Hernia, UmbilicalPhase 2/3NCT07062497
Clonidine in Ultrasound-guided Rectus Sheath Block for Outpatient Umbilical Hernioplasty
A Phase 2/3 study testing Rectus Sheath Block and Rectus Sheath Block with Clonidine in people with Hernia, Umbilical and Clonidine, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
This clinical trial aims to evaluate the effectiveness of an ultrasound-guided nerve block technique as the sole anesthetic method for patients undergoing outpatient umbilical hernia surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hernia, Umbilical, Clonidine, Pain, Postoperative
- What is being tested?
- Rectus Sheath Block and Rectus Sheath Block with Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jan 2025to 30 Apr 2026
- Phase
- Phase 2/3
- 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
- Adults aged 18 to 65 years;
- Both male and female participants;
- ASA physical status I or II (American Society of Anesthesiologists classification);
- Scheduled for elective ambulatory umbilical hernia repair;
- Hernial defect size ≤ 4 cm (small to medium).
Who cannot join
- Refusal or inability to provide written informed consent;
- Cognitive or psychiatric disorders that impair comprehension or adherence to the study protocol;
- Known allergy or hypersensitivity to local anesthetics, clonidine, opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics;
- Participation in another clinical trial within the previous 30 days;
- Missing data or loss to follow-up during postoperative assessments;
- Contraindications to regional anesthesia or known coagulopathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Policlinica Universitária Piquet Carneiro
Rio de Janeiro, Rio de Janeiro, 20950-003
Samuel N Abreu, MD, +55 21 2566-7000, contato.ppc@uerj.br
About this study
Official title: Ultrasound-guided Rectus Abdominis Muscle Sheath Block in Outpatient Umbilical Hernioplasties: a Comparative Analysis of the Use of Clonidine as an Adjuvant - Prospective Randomized Clinical Trial
This clinical trial aims to evaluate the effectiveness of an ultrasound-guided nerve block technique as the sole anesthetic method for patients undergoing outpatient umbilical hernia surgery. The procedure, called rectus sheath block (RSB), involves injecting local anesthetic near the abdominal muscles to reduce pain during and after surgery. The study will compare two groups of adult patients: one receiving the nerve block with a medication called clonidine added to the anesthetic solution, and the other receiving the same block without clonidine. Clonidine may help improve pain control and reduce the need for additional pain medications. By analyzing pain scores, recovery quality, and potential side effects, the study seeks to determine whether the use of clonidine in this context is safe, cost-effective, and beneficial for patient recovery. Participants will answer questionnaires about their pain and recovery during the first 48 hours after surgery.
Read the detailed description
This is a prospective, randomized, double-blind, controlled clinical trial designed to evaluate the effectiveness and safety of adding clonidine to a local anesthetic solution for ultrasound-guided rectus sheath block (RSB) in adult patients undergoing ambulatory umbilical hernioplasty. The study will be conducted at the Ambulatory Surgery Unit of the Policlínica Universitária Piquet Carneiro, part of the Universidade do Estado do Rio de Janeiro (UERJ), between January 2025 and April 2026.
Eligible patients (ASA I or II, aged 18-65) scheduled for elective outpatient umbilical hernia repair with a hernial defect ≤ 4 cm will be randomized into two groups. The intervention group (BRA-CLO) will receive bilateral RSB with a solution containing 8 mL of lidocaine 2%, 8 mL of ropivacaine 1%, and clonidine 75 mcg, diluted in 0.9% saline to a total volume of 20 mL, administered on each side. The control group (BRA) will receive an identical volume and concentration of local anesthetic without the addition of clonidine.
RSB will be performed under real-time ultrasound guidance (Butterfly iQ+ probe) using an in-plane technique with a Quincke 22G needle. Sedation with midazolam, fentanyl, and propofol will be administered as required. The block will be performed preoperatively under standard monitoring, including ECG, pulse oximetry, and non-invasive blood pressure.
The primary hypothesis is that the addition of clonidine will enhance the quality of intraoperative and postoperative analgesia, reduce opioid consumption, and improve overall postoperative recovery without increasing the risk of adverse events. To assess recovery quality, the validated Quality of Recovery-15 (QoR-15) questionnaire will be administered at postoperative 24 and 48 hours. Pain will be assessed using the Numeric Rating Scale (NRS) at predefined intervals (PACU, 24h and 48h). Sedation will be measured with the Richmond Agitation-Sedation Scale (RASS), and adverse events such as bradycardia, nausea, vomiting, conversion to general anesthesia, and postoperative complications will be recorded.
Randomization will be performed using block randomization with variable block sizes (4, 6, or 8) generated in R (v4.4.1), and allocation concealment will be ensured with sealed opaque envelopes. Data will be collected and managed using the REDCap platform, ensuring confidentiality and integrity.
