Breast CancerSPSIP-ESPBNCT07446868
Ultrasound-Guided SPSIP Versus ESPB for Postoperative Pain After Modified Radical Mastectomy
A study testing Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block in people with Breast Cancer and Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Breast cancer is the most common cancer affecting women worldwide. Modified radical mastectomy is one of the main surgical treatments for breast cancer. However, this surgery is often associated with significant postoperative pain, which may delay recovery and increase the need for opioid medications such as morphine. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Postoperative Pain, Acute Post-surgical Pain
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Apr 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients diagnosed with breast cancer
- Scheduled for modified radical mastectomy (MRM)
- American Society of Anesthesiologists (ASA) physical status II or III
- Age 18-65 years
- Body mass index (BMI) > 20 kg/m² and < 35 kg/m²
- Ability to understand the study protocol and provide written informed consent
Who cannot join
- Patient refusal to participate
- ASA physical status IV or higher
- BMI ≤ 20 kg/m² or ≥ 35 kg/m²
- Known hypersensitivity or contraindication to local anesthetics, opioids, or study medications
- History of chronic pain or regular opioid use
- Significant psychiatric disorders affecting pain assessment
- Contraindications to regional anesthesia (e.g., infection at injection site, coagulopathy, pre-existing peripheral neuropathy)
- Severe respiratory, cardiac, hepatic, or renal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute - Cairo University
Cairo, Cairo Governorate, 11796
sayed M abed, MD, 01226806532, sydabed2020@outlook.com
sara F ali, MSc, +20 111588521, Sarafarghaly1234@gmail.com
About this study
Official title: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block Versus Erector Spinae Plane Block for Postoperative Pain Management After Modified Radical Mastectomy: A Randomized Clinical Trial
Breast cancer is the most common cancer affecting women worldwide. Modified radical mastectomy is one of the main surgical treatments for breast cancer. However, this surgery is often associated with significant postoperative pain, which may delay recovery and increase the need for opioid medications such as morphine.
Regional anesthesia techniques are increasingly used to improve pain control after breast surgery and reduce opioid consumption. The erector spinae plane block (ESPB) is a well-established ultrasound-guided technique that provides effective chest wall analgesia. The serratus posterior superior intercostal plane (SPSIP) block is a newer ultrasound-guided technique that targets intercostal nerves and may provide effective postoperative pain relief.
Read more
The purpose of this randomized clinical trial is to compare the effectiveness of SPSIP block versus ESPB block in controlling pain after modified radical mastectomy. The primary outcome will be total morphine consumption during the first 24 hours after surgery. Secondary outcomes include pain scores, time to first request for rescue analgesia, hemodynamic stability, recovery profile, patient satisfaction, and postoperative side effects such as nausea and vomiting.
This study aims to determine whether the newer SPSIP block provides comparable or superior pain control to ESPB, with the goal of improving postoperative recovery and reducing opioid requirements in breast cancer patients.
Read the detailed description
Breast cancer represents a major global health burden and remains one of the leading causes of cancer-related mortality among women. Modified radical mastectomy (MRM) is frequently performed as part of surgical management. Despite advances in perioperative care, postoperative pain following MRM remains significant due to extensive tissue dissection involving skin, muscles, and intercostal nerves.
Inadequate postoperative analgesia may result in delayed mobilization, increased opioid consumption, higher incidence of opioid-related adverse effects, prolonged hospital stay, and potential development of chronic post-mastectomy pain syndrome.
Ultrasound-guided fascial plane blocks have gained popularity as part of multimodal analgesia strategies in breast surgery. The erector spinae plane block (ESPB) involves injection of local anesthetic deep to the erector spinae muscle at the thoracic level, allowing spread to dorsal and ventral rami of spinal nerves. ESPB has demonstrated effectiveness in reducing postoperative pain scores and opioid consumption after breast surgery.
The serratus posterior superior intercostal plane (SPSIP) block is a recently described regional anesthesia technique. It involves ultrasound-guided injection of local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles, targeting the intercostal nerves. Preliminary reports suggest that SPSIP may provide effective thoracic analgesia with a favorable safety profile.
This prospective randomized clinical trial will include 50 female breast cancer patients undergoing modified radical mastectomy at the National Cancer Institute, Cairo University. Patients will be randomly assigned into two equal groups:
Group SPSIP: Ultrasound-guided serratus posterior superior intercostal plane block.
Group ESPB: Ultrasound-guided erector spinae plane block.
Both blocks will be performed preoperatively under ultrasound guidance using 20 mL of 0.25% bupivacaine. All patients will receive standardized general anesthesia and multimodal analgesia.
The primary outcome measure is total morphine consumption during the first 24 hours postoperatively.
Secondary outcomes include:
Visual Analog Scale (VAS) pain scores at rest and during movement at predefined time intervals (1, 3, 6, 12, 18, and 24 hours)
Time to first request for rescue analgesia
Hemodynamic parameters intraoperatively and postoperatively
Recovery time
Patient satisfaction
Incidence of adverse effects such as nausea and vomiting
The study hypothesis is that SPSIP block provides postoperative analgesia comparable or superior to ESPB in patients undergoing modified radical mastectomy.
