Acute Pancreatitis (AP)NCT06998784
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Acute Pancreatitis
A study testing taVNS in people with Acute Pancreatitis (AP) and Vagus Nerve Stimulations, run by Air Force Military Medical University, China at 5 sites in China.
Trial summary
Acute pancreatitis (AP), characterized by the sudden onset of pancreatic inflammation, is a frequent gastrointestinal emergency. Early suppression of the inflammatory response is critical to mitigate disease progression. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pancreatitis (AP), Vagus Nerve Stimulations
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesChina
- Study dates
- 15 May 2025to 1 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AP patients aged 18-80 years.
- PAN-PROMISE score ≥15 and no participation in any other clinical trials within the past 3 months.
- AP patients who presented to the emergency department no more than 24 hours after symptom onset and who had received a diagnosis no more than 8 hours before enrollment.
Who cannot join
- Patients with an APACHE II score≥8, a C-reactive protein (CRP) level > 150 mg/L, or organ failure at baseline (shock, respiratory failure, or renal failure) were excluded.
- Presence of diseases or conditions different from AP that may interfere with the scale, for example, other causes of abdominal pain (especially acute cholecystitis), obstruction of the digestive tract (peptic pyloric stenosis, gastrointestinal anastomotic stenosis, diabetic gastroparesis, gastrointestinal neoplasia...), nausea-vomiting (brain tumour, chemotherapy...) or weakness (pre-existing anaemia with haemoglobin <9 g/dL, heart failure or respiratory insufficiency associated with minimal effort dyspnoea, or domiciliary treatment with O2, advanced neoplasms or other debilitating diseases);
- Implanted cardiac pacemaker or other electronic devices;
- Prior treatment with transcutaneous auricular vagus nerve stimulation (taVNS);
- Known malignancy;
- Severe cardiovascular/cerebrovascular, hepatic, or renal diseases;
- Cognitive impairment, psychiatric disorders, or other conditions that may affect patient cooperation;
- Refusal to sign informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The 980th Hospital of the PLA Joint Logistics Support Force (Primary Bethune International Peace Hospital of PLA)
Shijiazhuang, Hebei, 050082
Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710000
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Department of Gastroenterology , Tangdu Hospital , Fourth Military Medical University
Xi'an, Shaanxi, 710038
Department of Gastroenterology, 986 Hospital of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710054
About this study
Official title: Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Acute Pancreatitis: A Randomized Controlled Trial
Acute pancreatitis (AP), characterized by the sudden onset of pancreatic inflammation, is a frequent gastrointestinal emergency. Early suppression of the inflammatory response is critical to mitigate disease progression. When localized pancreatic inflammation progresses to systemic inflammation, triggering systemic inflammatory response syndrome (SIRS), the condition advances to moderate or severe AP, with mortality rates ranging from 10% to 40%. Additionally, early resumption of enteral nutrition reduces the risk of intra-abdominal infections and organ failure associated with AP. However, gastrointestinal dysfunction, which frequently manifests as gastroparesis or intestinal obstruction in severe cases , significantly complicates AP management by prolonging recovery time and compromising nutritional tolerance. Current early-phase management of AP remains suboptimal: anti-inflammatory strategies are predominantly limited to fluid resuscitation, while gastrointestinal function preservation is frequently underestimated. Consequently, effective therapies targeting both inflammatory suppression and gastrointestinal functional restoration in the early phase of AP are urgently needed.
The central nervous system plays a pivotal role in regulating peripheral immune responses, with the vagal anti-inflammatory signaling pathway serving as a key efferent pathway of the inflammatory reflex. Animal studies have shown a protective effect of the vagal anti-inflammatory signaling pathway against AP. Specifically, vagus nerve stimulation (VNS) significantly reduced pancreatic injury and improved survival in mice with severe AP. Furthermore, VNS has shown therapeutic potential in animal models of sepsis, shock, and renal ischemia-reperfusion injury, conditions frequently associated with systemic inflammation in severe pancreatitis. These findings suggest that VNS may alleviate both local and systemic inflammatory responses, as well as their complications.
Notably, prior clinical trial revealed that transcutaneous auricular VNS (taVNS) alleviated functional dyspepsia symptoms in adults, indicating its dual capacity for anti-inflammatory effects and gastrointestinal functional modulation. Based on this evidence, the investigators propose a randomized, sham-controlled trial to systematically evaluate the therapeutic efficacy of taVNS in patients with acute pancreatitis .