The study aims to fill an important gap in evidence regarding the use of alpha-2 adrenergic agonists as adjuvants in abdominal wall blocks, especially in the context of ambulatory surgery. It is expected that the findings will support the safe and effective use of clonidine to optimize regional anesthesia protocols in hernia repair.
- Conditions
- Hernia, Umbilical, Clonidine, Pain, Postoperative, Ambulatory Surgical Procedures, Regional Anesthesia Block
- Being tested
- Rectus Sheath Block, Rectus Sheath Block with Clonidine
- Keywords
- Rectus Sheath Block, Ultrasound-Guided Regional Anesthesia, Umbilical Hernia Repair, Clonidine, Local Anesthetics, Postoperative Pain Management, Ambulatory Surgery, Quality of Recovery, Alpha-2 Adrenergic Agonists, Pain Measurement, Analgesic Adjuvants
- Medical subject headings
- Hernia, Umbilical, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus Sheath BlockDrug
Also called RSB
Participants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with a solution containing 8 mL of lidocaine 2% + 8 mL of ropivacaine 1%, diluted in 0.9% saline to a total volume of 20 mL, each side, without the addition of clonidine.
Rectus Sheath Block with ClonidineDrug
Also called RSB with clonidine
Participants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with a solution containing 8 mL of lidocaine 2% + 8 mL of ropivacaine 1% + clonidine 75 mcg, diluted in 0.9% saline to a total volume of 20 mL, each side, without the addition of clonidine.
| Study group | Role | What they receive |
|---|---|---|
| Rectus Sheath Block | Active comparator | Participants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) without the addition of clonidine. Receives: Drug: Rectus Sheath Block |
| Rectus sheath block with clonidine | Active comparator | Participants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with clonidine Receives: Drug: Rectus Sheath Block with Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid postoperative consumption
Total amount of opioid analgesics (in milligrams of tramadol equivalents) administered from the end of the surgical procedure to 48 hours postoperatively.
Measured: 48 hours postoperative
Postoperative pain intensity assessed by Numeric Rating Scale (NRS)
Pain scores reported by the patient using the 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain) at each time point.
Measured: At post-anesthesia care unit (PACU) admission (immediately after surgery), 24 hours after surgery, and 48 hours after surgery.
Total intraoperative opioid consumption
Total intraoperative fentanyl consumption
Measured: From induction of anesthesia to the end of surgery.
Secondary outcomes (2)
Quality of recovery assessed by QoR-15 questionnaire
Patient-reported recovery quality measured using the Quality of Recovery-15 (QoR-15) instrument, scored from 0 to 150, with higher scores indicating better recovery.
Measured: At post-anesthesia care unit (PACU) admission (immediately after surgery), 24 hours after surgery, and 48 hours after surgery.
Incidence of postoperative nausea and vomiting (PONV)
Number of patients who experience at least one episode of nausea and/or vomiting in the first 48 hours after surgery.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start7 Jan 2025
- Primary completion16 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hernia, UmbilicalStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-assignment, randomized, double-blind, controlled clinical trial involving two intervention arms. Eligible adult patients undergoing ambulatory umbilical hernia repair are allocated in a 1:1 ratio to receive either ultrasound-guided rectus sheath block (RSB) with local anesthetics alone (control group) or RSB with local anesthetics plus clonidine (intervention group). Randomization is performed using block randomization with variable block sizes to ensure balance between groups. Allocation is concealed through sealed opaque envelopes. Both participants and outcome assessors are blinded to group assignment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Navarro Abreu, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062497
- Sponsor's protocol ID
- 83635224.9.0000.5259
- Other IDs
- 111111111111
- Status last verified
- Dec 2024
- First submitted
- 24 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be made available upon reasonable request to the corresponding author, following appropriate de-identification procedures and in accordance with local ethical guidelines.
Publications
Xuan C, Yan W, Wang D, Li C, Ma H, Mueller A, Wang J. The Facilitatory Effects of Adjuvant Pharmaceutics to Prolong the Duration of Local Anesthetic for Peripheral Nerve Block: A Systematic Review and Network Meta-analysis. Anesth Analg. 2021 Sep 1;133(3):620-629. doi: 10.1213/ANE.0000000000005640.
PubMed 34153021Visoiu M, Scholz S, Malek MM, Carullo PC. The addition of clonidine to ropivacaine in rectus sheath nerve blocks for pediatric patients undergoing laparoscopic appendectomy: A double blinded randomized prospective study. J Clin Anesth. 2021 Aug;71:110254. doi: 10.1016/j.jclinane.2021.110254. Epub 2021 Mar 19.
