Total Hip Arthroplasty (THA)PENG-LFCN-EEGNCT07903740
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
A study testing Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block and EEG-Guided General Anaesthesia in people with Total Hip Arthroplasty (THA), run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized controlled trial aims to evaluate the effects of combined pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks on intraoperative anaesthetic consumption and electroencephalographic (EEG)-derived anaesthetic depth in patients undergoing elective total hip… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block and EEG-Guided General Anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective primary total hip arthroplasty
- Undergoing general anaesthesia
- Provision of written informed consent to participate in the study
Who cannot join
- Known allergy to local anaesthetics
- Contraindications to PENG or LFCN block
- Infection at the planned block injection site
- Coagulopathy or anticoagulant therapy considered unsuitable for regional anaesthesia
- Chronic opioid use
- Significant neurological disorders that may interfere with EEG assessment
Show all 9Show fewer
- Cognitive impairment preventing comprehension of the study protocol or provision of informed consent
- Inability to perform SedLine monitoring
- Inability to obtain written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kocaeli City Hospital
Köseköy, Kocaeli, 41100
AYSE SENCAN, M.D Anaesthesiology Specialist, +905078313235, draysesencan@gmail.com
Ayse Zeynep Turan Civraz, Associated Professor, +905054695850, ayse.zeynep@gmail.com
About this study
Official title: Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
This prospective, randomized controlled trial aims to evaluate the effects of combined pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks on intraoperative anaesthetic consumption and electroencephalographic (EEG)-derived anaesthetic depth in patients undergoing elective total hip arthroplasty.
A total of 50 adult patients will be randomly allocated to two groups: combined PENG and LFCN blocks followed by general anaesthesia, or general anaesthesia alone. Anaesthetic depth will be monitored using the SedLine EEG monitoring system.
Read more
The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include remifentanil consumption, EEG-derived parameters including Patient State Index (PSI) and suppression ratio, haemodynamic variables, and recovery characteristics.
The study aims to determine whether combined regional blocks reduce anaesthetic requirements while maintaining adequate EEG-guided anaesthetic depth.
Read the detailed description
Total hip arthroplasty is frequently associated with significant nociceptive stimulation during surgery. Regional anaesthesia techniques, including the pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, may reduce intraoperative nociceptive input and consequently decrease anaesthetic and opioid requirements.
This prospective, randomized controlled trial will include 50 patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective total hip arthroplasty.
Patients will be randomly assigned in a 1:1 ratio to either an intervention group receiving combined ultrasound-guided PENG and LFCN blocks before general anaesthesia or a control group receiving general anaesthesia without preoperative regional blocks.
General anaesthesia will be administered using a standardized EEG-guided protocol. During induction, propofol will be titrated to achieve a target Patient State Index (PSI) of 25-50, as monitored by the SedLine system. Following tracheal intubation, anaesthesia will be maintained with sevoflurane, with continuous EEG monitoring to maintain the target PSI range.
The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include total remifentanil consumption, EEG-derived anaesthetic depth parameters, suppression ratio measurements, the occurrence and duration of burst suppression, intraoperative haemodynamic variables, and postoperative recovery characteristics.
By comparing anaesthetic consumption and EEG-derived parameters between the two groups, this study aims to evaluate the effects of combined PENG and LFCN blocks on intraoperative anaesthetic requirements and EEG-guided anaesthetic depth during total hip arthroplasty.
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block, EEG-Guided General Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) BlockProcedure or surgery
Ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks will be performed before induction of general anaesthesia. Both blocks will be administered as part of a combined regional anaesthesia technique to provide perioperative analgesia during total hip arthroplasty.
EEG-Guided General AnaesthesiaProcedure or surgery
General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. Remifentanil will be administered intraoperatively according to a standardized anaesthetic protocol.
| Study group | Role | What they receive |
|---|---|---|
| PENG + LFCN Block Group | Experimental | Patients in this group will receive ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks before general anaesthesia. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. Receives: Procedure: Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block |
| No Intervention Group | Active comparator | Patients in this group will undergo general anaesthesia without preoperative peripheral nerve blocks. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. Receives: Procedure: EEG-Guided General Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Sevoflurane Consumption (ml/h)
Intraoperative sevoflurane consumption will be recorded in millilitres (mL) using the anaesthesia workstation. Hourly sevoflurane consumption will be calculated by dividing the total consumption by the duration of sevoflurane administration in hours.