The results of this study may contribute to optimizing regional anesthesia strategies for breast cancer surgery and support evidence-based, opioid-sparing perioperative pain management.
- Conditions
- Breast Cancer, Postoperative Pain, Acute Post-surgical Pain
- Being tested
- Serratus Posterior Superior Intercostal Plane Block, Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane Block, Modified Radical Mastectomy, Serratus Posterior Superior Intercostal Plane Block
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Ultrasound-guided serratus posterior superior intercostal plane block performed preoperatively. A 22G block needle is advanced in-plane under ultrasound guidance to the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. After negative aspiration, 20 mL of 0.25% bupivacaine is injected. The block is performed 30-45 minutes before surgery.
Erector Spinae Plane BlockProcedure or surgery
Ultrasound-guided erector spinae plane block performed preoperatively. A 22G needle is inserted in-plane to contact the transverse process at the T4-T5 level. After confirmation of correct placement and negative aspiration, 20 mL of 0.25% bupivacaine is injected deep to the erector spinae muscle. The block is performed 30-45 minutes before surgery.
| Study group | Role | What they receive |
|---|---|---|
| SPSIP Block Group | Experimental | Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. All participants will receive standardized general anesthesia and multimodal postoperative analgesia. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
| ESPB Block Group | Experimental | Participants will receive an ultrasound-guided erector spinae plane block (ESPB) before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be injected deep to the erector spinae muscle at the T4-T5 transverse process level. All participants will receive standardized general anesthesia and multimodal postoperative analgesia. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 24-Hour Postoperative Morphine Consumption
Total cumulative dose of intravenous morphine (in milligrams) administered during the first 24 hours after surgery as rescue analgesia. Morphine (3 mg IV) will be administered when the Visual Analogue Scale (VAS) score is ≥ 4. The total amount consumed over 24 hours will be recorded and compared between the two study groups.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block or ultrasound-guided erector spinae plane block (ESPB) prior to modified radical mastectomy. Both groups will receive standardized general anesthesia and multimodal analgesia. Outcomes will be compared between groups during the first 24 postoperative hours.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Mahmoud Abed, Cairo University
- Investigators
- Sayed M Abed, MD, Principal investigator, Associate Professor of Anesthesia and Pain Management, National Cancer Institute -- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446868
- Sponsor's protocol ID
- SPSIP-ESPB-MRM-2025
- Acronym
- SPSIP-ESPB
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality. Although all data will be anonymized, sharing individual-level data outside the research team is not permitted under the current Institutional Review Board (IRB) approval. Aggregated results will be available through publication and may be provided upon reasonable request to the corresponding author, in accordance with institutional regulations.
Publications
Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
PubMed 36883093Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block Versus Erector Spinae Plane Block for Postoperative Pain Management After Modified Radical Mastectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07446868
- Acronym / sponsor ID
- SPSIP-ESPB / SPSIP-ESPB-MRM-2025
- Conditions
- Breast Cancer, Postoperative Pain, Acute Post-surgical Pain
- Keywords
- Erector Spinae Plane Block, Modified Radical Mastectomy, Serratus Posterior Superior Intercostal Plane Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 3 Mar 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.
Breast cancer is the most common cancer affecting women worldwide. Modified radical mastectomy is one of the main surgical treatments for breast cancer. However, this surgery is often associated with significant postoperative pain, which may delay recovery and increase the need for opioid medications such as morphine.
Regional anesthesia techniques are increasingly used to improve pain control after breast surgery and reduce opioid consumption. The erector spinae plane block (ESPB) is a well-established ultrasound-guided technique that provides effective chest wall analgesia. The serratus posterior superior intercostal plane (SPSIP) block is a newer ultrasound-guided technique that targets intercostal nerves and may provide effective postoperative pain relief.
The purpose of this randomized clinical trial is to compare the effectiveness of SPSIP block versus ESPB block in controlling pain after modified radical mastectomy. The primary outcome will be total morphine consumption during the first 24 hours after surgery. Secondary outcomes include pain scores, time to first request for rescue analgesia, hemodynamic stability, recovery profile, patient satisfaction, and postoperative side effects such as nausea and vomiting.
This study aims to determine whether the newer SPSIP block provides comparable or superior pain control to ESPB, with the goal of improving postoperative recovery and reducing opioid requirements in breast cancer patients.
Detailed description
Breast cancer represents a major global health burden and remains one of the leading causes of cancer-related mortality among women. Modified radical mastectomy (MRM) is frequently performed as part of surgical management. Despite advances in perioperative care, postoperative pain following MRM remains significant due to extensive tissue dissection involving skin, muscles, and intercostal nerves.
Inadequate postoperative analgesia may result in delayed mobilization, increased opioid consumption, higher incidence of opioid-related adverse effects, prolonged hospital stay, and potential development of chronic post-mastectomy pain syndrome.