PubMed 33752119Kwon HJ, Kim YJ, Kim Y, Kim S, Cho H, Lee JH, Kim DH, Jeong SM. Complications and Technical Consideration of Ultrasound-Guided Rectus Sheath Blocks: A Retrospective Analysis of 4033 Patients. Anesth Analg. 2023 Feb 1;136(2):365-372. doi: 10.1213/ANE.0000000000006282. Epub 2022 Nov 29.
PubMed 36638514Cucchiaro G, Ganesh A. The effects of clonidine on postoperative analgesia after peripheral nerve blockade in children. Anesth Analg. 2007 Mar;104(3):532-7. doi: 10.1213/01.ane.0000253548.97479.b8.
PubMed 17312203
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Rectus Abdominis Muscle Sheath Block in Outpatient Umbilical Hernioplasties: a Comparative Analysis of the Use of Clonidine as an Adjuvant - Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07062497
- Acronym / sponsor ID
- 83635224.9.0000.5259
- Conditions
- Hernia, Umbilical, Clonidine, Pain, Postoperative, Ambulatory Surgical Procedures, Regional Anesthesia Block
- Keywords
- Rectus Sheath Block, Ultrasound-Guided Regional Anesthesia, Umbilical Hernia Repair, Clonidine, Local Anesthetics, Postoperative Pain Management, Ambulatory Surgery, Quality of Recovery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 16 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 14 Jul 2025 (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 clinical trial aims to evaluate the effectiveness of an ultrasound-guided nerve block technique as the sole anesthetic method for patients undergoing outpatient umbilical hernia surgery. The procedure, called rectus sheath block (RSB), involves injecting local anesthetic near the abdominal muscles to reduce pain during and after surgery. The study will compare two groups of adult patients: one receiving the nerve block with a medication called clonidine added to the anesthetic solution, and the other receiving the same block without clonidine. Clonidine may help improve pain control and reduce the need for additional pain medications. By analyzing pain scores, recovery quality, and potential side effects, the study seeks to determine whether the use of clonidine in this context is safe, cost-effective, and beneficial for patient recovery. Participants will answer questionnaires about their pain and recovery during the first 48 hours after surgery.
Detailed description
This is a prospective, randomized, double-blind, controlled clinical trial designed to evaluate the effectiveness and safety of adding clonidine to a local anesthetic solution for ultrasound-guided rectus sheath block (RSB) in adult patients undergoing ambulatory umbilical hernioplasty. The study will be conducted at the Ambulatory Surgery Unit of the Policlínica Universitária Piquet Carneiro, part of the Universidade do Estado do Rio de Janeiro (UERJ), between January 2025 and April 2026.
Eligible patients (ASA I or II, aged 18-65) scheduled for elective outpatient umbilical hernia repair with a hernial defect ≤ 4 cm will be randomized into two groups. The intervention group (BRA-CLO) will receive bilateral RSB with a solution containing 8 mL of lidocaine 2%, 8 mL of ropivacaine 1%, and clonidine 75 mcg, diluted in 0.9% saline to a total volume of 20 mL, administered on each side. The control group (BRA) will receive an identical volume and concentration of local anesthetic without the addition of clonidine.
RSB will be performed under real-time ultrasound guidance (Butterfly iQ+ probe) using an in-plane technique with a Quincke 22G needle. Sedation with midazolam, fentanyl, and propofol will be administered as required. The block will be performed preoperatively under standard monitoring, including ECG, pulse oximetry, and non-invasive blood pressure.
The primary hypothesis is that the addition of clonidine will enhance the quality of intraoperative and postoperative analgesia, reduce opioid consumption, and improve overall postoperative recovery without increasing the risk of adverse events. To assess recovery quality, the validated Quality of Recovery-15 (QoR-15) questionnaire will be administered at postoperative 24 and 48 hours. Pain will be assessed using the Numeric Rating Scale (NRS) at predefined intervals (PACU, 24h and 48h). Sedation will be measured with the Richmond Agitation-Sedation Scale (RASS), and adverse events such as bradycardia, nausea, vomiting, conversion to general anesthesia, and postoperative complications will be recorded.
Randomization will be performed using block randomization with variable block sizes (4, 6, or 8) generated in R (v4.4.1), and allocation concealment will be ensured with sealed opaque envelopes. Data will be collected and managed using the REDCap platform, ensuring confidentiality and integrity.
