 14 Aug 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Security cameras are set up next to both the computer and the cabinet for data storage. The surveillance video will be available only to medical staff and the principal investigator. Access to data will be restricted to authorized personnel, including ethics committee directors, principal investigator and authorized personnel. Access to paper documents as well as electronic data must be registered, with the name of operator and detailed reasons recorded. The results and conclusions of our research will be reported to all the participants, research team, and the public in peer-reviewed journal. The investigators will try to put forward the existing guidelines to further optimization of perioperative anesthesia and analgesia protocol for small-incision thoracic surgery and optimized drainage tube strategy.
Publications
Wang LF, Qi F, Feng HX, Shi YH, Li Y, Zheng MT, Bu T, Li WX, Zhang ZR. Risk and benefit analysis of single-shot nerve block for postoperative analgesia for uniportal video-assisted thoracic surgery (uVATS): a randomized controlled trial. BMC Anesthesiol. 2025 Feb 12;25(1):68. doi: 10.1186/s12871-025-02955-w.
PubMed 39939956Wang LF, Feng HX, Shi YH, Li Y, Zheng MT, Bu T, Zhang ZR. Protocol for a randomised controlled trial: optimisation of perioperative analgesia protocol for uniportal video-assisted thoracoscopic surgery. BMJ Open. 2024 Apr 2;14(4):e079434. doi: 10.1136/bmjopen-2023-079434.
PubMed 38569709
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06016777
- Acronym / sponsor ID
- ChinaJapanFHAnesth2
- Keywords
- fast-track, Enhanced Recovery After Surgery, uniportal video-assisted thoracoscopic surgery, randomized controlled trial, thoracoscopic; ultrasonic guidance, paravertebral block, erector spinal block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 30 Aug 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.
Trial design Despite video-assisted thoracic technology and procedure specific postoperative pain management (PROSPECT) have been promoted through recent years, thoracic surgery is still considered to be one of the most painful of surgical procedures. This study aims to optimize these conditions according to different perioperative analgesic modes recommended at present. This will be a single-blind randomized study to investigate the optimal analgesic effect of thoracic paravertebral block (TPB), erector spinae block (ESB), or sufentanil patient controlled intravenous analgesia (PCIA) for uniportal video-assisted thoracoscopic surgery (uVATS) and using minimally invasive drainage.
Methods One-hundred and two patients undergoing uVATS will be enrolled. Patients will be randomly assigned to PVB group (20mL 0.3% ropivacaine with dexamethasone), ESB group (20mL 0.3% ropivacaine with dexamethasone) or CON group. PCIA with sufentanil will be provided to all patients after surgery. Primary outcome will be total opioid consumption from the end of the surgery to the time of discharge. Secondary outcomes consist of postoperative pain score, postoperative chronic pain, both at rest and during coughing, sensations of touch and pain on the chest wall, non-opioid analgesic drug use, length of stay (LOS), ambulation time, total cost of hospitalization and long-term postoperative analgesia. Adverse reaction to analgesics and adverse event related to regional block will also be recorded.
Ethics and dissenmination This study is approved by the Ethics Committee of China-Japan Friendship Hospital (ID 2022-KY-127-1). The results will be published in peer-reviewed journals.
Key words: fast-track; Enhanced Recovery After Surgery; uniportal video-assisted thoracoscopic surgery; randomized controlled trial; thoracoscopic; ultrasonic guidance; paravertebral block; erector spinal block
Detailed description
This is a prospective, randomized controlled study. Patients who are scheduled for elective uniportal thoracoscopic surgery in our hospital will be enrolled. Patients will be randomly assigned to one of the three groups: ultrasound-guided paravertebral block, ultrasound-guided erector spinae block, or intravenous patient-controlled analgesia pump group. Different nerve block operation schemes will be used in different groups.
In any of the three groups, general anesthesia will be performed according to the standard, and multi-mode analgesic treatment will be appied as the combination of NSAIDs analgesics, opioid analgesics, and postoperative rescue analgesic treatment. Participants will be followed up at 1, 4, 12, 18 hours, on 1, 2, 3, 4, 7 days, and in 1, 2, 3, 4, 6 months after surgery. At each follow-up visit, rest and cough pain level will be recorded, and sense of touch and pain in the chest will be examined. Additional analgesic treatment will be given if necessary.
