Incisional Ventral HerniaNCT07422584
Cytokine Response to Abdominal Wall Reconstruction
An observational study of Incisional Ventral Hernia, run by Northwestern University at 1 site in United States.
Trial summary
This is a prospective, observational translational study of patients undergoing major abdominal wall reconstruction with primary fascial closure. The project integrates perioperative cytokine profiling, direct measurement of intra-abdominal pressure, and detailed clinical outcomes to define the biologic and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Ventral Hernia
- What is being tested?
- Not applicable- observational study
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2026to 5 Mar 2027
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will include adult patients undergoing elective major abdominal wall reconstruction at Northwestern Memorial Hospital. Patients with large ventral hernias requiring component separation and anticipated primary fascial closure will be eligible.
Who may be able to join
- Surgical Participants
- Adults aged 18 years or older
- Scheduled to undergo open retromuscular ventral hernia repair
- Able to provide written informed consent Healthy Control Participants
- Adults aged 18 years or older
- No known inflammatory, autoimmune, or immunologic disease
- Able to provide written informed consent
Who cannot join
- Emergent or urgent cases
- Pregnancy
- Chronic systemic steroid use or immunosuppressive therapy
- Active infection at the time of enrollment
- Known autoimmune or inflammatory disease
- End-stage organ failure
- Abdominal surgery within the preceding 60 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Megan Melland-Smith, MD, 312-907-1414, megan.mellandsmith@nm.org
Nancy Ly, MD, 262-455-1560, nancy.ly@nm.org
About this study
Official title: Pilot Study of Systemic Inflammatory and Transcriptomic Responses in Patients Undergoing Open Retromuscular Ventral Hernia Repair
This is a prospective, observational translational study of patients undergoing major abdominal wall reconstruction with primary fascial closure. The project integrates perioperative cytokine profiling, direct measurement of intra-abdominal pressure, and detailed clinical outcomes to define the biologic and physiologic consequences of high-tension closure.
The study includes three cohorts: 1) Healthy controls (N=5), 2) High-tension fascial closure AWR patients (N=10), 3) Low-tension fascial closure AWR patients (N=10). Fascial closure tension will not be altered for the purpose of the study and will be determined by the operating surgeon as part of routine clinical decision-making.
Read the detailed description
Major abdominal wall reconstruction (AWR) for large ventral hernias is among the most physiologically demanding procedures performed in general surgery. These patients often have a history of multiple prior abdominal operations, chronically altered abdominal wall mechanics and significant loss of domain. Reduction of visceral contents and abdominal wall reconstruction frequently require high-tension closure, resulting in an abrupt increase in intra-abdominal pressure (IAP) that impairs diaphragmatic excursion, reduces splanchnic perfusion, causes renal venous congestion and induces global physiologic stress. Consequently, these patients face a high risk of postoperative complications including respiratory failure, renal dysfunction, and prolonged intensive care unit (ICU) stays.
A critical gap in AWR research is the lack of characterization of the biologic inflammatory and cytokine responses associated with high-tension abdominal wall closure. This gap stands in contrast to robust evidence from the trauma and critical care literature demonstrating that cytokine activation correlates with injury severity and contributes to organ dysfunction and postoperative morbidity.
Defining the inflammatory and cytokine signaling pathways activated during high-tension closure would provide a framework to inform operative planning and perioperative management, particularly in patients with significant comorbidities who may be less tolerant to postoperative physiologic stress. These insights would enable validation of current techniques and establish the foundation for future interventional trials targeting inflammatory pathways to improve postoperative outcomes. The Digestive Health Institute at Northwestern University is uniquely positioned to support this translational research, bridging surgical physiology, inflammation, and patient outcomes.
The investigators hypothesize that:
- Major abdominal wall reconstruction induces a trauma-like systemic inflammatory response characterized by elevations in GM-CSF, IFN-Gamma, IL-1, IL-2, IL-5, IL-6, IL-8, and TNF-alpha with a concomitant decrease in the anti-inflammatory cytokines, IL-4 and IL-10.