Ultrasound-guided fascial plane blocks have gained popularity as part of multimodal analgesia strategies in breast surgery. The erector spinae plane block (ESPB) involves injection of local anesthetic deep to the erector spinae muscle at the thoracic level, allowing spread to dorsal and ventral rami of spinal nerves. ESPB has demonstrated effectiveness in reducing postoperative pain scores and opioid consumption after breast surgery.
The serratus posterior superior intercostal plane (SPSIP) block is a recently described regional anesthesia technique. It involves ultrasound-guided injection of local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles, targeting the intercostal nerves. Preliminary reports suggest that SPSIP may provide effective thoracic analgesia with a favorable safety profile.
This prospective randomized clinical trial will include 50 female breast cancer patients undergoing modified radical mastectomy at the National Cancer Institute, Cairo University. Patients will be randomly assigned into two equal groups:
Group SPSIP: Ultrasound-guided serratus posterior superior intercostal plane block.
Group ESPB: Ultrasound-guided erector spinae plane block.
Both blocks will be performed preoperatively under ultrasound guidance using 20 mL of 0.25% bupivacaine. All patients will receive standardized general anesthesia and multimodal analgesia.
The primary outcome measure is total morphine consumption during the first 24 hours postoperatively.
Secondary outcomes include:
Visual Analog Scale (VAS) pain scores at rest and during movement at predefined time intervals (1, 3, 6, 12, 18, and 24 hours)
Time to first request for rescue analgesia
Hemodynamic parameters intraoperatively and postoperatively
Recovery time
Patient satisfaction
Incidence of adverse effects such as nausea and vomiting
The study hypothesis is that SPSIP block provides postoperative analgesia comparable or superior to ESPB in patients undergoing modified radical mastectomy.
The results of this study may contribute to optimizing regional anesthesia strategies for breast cancer surgery and support evidence-based, opioid-sparing perioperative pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block or ultrasound-guided erector spinae plane block (ESPB) prior to modified radical mastectomy. Both groups will receive standardized general anesthesia and multimodal analgesia. Outcomes will be compared between groups during the first 24 postoperative hours.
| Arm | Type | Receives |
|---|---|---|
| SPSIP Block Group | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane BlockParticipants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. All participants will receive standardized general anesthesia and multimodal postoperative analgesia. |
| ESPB Block Group | Experimental | Procedure: Erector Spinae Plane BlockParticipants will receive an ultrasound-guided erector spinae plane block (ESPB) before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be injected deep to the erector spinae muscle at the T4-T5 transverse process level. All participants will receive standardized general anesthesia and multimodal postoperative analgesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients diagnosed with breast cancer
- Scheduled for modified radical mastectomy (MRM)
- American Society of Anesthesiologists (ASA) physical status II or III
- Age 18-65 years
- Body mass index (BMI) > 20 kg/m² and < 35 kg/m²
Key exclusion criteria (8 listed)
- Patient refusal to participate
- ASA physical status IV or higher
- BMI ≤ 20 kg/m² or ≥ 35 kg/m²
- Known hypersensitivity or contraindication to local anesthetics, opioids, or study medications
- History of chronic pain or regular 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 |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane BlockUltrasound-guided serratus posterior superior intercostal plane block performed preoperatively. A 22G block needle is advanced in-plane under ultrasound guidance to the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. After negative aspiration, 20 mL of 0.25% bupivacaine is injected. The block is performed 30-45 minutes before surgery. | Procedure or surgery | SPSIP Block Group |
| Erector Spinae Plane BlockUltrasound-guided erector spinae plane block performed preoperatively. A 22G needle is inserted in-plane to contact the transverse process at the T4-T5 level. After confirmation of correct placement and negative aspiration, 20 mL of 0.25% bupivacaine is injected deep to the erector spinae muscle. The block is performed 30-45 minutes before surgery. | Procedure or surgery | ESPB Block Group |
Primary outcome
Total 24-Hour Postoperative Morphine Consumption
Time frame: First 24 hours postoperatively
Total cumulative dose of intravenous morphine (in milligrams) administered during the first 24 hours after surgery as rescue analgesia. Morphine (3 mg IV) will be administered when the Visual Analogue Scale (VAS) score is ≥ 4. The total amount consumed over 24 hours will be recorded and compared between the two study groups.
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 1 Sep 2026.
- Results publication: PubMed 36883093Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Results publication: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality. Although all data will be anonymized, sharing individual-level data outside the research team is not permitted under the current Institutional Review Board (IRB) approval. Aggregated results will be available through publication and may be provided upon reasonable request to the corresponding author, in accordance with institutional regulations.
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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.
Sayed M Abed, MD principal investigator
Associate Professor of Anesthesia and Pain Management, National Cancer Institute -- Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block in people with Breast Cancer and Postoperative Pain, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 8 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 1 Sep 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 Egypt. 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 Sayed M Abed, MD (+20 122 680 6532, sayed.abed@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 24-Hour Postoperative Morphine Consumption (time frame: First 24 hours postoperatively). 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 NCT07446868, 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 1 Sep 2026.