Comparisons of the postoperative analgesic use, cough and rest pain, ambulation time, length of hospital stay, and hospital costs will be made in the three groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This will be a parallel-group, single-blind, randomized controlled trial. Patients are expected to be enrolled in the trial within 8 months. Participants will be randomly assigned to one of the three groups: ultrasound-guided paravertebral block (PVB+PCIA group), ultrasound-guided erector spinae block(ESB+PCIA group) , or intravenous patient-controlled analgesia pump group (PCIA group). Different nerve block operation schemes will be used in different groups.Except for different nerve block schemes, all the participants will have the same methods and choices of medicine for other kinds of rescue analgesia regimens.The participants and the follow-up evaluation doctors are not aware of the group assignment, and the surgeon and anesthesiologist will not know the grouping code until the beginning of the surgery. In this way, the analgesic effect of each subject can be fairly evaluated.
| Arm | Type | Receives |
|---|---|---|
| PVB+PCIA group | Experimental | Procedure: Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump, Procedure: Patient-controlled intravenous analgesia pump |
| ESB+PCIA group | Experimental | Procedure: Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump, Procedure: Patient-controlled intravenous analgesia pump |
| PCIA group | Active comparator | Procedure: Patient-controlled intravenous analgesia pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years
- ASA I-IIa
- Early stage lung cancer or intrathoracic tissue biopsy, suitable for elective uVATSb
- Informed consent obtained
Key exclusion criteria (9 listed)
- ASA≥III
- History of intrathoracic or chest wall surgery
- Chronic pain
- Pre-operative analgesic medication use
- NSAIDsc contraindications: aspirin asthma, allergic to NSAIDs, peptic ulcer, liver and kidney insufficiency, high risk of thrombotic events
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 |
|---|---|---|
| Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pumpPatients in this group will receive ultrasound-guided paraspinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage <5μg/hour. | Procedure or surgery | PVB+PCIA group |
| Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pumpPatients in this group will receive ultrasound-guided erector spinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage <5μg/hour. | Procedure or surgery | ESB+PCIA group |
| Patient-controlled intravenous analgesia pumpPatients in this group will not receive regional block. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage <5μg/hour. | Procedure or surgery | ESB+PCIA group, PCIA group, PVB+PCIA group |
Primary outcome
total opioid consumption
Time frame: up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy.
total opioid (morphine equivalent/body weight) consumption from the end of the surgery to the time of discharge.
10 secondary outcomes
postoperative pain score assessed by Visual Analogue Scale VAS (1-10)
Time frame: from the time at the end of surgery to 24 weeks after surgery
postoperative pain score assessed by Numeric Rating Scales, NRS (1-10)
Time frame: from the time at the end of surgery to 24 weeks after surgery
sensations of touch on the chest wall
Time frame: from the time at the end of surgery to 24 weeks after surgery
non-opioid analgesic drug use
Time frame: from the time at the end of surgery to 24 weeks after surgery
length of stay (LOS)
Time frame: up to 1 month, LOS is the amount of days the patient spends in the hospital, determined by subtracting the date of admission from the date of discharge
ambulation time
Time frame: up to 1 month, ambulation time is the time the patient first ambulated following the surgical procedure
total cost of hospitalization
Time frame: up to 1 month, total charges settled on the day of discharge
long-term postoperative analgesia
Time frame: from the time at the end of surgery to 24 weeks after surgery
adverse events
Time frame: from the time at the end of surgery to 24 weeks after surgery
chest tube removal time
Time frame: from the time at the end of surgery to 24 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Derived from this study: PubMed 39939956Wang LF, Qi F, Feng HX, Shi YH, Li Y, Zheng MT, Bu T, Li WX, Zhang ZR. Risk and benefit analysis of single-shot nerve block for postoperative analgesia for uniportal video-assisted thoracic surgery (uVATS): a randomized controlled trial. BMC Anesthesiol. 2025 Feb 12;25(1):68. doi: 10.1186/s12871-025-02955-w.
- Derived from this study: PubMed 38569709Wang LF, Feng HX, Shi YH, Li Y, Zheng MT, Bu T, Zhang ZR. Protocol for a randomised controlled trial: optimisation of perioperative analgesia protocol for uniportal video-assisted thoracoscopic surgery. BMJ Open. 2024 Apr 2;14(4):e079434. doi: 10.1136/bmjopen-2023-079434.
- Individual participant dataSharing planned: Undecided. Security cameras are set up next to both the computer and the cabinet for data storage. The surveillance video will be available only to medical staff and the principal investigator. Access to data will be restricted to authorized personnel, including ethics committee directors, principal investigator and authorized personnel. Access to paper documents as well as electronic data must be registered, with the name of operator and detailed reasons recorded. The results and conclusions of our research will be reported to all the participants, research team, and the public in peer-reviewed journal. The investigators will try to put forward the existing guidelines to further optimization of perioperative anesthesia and analgesia protocol for small-incision thoracic surgery and optimized drainage tube strategy.
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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.
Zhen Rong ZHANG, Doctor study director
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Uniportal Video-assisted Thoracic Surgery, run by China-Japan Friendship Hospital 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 9 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 29 Jan 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 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 Li Fang WANG, Doctor (+8615011393879, lilythewolf@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total opioid consumption (time frame: up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy.). 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 NCT06016777, which also lists 2 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 29 Jan 2024.