- Conditions
- Acute Pancreatitis (AP), Vagus Nerve Stimulations
- Being tested
- taVNS, Sham-taVNS
- Keywords
- acute pancreatitis, vagus nerve stimulations, PAN-PROMISE
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Patients will receive taVNS at left tragus (a device developed by the Engineering Research Center of Molecular and Neuro Imaging, Ministry of Education (School of Life Science and Technology, Xidian University), in collaboration with the Wearable BCI and Intelligent Rehabilitation Innovation Lab (Guangzhou Institute of Technology, Xidian University)) twice daily (morning and night) for 30 minutes per session over a period of up to 7 days. The stimulation parameters are as follows:
- Duty circle: 30s "on" periods alternating with 30s "off" periods;
- Frequency: 25 Hz;
- Amplitude: 0-2 mA (adjusted to the maximum tolerated level for each patient);
- Pulse width: 0.5 ms.
Sham-taVNSDevice
Patients will receive taVNS at left earlobe (a device developed by the Engineering Research Center of Molecular and Neuro Imaging, Ministry of Education (School of Life Science and Technology, Xidian University), in collaboration with the Wearable BCI and Intelligent Rehabilitation Innovation Lab (Guangzhou Institute of Technology, Xidian University)) twice daily (morning and night) for 30 minutes per session over a period of up to 7 days. The stimulation parameters are as follows: *Duty circle: 30s "on" periods alternating with 30s "off" periods; *Frequency: 25 Hz; *Amplitude: 0-2 mA (adjusted to the maximum tolerated level for each patient); *Pulse width: 0.5 ms.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients will receive taVNS at left tragus up to 7 days. Receives: Device: taVNS |
| Sham-treatment group | Sham comparator | Patients will receive sham-taVNS at left earlobe up to 7 days. Receives: Device: Sham-taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median treatment duration
The number of treatment days required to reduce the PAN-PROMISE scores to 6. The PAN-PROMISE score (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis from an international proSpEctive cohort study) consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. Each symptom is rated on a scale of 0 to 10 points, where higher scores reflect greater symptom severity.
Measured: Up to one week
Secondary outcomes (4)
PAN-PROMISE score during the study period
Change from baseline in PAN-PROMISE score during the study period.The PAN-PROMISE score (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis from an international proSpEctive cohort study) consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. Each symptom is rated on a scale of 0 to 10 points, where higher scores reflect greater symptom severity.
Measured: 1 week
Responder rate
Proportion of patients with PAN-PROMISE score reduced to 6. The PAN-PROMISE score (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis from an international proSpEctive cohort study) consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. Each symptom is rated on a scale of 0 to 10 points, where higher scores reflect greater symptom severity.
Measured: 1 week
Biochemical Profiles
Mean serum IL-6 concentration at treatment days 3
Measured: at treatment days 3
Median time from AP onset to enteral nutrition resumption
Enteral nutrition (EN) resumption refers to nutritional intake via oral or jejunal tube routes following gastrointestinal functional recovery.
Measured: an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start15 May 2025
- Primary completion20 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Pancreatitis (AP)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998784
- Sponsor's protocol ID
- KY20242424
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers can contact PI to get IPD.
Publications
Shi X, Zhao L, Luo H, Deng H, Wang X, Ren G, Zhang L, Tao Q, Liang S, Liu N, Huang X, Zhang X, Yang X, Sun J, Qin W, Kang X, Han Y, Pan Y, Fan D. Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Am J Gastroenterol. 2024 Mar 1;119(3):521-531. doi: 10.14309/ajg.0000000000002548. Epub 2023 Oct 3.
PubMed 37787432Inoue T, Abe C, Sung SS, Moscalu S, Jankowski J, Huang L, Ye H, Rosin DL, Guyenet PG, Okusa MD. Vagus nerve stimulation mediates protection from kidney ischemia-reperfusion injury through alpha7nAChR+ splenocytes. J Clin Invest. 2016 May 2;126(5):1939-52. doi: 10.1172/JCI83658. Epub 2016 Apr 18.
PubMed 27088805Morishita K, Costantini TW, Eliceiri B, Bansal V, Coimbra R. Vagal nerve stimulation modulates the dendritic cell profile in posthemorrhagic shock mesenteric lymph. J Trauma Acute Care Surg. 2014 Mar;76(3):610-7; discussion 617-8. doi: 10.1097/TA.0000000000000137.
PubMed 24553526Kelly MJ, Breathnach C, Tracey KJ, Donnelly SC. Manipulation of the inflammatory reflex as a therapeutic strategy. Cell Rep Med. 2022 Jul 19;3(7):100696. doi: 10.1016/j.xcrm.2022.100696.
PubMed 35858588Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA. 2021 Jan 26;325(4):382-390. doi: 10.1001/jama.2020.20317.
PubMed 33496779Xie J, Cai Y, Xu H, Peng Y, McArthur A. Early enteral nutrition support for patients with acute pancreatitis in the inpatient setting: a best practice implementation project. JBI Evid Implement. 2024 May 1;22(2):175-185. doi: 10.1097/XEB.0000000000000410.