Measured: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Secondary outcomes (7)
Weight-Adjusted Intraoperative Remifentanil Consumption (µg/kg/h)
Weight-adjusted hourly remifentanil consumption will be determined by dividing the total administered remifentanil dose (µg) by patient body weight (kg) and the duration of remifentanil infusion in hours.
Measured: From initiation to discontinuation of remifentanil infusion during general anaesthesia.
Mean Intraoperative Patient State Index (PSI)
The mean Patient State Index (PSI) during sevoflurane anaesthesia will be determined using continuous EEG monitoring data obtained from the SedLine system.
Measured: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Mean Intraoperative Suppression Ratio (SR)
The mean suppression ratio (SR) will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia and expressed as a percentage (%).
Measured: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Percentage of Time With Suppression Ratio Above 5%
The percentage of time during which the suppression ratio (SR) exceeds 5% will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia.
Measured: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Time to Extubation (min)
Time to extubation will be defined as the interval between discontinuation of sevoflurane administration and removal of the endotracheal tube, expressed in minutes.
Measured: From discontinuation of sevoflurane administration until tracheal extubation.
Postoperative Richmond Agitation-Sedation Scale (RASS) Score
Postoperative sedation and agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from -5 (unarousable) to +4 (combative), with 0 indicating an alert and calm state.
Measured: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
Postoperative Nursing Delirium Screening Scale (NuDESC) Score
Postoperative delirium-related symptoms will be assessed using the Nursing Delirium Screening Scale (NuDESC) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from 0 to 10, with higher scores indicating more pronounced delirium-related symptoms.
Measured: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Total Hip Arthroplasty (THA)Studies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903740
- Sponsor's protocol ID
- PENG-LFCN-THA-2026
- Acronym
- PENG-LFCN-EEG
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carella M, Bugada D, Van de Velde M, Beloeil H, Albrecht E, Lavandhomme P, Raeder J, Joshi GP; PROSPECT Working Group of the European Society of Regional Anesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2026 Jul 20. doi: 10.1111/anae.70299. Online ahead of print.
PubMed 42473710Ozturk L, Kesimci E, Albayrak T, Kanbak O. Bispectral index-guided general anaesthesia in combination with interscalene block reduces desflurane consumption in arthroscopic shoulder surgery: a clinical comparison of bupivacaine versus levobupivacaine. BMC Anesthesiol. 2015 Jul 21;15:104. doi: 10.1186/s12871-015-0087-8.
PubMed 26194656Musizza B, Ribaric S. Monitoring the depth of anaesthesia. Sensors (Basel). 2010;10(12):10896-935. doi: 10.3390/s101210896. Epub 2010 Dec 3.
PubMed 22163504Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
PubMed 26275092Pawar N, Barreto Chang OL. Burst Suppression During General Anesthesia and Postoperative Outcomes: Mini Review. Front Syst Neurosci. 2022 Jan 7;15:767489. doi: 10.3389/fnsys.2021.767489. eCollection 2021.
PubMed 35069132
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07903740
- Acronym / sponsor ID
- PENG-LFCN-EEG / PENG-LFCN-THA-2026
- Conditions
- Total Hip Arthroplasty (THA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Oct 2026 (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 prospective, randomized controlled trial aims to evaluate the effects of combined pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks on intraoperative anaesthetic consumption and electroencephalographic (EEG)-derived anaesthetic depth in patients undergoing elective total hip arthroplasty.
A total of 50 adult patients will be randomly allocated to two groups: combined PENG and LFCN blocks followed by general anaesthesia, or general anaesthesia alone. Anaesthetic depth will be monitored using the SedLine EEG monitoring system.
The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include remifentanil consumption, EEG-derived parameters including Patient State Index (PSI) and suppression ratio, haemodynamic variables, and recovery characteristics.
The study aims to determine whether combined regional blocks reduce anaesthetic requirements while maintaining adequate EEG-guided anaesthetic depth.
Detailed description
Total hip arthroplasty is frequently associated with significant nociceptive stimulation during surgery. Regional anaesthesia techniques, including the pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, may reduce intraoperative nociceptive input and consequently decrease anaesthetic and opioid requirements.
This prospective, randomized controlled trial will include 50 patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective total hip arthroplasty.
Patients will be randomly assigned in a 1:1 ratio to either an intervention group receiving combined ultrasound-guided PENG and LFCN blocks before general anaesthesia or a control group receiving general anaesthesia without preoperative regional blocks.