- Increased intra-abdominal pressure (IAP) following high-tension closure amplifies cytokine activation and is associated with early postoperative organ dysfunction and increased postoperative complications.
- Conditions
- Incisional Ventral Hernia
- Being tested
- Not applicable- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
There are no interventions in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| High tension group | Massive incisional ventral hernias with loss of domain undergoing open ventral hernia repair with transversus abdominis release with placement of mesh and closure of fascia under high tension. Receives: Other: Not applicable- observational study | |
| Low tension group | Incisional ventral hernias undergoing open ventral hernia repair with transversus abdominis release with placement of mesh and closure of fascia under low tension. Receives: Other: Not applicable- observational study | |
| Control | Healthy human subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether fascial closure tension correlates with systemic and peritoneal fluid cytokine activation.
Blood and peritoneal fluid will be collected at baseline (intra-operative), immediately following fascial closure and on postoperative days 1, 3, and 5. Serum cytokine concentrations of GM-CSF, IFN-gamma, IL-1, IL-2, IL-5, IL-6, IL-8, and TNF-alpha (inflammatory); IL-4 and IL-10 (anti-inflammatory) will be measured via multiplex immunoassays (Luminex). Cytokine area under the curve will also be calculated to allow analysis of total cytokine exposure over time.
Measured: Baseline through postoperative day 5
Secondary outcomes (9)
Differences in peripheral blood mononuclear cells and peritoneal macrophage transcriptomic signatures via bulk RNA sequencing between baseline profiles from healthy control subjects, high-tension and low-tension abdominal wall closures.
Peripheral blood mononuclear cells (PBMCs) and peritoneal macrophages will be isolated at baseline, immediately following fascial closure and on postoperative days 1, 3, and 5. Bulk RNA sequencing will be performed. Differentially expressed genes will be determined and KEGG and GO pathway analyses performed.
Measured: Baseline through postoperative day 5
Differences in peak intra-abdominal values, intra-abdominal hypertension grading, abdominal perfusion pressure, plateau pressure between baseline profiles from healthy control subjects, high-tension and low-tension abdominal wall closures.
Intra-abdominal pressure (IAP) will be assessed using bladder pressure measurements, along with plateau pressure and abdominal perfusion pressure (APP) - calculated as mean arterial pressure (MAP) minus IAP. Measurements will be obtained at baseline, POD1, POD3 and POD5. Measures will include peak IAP, and duration of intra-abdominal hypertension (IAH), defined as IAP >12mmHg. Peak serum cytokine levels will be correlated with peak IAP using Spearman correlation and multivariable linear regression.
Measured: Baseline through postoperative day 5
Incidence of respiratory compromise
Respiratory compromise defined as failure to wean from mechanical ventilation or development of postoperative pneumonia.
Measured: From surgery through hospital discharge (up to 30 days)
Incidence of acute kidney injury
Acute kidney injury defined as increase in serum creatinine to >1.5 times baseline with urine output <0.5 mL/kg/hr for 6 hours.
Measured: From surgery through hospital discharge (up to 30 days)
Incidence of vasopressor use
Requirement for vasopressor support postoperatively.
Measured: From surgery through hospital discharge (up to 30 days)
Incidence of postoperative ileus
Development of postoperative ileus as documented in the medical record.
Measured: From surgery through hospital discharge (up to 30 days)
Incidence of wound complications
Development of surgical site infection or wound dehiscence
Measured: From surgery through hospital discharge (up to 30 days)
ICU length of stay
Number of days in the intensive care unit following surgery.
Measured: From surgery through hospital discharge (up to 30 days)
Hospital length of stay
Total number of days hospitalized following surgery.
Measured: From surgery through hospital discharge (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start3 Feb 2026
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Mar 2027 (estimated)
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 Incisional Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Melland-Smith, Northwestern University
- Investigators
- Michael Rosen, MD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422584
- Sponsor's protocol ID
- STU00225446
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to researchers not involved in specimen processing, data collection or analysis.