PubMed 38415812Lee PJ, Papachristou GI. New insights into acute pancreatitis. Nat Rev Gastroenterol Hepatol. 2019 Aug;16(8):479-496. doi: 10.1038/s41575-019-0158-2.
PubMed 31138897Feng J, Chen L, Lou L, Liu T, Zhang C, Xu S, Liu J, Wang L, Wang J, Liu Z, Jin H, Li J, Luo H, Pan Y. Transcutaneous Auricular Vagal Nerve Stimulation Alleviates Symptoms of Mild Acute Pancreatitis: A Multicenter Randomized Double-Blind Sham-Controlled Study. Am J Gastroenterol. 2026 May 19. doi: 10.14309/ajg.0000000000004060. Online ahead of print.
PubMed 42153655
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Acute Pancreatitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06998784
- Acronym / sponsor ID
- KY20242424
- Conditions
- Acute Pancreatitis (AP), Vagus Nerve Stimulations
- Keywords
- acute pancreatitis, vagus nerve stimulations, PAN-PROMISE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 31 May 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.
Acute pancreatitis (AP), characterized by the sudden onset of pancreatic inflammation, is a frequent gastrointestinal emergency. Early suppression of the inflammatory response is critical to mitigate disease progression. When localized pancreatic inflammation progresses to systemic inflammation, triggering systemic inflammatory response syndrome (SIRS), the condition advances to moderate or severe AP, with mortality rates ranging from 10% to 40%. Additionally, early resumption of enteral nutrition reduces the risk of intra-abdominal infections and organ failure associated with AP. However, gastrointestinal dysfunction, which frequently manifests as gastroparesis or intestinal obstruction in severe cases , significantly complicates AP management by prolonging recovery time and compromising nutritional tolerance. Current early-phase management of AP remains suboptimal: anti-inflammatory strategies are predominantly limited to fluid resuscitation, while gastrointestinal function preservation is frequently underestimated. Consequently, effective therapies targeting both inflammatory suppression and gastrointestinal functional restoration in the early phase of AP are urgently needed.
The central nervous system plays a pivotal role in regulating peripheral immune responses, with the vagal anti-inflammatory signaling pathway serving as a key efferent pathway of the inflammatory reflex. Animal studies have shown a protective effect of the vagal anti-inflammatory signaling pathway against AP. Specifically, vagus nerve stimulation (VNS) significantly reduced pancreatic injury and improved survival in mice with severe AP. Furthermore, VNS has shown therapeutic potential in animal models of sepsis, shock, and renal ischemia-reperfusion injury, conditions frequently associated with systemic inflammation in severe pancreatitis. These findings suggest that VNS may alleviate both local and systemic inflammatory responses, as well as their complications.
Notably, prior clinical trial revealed that transcutaneous auricular VNS (taVNS) alleviated functional dyspepsia symptoms in adults, indicating its dual capacity for anti-inflammatory effects and gastrointestinal functional modulation. Based on this evidence, the investigators propose a randomized, sham-controlled trial to systematically evaluate the therapeutic efficacy of taVNS in patients with acute pancreatitis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: taVNSPatients will receive taVNS at left tragus up to 7 days. |
| Sham-treatment group | Sham comparator | Device: Sham-taVNSPatients will receive sham-taVNS at left earlobe up to 7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AP patients aged 18-80 years.
- PAN-PROMISE score ≥15 and no participation in any other clinical trials within the past 3 months.
- AP patients who presented to the emergency department no more than 24 hours after symptom onset and who had received a diagnosis no more than 8 hours before enrollment.
Key exclusion criteria (8 listed)
- Patients with an APACHE II score≥8, a C-reactive protein (CRP) level > 150 mg/L, or organ failure at baseline (shock, respiratory failure, or renal failure) were excluded.