General anaesthesia will be administered using a standardized EEG-guided protocol. During induction, propofol will be titrated to achieve a target Patient State Index (PSI) of 25-50, as monitored by the SedLine system. Following tracheal intubation, anaesthesia will be maintained with sevoflurane, with continuous EEG monitoring to maintain the target PSI range.
The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include total remifentanil consumption, EEG-derived anaesthetic depth parameters, suppression ratio measurements, the occurrence and duration of burst suppression, intraoperative haemodynamic variables, and postoperative recovery characteristics.
By comparing anaesthetic consumption and EEG-derived parameters between the two groups, this study aims to evaluate the effects of combined PENG and LFCN blocks on intraoperative anaesthetic requirements and EEG-guided anaesthetic depth during total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG + LFCN Block Group | Experimental | Procedure: Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) BlockPatients in this group will receive ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks before general anaesthesia. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. |
| No Intervention Group | Active comparator | Procedure: EEG-Guided General AnaesthesiaPatients in this group will undergo general anaesthesia without preoperative peripheral nerve blocks. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective primary total hip arthroplasty
- Undergoing general anaesthesia
- Provision of written informed consent to participate in the study
Key exclusion criteria (9 listed)
- Known allergy to local anaesthetics
- Contraindications to PENG or LFCN block
- Infection at the planned block injection site
- Coagulopathy or anticoagulant therapy considered unsuitable for regional anaesthesia
- Chronic opioid use
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 |
|---|---|---|
| Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) BlockUltrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks will be performed before induction of general anaesthesia. Both blocks will be administered as part of a combined regional anaesthesia technique to provide perioperative analgesia during total hip arthroplasty. | Procedure or surgery | PENG + LFCN Block Group |
| EEG-Guided General AnaesthesiaGeneral anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. Remifentanil will be administered intraoperatively according to a standardized anaesthetic protocol. | Procedure or surgery | No Intervention Group |
Primary outcome
Intraoperative Sevoflurane Consumption (ml/h)
Time frame: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Intraoperative sevoflurane consumption will be recorded in millilitres (mL) using the anaesthesia workstation. Hourly sevoflurane consumption will be calculated by dividing the total consumption by the duration of sevoflurane administration in hours.
7 secondary outcomes
Weight-Adjusted Intraoperative Remifentanil Consumption (µg/kg/h)
Time frame: From initiation to discontinuation of remifentanil infusion during general anaesthesia.
Mean Intraoperative Patient State Index (PSI)
Time frame: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Mean Intraoperative Suppression Ratio (SR)
Time frame: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Percentage of Time With Suppression Ratio Above 5%
Time frame: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Time to Extubation (min)
Time frame: From discontinuation of sevoflurane administration until tracheal extubation.
Postoperative Richmond Agitation-Sedation Scale (RASS) Score
Time frame: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
Postoperative Nursing Delirium Screening Scale (NuDESC) Score
Time frame: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 42473710Carella M, Bugada D, Van de Velde M, Beloeil H, Albrecht E, Lavandhomme P, Raeder J, Joshi GP; PROSPECT Working Group of the European Society of Regional Anesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2026 Jul 20. doi: 10.1111/anae.70299. Online ahead of print.
- Background: PubMed 26194656Ozturk L, Kesimci E, Albayrak T, Kanbak O. Bispectral index-guided general anaesthesia in combination with interscalene block reduces desflurane consumption in arthroscopic shoulder surgery: a clinical comparison of bupivacaine versus levobupivacaine. BMC Anesthesiol. 2015 Jul 21;15:104. doi: 10.1186/s12871-015-0087-8.
- Background: PubMed 22163504Musizza B, Ribaric S. Monitoring the depth of anaesthesia. Sensors (Basel). 2010;10(12):10896-935. doi: 10.3390/s101210896. Epub 2010 Dec 3.
- Background: PubMed 26275092Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
- Background: PubMed 35069132Pawar N, Barreto Chang OL. Burst Suppression During General Anesthesia and Postoperative Outcomes: Mini Review. Front Syst Neurosci. 2022 Jan 7;15:767489. doi: 10.3389/fnsys.2021.767489. eCollection 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block and EEG-Guided General Anaesthesia in people with Total Hip Arthroplasty (THA), run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
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 5 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYSE SENCAN, M.D Anaesthesiology Specialist (+905078313235, draysesencan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Sevoflurane Consumption (ml/h) (time frame: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.). 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 NCT07903740, which also lists 5 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 2026.