Publications
Rettig TC, Verwijmeren L, Dijkstra IM, Boerma D, van de Garde EM, Noordzij PG. Postoperative Interleukin-6 Level and Early Detection of Complications After Elective Major Abdominal Surgery. Ann Surg. 2016 Jun;263(6):1207-12. doi: 10.1097/SLA.0000000000001342.
PubMed 26135695Dimopoulou I, Armaganidis A, Douka E, Mavrou I, Augustatou C, Kopterides P, Lyberopoulos P, Tzanela M, Orfanos SE, Pelekanou E, Kostopanagiotou G, Macheras A, Giamarellos-Bourboulis EJ. Tumour necrosis factor-alpha (TNFalpha) and interleukin-10 are crucial mediators in post-operative systemic inflammatory response and determine the occurrence of complications after major abdominal surgery. Cytokine. 2007 Jan;37(1):55-61. doi: 10.1016/j.cyto.2007.02.023. Epub 2007 Apr 10.
PubMed 17428673Jansson K, Redler B, Truedsson L, Magnuson A, Matthiessen P, Andersson M, Norgren L. Intraperitoneal cytokine response after major surgery: higher postoperative intraperitoneal versus systemic cytokine levels suggest the gastrointestinal tract as the major source of the postoperative inflammatory reaction. Am J Surg. 2004 Mar;187(3):372-7. doi: 10.1016/j.amjsurg.2003.12.019.
PubMed 15006565Badia JM, Whawell SA, Scott-Coombes DM, Abel PD, Williamson RC, Thompson JN. Peritoneal and systemic cytokine response to laparotomy. Br J Surg. 1996 Mar;83(3):347-8. doi: 10.1002/bjs.1800830316. No abstract available.
PubMed 8665188Sido B, Teklote JR, Hartel M, Friess H, Buchler MW. Inflammatory response after abdominal surgery. Best Pract Res Clin Anaesthesiol. 2004 Sep;18(3):439-54. doi: 10.1016/j.bpa.2003.12.006.
PubMed 15212338Li R, Ye JJ, Gan L, Zhang M, Sun D, Li Y, Wang T, Chang P. Traumatic inflammatory response: pathophysiological role and clinical value of cytokines. Eur J Trauma Emerg Surg. 2024 Aug;50(4):1313-1330. doi: 10.1007/s00068-023-02388-5. Epub 2023 Dec 27.
PubMed 38151578Blatnik JA, Krpata DM, Pesa NL, Will P, Harth KC, Novitsky YW, Rowbottom JR, Rosen MJ. Predicting severe postoperative respiratory complications following abdominal wall reconstruction. Plast Reconstr Surg. 2012 Oct;130(4):836-841. doi: 10.1097/PRS.0b013e318262f160.
PubMed 22691844Petro CC, Raigani S, Fayezizadeh M, Rowbottom JR, Klick JC, Prabhu AS, Novitsky YW, Rosen MJ. Permissible Intraabdominal Hypertension following Complex Abdominal Wall Reconstruction. Plast Reconstr Surg. 2015 Oct;136(4):868-881. doi: 10.1097/PRS.0000000000001621.
PubMed 26090761
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Systemic Inflammatory and Transcriptomic Responses in Patients Undergoing Open Retromuscular Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT07422584
- Acronym / sponsor ID
- STU00225446
- Conditions
- Incisional Ventral Hernia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Mar 2027 (estimated)
- First posted
- 20 Feb 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 is a prospective, observational translational study of patients undergoing major abdominal wall reconstruction with primary fascial closure. The project integrates perioperative cytokine profiling, direct measurement of intra-abdominal pressure, and detailed clinical outcomes to define the biologic and physiologic consequences of high-tension closure.