- Presence of diseases or conditions different from AP that may interfere with the scale, for example, other causes of abdominal pain (especially acute cholecystitis), obstruction of the digestive tract (peptic pyloric stenosis, gastrointestinal anastomotic stenosis, diabetic gastroparesis, gastrointestinal neoplasia...), nausea-vomiting (brain tumour, chemotherapy...) or weakness (pre-existing anaemia with haemoglobin <9 g/dL, heart failure or respiratory insufficiency associated with minimal effort dyspnoea, or domiciliary treatment with O2, advanced neoplasms or other debilitating diseases);
- Implanted cardiac pacemaker or other electronic devices;
- Prior treatment with transcutaneous auricular vagus nerve stimulation (taVNS);
- Known malignancy;
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 |
|---|---|---|
| taVNSPatients will receive taVNS at left tragus (a device developed by the Engineering Research Center of Molecular and Neuro Imaging, Ministry of Education (School of Life Science and Technology, Xidian University), in collaboration with the Wearable BCI and Intelligent Rehabilitation Innovation Lab (Guangzhou Institute of Technology, Xidian University)) twice daily (morning and night) for 30 minutes per session over a period of up to 7 days. The stimulation parameters are as follows: * Duty circle: 30s "on" periods alternating with 30s "off" periods; * Frequency: 25 Hz; * Amplitude: 0-2 mA (adjusted to the maximum tolerated level for each patient); * Pulse width: 0.5 ms. | Device | Treatment group |
| Sham-taVNSPatients will receive taVNS at left earlobe (a device developed by the Engineering Research Center of Molecular and Neuro Imaging, Ministry of Education (School of Life Science and Technology, Xidian University), in collaboration with the Wearable BCI and Intelligent Rehabilitation Innovation Lab (Guangzhou Institute of Technology, Xidian University)) twice daily (morning and night) for 30 minutes per session over a period of up to 7 days. The stimulation parameters are as follows: *Duty circle: 30s "on" periods alternating with 30s "off" periods; *Frequency: 25 Hz; *Amplitude: 0-2 mA (adjusted to the maximum tolerated level for each patient); *Pulse width: 0.5 ms. | Device | Sham-treatment group |
Primary outcome
Median treatment duration
Time frame: Up to one week
The number of treatment days required to reduce the PAN-PROMISE scores to 6. The PAN-PROMISE score (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis from an international proSpEctive cohort study) consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. Each symptom is rated on a scale of 0 to 10 points, where higher scores reflect greater symptom severity.
4 secondary outcomes
PAN-PROMISE score during the study period
Time frame: 1 week
Responder rate
Time frame: 1 week
Biochemical Profiles
Time frame: at treatment days 3
Median time from AP onset to enteral nutrition resumption
Time frame: an average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 37787432Shi X, Zhao L, Luo H, Deng H, Wang X, Ren G, Zhang L, Tao Q, Liang S, Liu N, Huang X, Zhang X, Yang X, Sun J, Qin W, Kang X, Han Y, Pan Y, Fan D. Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Am J Gastroenterol. 2024 Mar 1;119(3):521-531. doi: 10.14309/ajg.0000000000002548. Epub 2023 Oct 3.
- Background: PubMed 27088805Inoue T, Abe C, Sung SS, Moscalu S, Jankowski J, Huang L, Ye H, Rosin DL, Guyenet PG, Okusa MD. Vagus nerve stimulation mediates protection from kidney ischemia-reperfusion injury through alpha7nAChR+ splenocytes. J Clin Invest. 2016 May 2;126(5):1939-52. doi: 10.1172/JCI83658. Epub 2016 Apr 18.
- Background: PubMed 24553526Morishita K, Costantini TW, Eliceiri B, Bansal V, Coimbra R. Vagal nerve stimulation modulates the dendritic cell profile in posthemorrhagic shock mesenteric lymph. J Trauma Acute Care Surg. 2014 Mar;76(3):610-7; discussion 617-8. doi: 10.1097/TA.0000000000000137.
- Background: PubMed 35858588Kelly MJ, Breathnach C, Tracey KJ, Donnelly SC. Manipulation of the inflammatory reflex as a therapeutic strategy. Cell Rep Med. 2022 Jul 19;3(7):100696. doi: 10.1016/j.xcrm.2022.100696.
- Background: PubMed 33496779Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA. 2021 Jan 26;325(4):382-390. doi: 10.1001/jama.2020.20317.
- Background: PubMed 38415812Xie J, Cai Y, Xu H, Peng Y, McArthur A. Early enteral nutrition support for patients with acute pancreatitis in the inpatient setting: a best practice implementation project. JBI Evid Implement. 2024 May 1;22(2):175-185. doi: 10.1097/XEB.0000000000000410.
- Background: PubMed 31138897Lee PJ, Papachristou GI. New insights into acute pancreatitis. Nat Rev Gastroenterol Hepatol. 2019 Aug;16(8):479-496. doi: 10.1038/s41575-019-0158-2.
- Derived from this study: PubMed 42153655Feng J, Chen L, Lou L, Liu T, Zhang C, Xu S, Liu J, Wang L, Wang J, Liu Z, Jin H, Li J, Luo H, Pan Y. Transcutaneous Auricular Vagal Nerve Stimulation Alleviates Symptoms of Mild Acute Pancreatitis: A Multicenter Randomized Double-Blind Sham-Controlled Study. Am J Gastroenterol. 2026 May 19. doi: 10.14309/ajg.0000000000004060. Online ahead of print.
- Individual participant dataSharing planned: No. Other researchers can contact PI to get IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with Acute Pancreatitis (AP) and Vagus Nerve Stimulations, run by Air Force Military Medical University, China at 5 sites 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 3 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: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median treatment duration (time frame: Up to one week). 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 NCT06998784, which also lists 8 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 31 Mar 2026.