The study aims to fill an important gap in evidence regarding the use of alpha-2 adrenergic agonists as adjuvants in abdominal wall blocks, especially in the context of ambulatory surgery. It is expected that the findings will support the safe and effective use of clonidine to optimize regional anesthesia protocols in hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a parallel-assignment, randomized, double-blind, controlled clinical trial involving two intervention arms. Eligible adult patients undergoing ambulatory umbilical hernia repair are allocated in a 1:1 ratio to receive either ultrasound-guided rectus sheath block (RSB) with local anesthetics alone (control group) or RSB with local anesthetics plus clonidine (intervention group). Randomization is performed using block randomization with variable block sizes to ensure balance between groups. Allocation is concealed through sealed opaque envelopes. Both participants and outcome assessors are blinded to group assignment.
| Arm | Type | Receives |
|---|---|---|
| Rectus Sheath Block | Active comparator | Drug: Rectus Sheath BlockParticipants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) without the addition of clonidine. |
| Rectus sheath block with clonidine | Active comparator | Drug: Rectus Sheath Block with ClonidineParticipants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with clonidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years;
- Both male and female participants;
- ASA physical status I or II (American Society of Anesthesiologists classification);
- Scheduled for elective ambulatory umbilical hernia repair;
- Hernial defect size ≤ 4 cm (small to medium).
Key exclusion criteria (6 listed)
- Refusal or inability to provide written informed consent;
- Cognitive or psychiatric disorders that impair comprehension or adherence to the study protocol;
- Known allergy or hypersensitivity to local anesthetics, clonidine, opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics;
- Participation in another clinical trial within the previous 30 days;
- Missing data or loss to follow-up during postoperative assessments;
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 |
|---|---|---|
| Rectus Sheath BlockAlso: RSBParticipants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with a solution containing 8 mL of lidocaine 2% + 8 mL of ropivacaine 1%, diluted in 0.9% saline to a total volume of 20 mL, each side, without the addition of clonidine. | Drug | Rectus Sheath Block |
| Rectus Sheath Block with ClonidineAlso: RSB with clonidineParticipants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with a solution containing 8 mL of lidocaine 2% + 8 mL of ropivacaine 1% + clonidine 75 mcg, diluted in 0.9% saline to a total volume of 20 mL, each side, without the addition of clonidine. | Drug | Rectus sheath block with clonidine |
Primary outcome
Total opioid postoperative consumption
Time frame: 48 hours postoperative
Total amount of opioid analgesics (in milligrams of tramadol equivalents) administered from the end of the surgical procedure to 48 hours postoperatively.
Postoperative pain intensity assessed by Numeric Rating Scale (NRS)
Time frame: At post-anesthesia care unit (PACU) admission (immediately after surgery), 24 hours after surgery, and 48 hours after surgery.
Pain scores reported by the patient using the 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain) at each time point.
Total intraoperative opioid consumption
Time frame: From induction of anesthesia to the end of surgery.
Total intraoperative fentanyl consumption
2 secondary outcomes
Quality of recovery assessed by QoR-15 questionnaire
Time frame: At post-anesthesia care unit (PACU) admission (immediately after surgery), 24 hours after surgery, and 48 hours after surgery.
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 48 hours postoperatively
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 14 Jul 2025.
- Background: PubMed 34153021Xuan C, Yan W, Wang D, Li C, Ma H, Mueller A, Wang J. The Facilitatory Effects of Adjuvant Pharmaceutics to Prolong the Duration of Local Anesthetic for Peripheral Nerve Block: A Systematic Review and Network Meta-analysis. Anesth Analg. 2021 Sep 1;133(3):620-629. doi: 10.1213/ANE.0000000000005640.
- Background: PubMed 33752119Visoiu M, Scholz S, Malek MM, Carullo PC. The addition of clonidine to ropivacaine in rectus sheath nerve blocks for pediatric patients undergoing laparoscopic appendectomy: A double blinded randomized prospective study. J Clin Anesth. 2021 Aug;71:110254. doi: 10.1016/j.jclinane.2021.110254. Epub 2021 Mar 19.
- Background: PubMed 36638514Kwon HJ, Kim YJ, Kim Y, Kim S, Cho H, Lee JH, Kim DH, Jeong SM. Complications and Technical Consideration of Ultrasound-Guided Rectus Sheath Blocks: A Retrospective Analysis of 4033 Patients. Anesth Analg. 2023 Feb 1;136(2):365-372. doi: 10.1213/ANE.0000000000006282. Epub 2022 Nov 29.
- Results publication: PubMed 17312203Cucchiaro G, Ganesh A. The effects of clonidine on postoperative analgesia after peripheral nerve blockade in children. Anesth Analg. 2007 Mar;104(3):532-7. doi: 10.1213/01.ane.0000253548.97479.b8.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available upon reasonable request to the corresponding author, following appropriate de-identification procedures and in accordance with local ethical guidelines.
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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 Phase 2/3 study testing Rectus Sheath Block and Rectus Sheath Block with Clonidine in people with Hernia, Umbilical and Clonidine, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 6 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: looking for participants now, as of the sponsor's last update on 14 Jul 2025. 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 Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Samuel N Abreu, MD (55 21 987901911, samuel.abreu@ppc.uerj.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid postoperative consumption (time frame: 48 hours postoperative). 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 NCT07062497, which also lists 4 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 14 Jul 2025.