The study includes three cohorts: 1) Healthy controls (N=5), 2) High-tension fascial closure AWR patients (N=10), 3) Low-tension fascial closure AWR patients (N=10). Fascial closure tension will not be altered for the purpose of the study and will be determined by the operating surgeon as part of routine clinical decision-making.
Detailed description
Major abdominal wall reconstruction (AWR) for large ventral hernias is among the most physiologically demanding procedures performed in general surgery. These patients often have a history of multiple prior abdominal operations, chronically altered abdominal wall mechanics and significant loss of domain. Reduction of visceral contents and abdominal wall reconstruction frequently require high-tension closure, resulting in an abrupt increase in intra-abdominal pressure (IAP) that impairs diaphragmatic excursion, reduces splanchnic perfusion, causes renal venous congestion and induces global physiologic stress. Consequently, these patients face a high risk of postoperative complications including respiratory failure, renal dysfunction, and prolonged intensive care unit (ICU) stays.
A critical gap in AWR research is the lack of characterization of the biologic inflammatory and cytokine responses associated with high-tension abdominal wall closure. This gap stands in contrast to robust evidence from the trauma and critical care literature demonstrating that cytokine activation correlates with injury severity and contributes to organ dysfunction and postoperative morbidity.
Defining the inflammatory and cytokine signaling pathways activated during high-tension closure would provide a framework to inform operative planning and perioperative management, particularly in patients with significant comorbidities who may be less tolerant to postoperative physiologic stress. These insights would enable validation of current techniques and establish the foundation for future interventional trials targeting inflammatory pathways to improve postoperative outcomes. The Digestive Health Institute at Northwestern University is uniquely positioned to support this translational research, bridging surgical physiology, inflammation, and patient outcomes.
The investigators hypothesize that:
- Major abdominal wall reconstruction induces a trauma-like systemic inflammatory response characterized by elevations in GM-CSF, IFN-Gamma, IL-1, IL-2, IL-5, IL-6, IL-8, and TNF-alpha with a concomitant decrease in the anti-inflammatory cytokines, IL-4 and IL-10.
- Increased intra-abdominal pressure (IAP) following high-tension closure amplifies cytokine activation and is associated with early postoperative organ dysfunction and increased postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High tension group | – | Other: Not applicable- observational studyMassive incisional ventral hernias with loss of domain undergoing open ventral hernia repair with transversus abdominis release with placement of mesh and closure of fascia under high tension. |
| Low tension group | – | Other: Not applicable- observational studyIncisional ventral hernias undergoing open ventral hernia repair with transversus abdominis release with placement of mesh and closure of fascia under low tension. |
| Control | – | –Healthy human subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include adult patients undergoing elective major abdominal wall reconstruction at Northwestern Memorial Hospital. Patients with large ventral hernias requiring component separation and anticipated primary fascial closure will be eligible.
Key inclusion criteria (7 listed)
- Surgical Participants
- Adults aged 18 years or older
- Scheduled to undergo open retromuscular ventral hernia repair
- Able to provide written informed consent Healthy Control Participants
- Adults aged 18 years or older
Key exclusion criteria (7 listed)
- Emergent or urgent cases
- Pregnancy
- Chronic systemic steroid use or immunosuppressive therapy
- Active infection at the time of enrollment
- Known autoimmune or inflammatory disease
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 |
|---|---|---|
| Not applicable- observational studyThere are no interventions in this observational study. | Other | High tension group, Low tension group |
Primary outcome
Determine whether fascial closure tension correlates with systemic and peritoneal fluid cytokine activation.
Time frame: Baseline through postoperative day 5
Blood and peritoneal fluid will be collected at baseline (intra-operative), immediately following fascial closure and on postoperative days 1, 3, and 5. Serum cytokine concentrations of GM-CSF, IFN-gamma, IL-1, IL-2, IL-5, IL-6, IL-8, and TNF-alpha (inflammatory); IL-4 and IL-10 (anti-inflammatory) will be measured via multiplex immunoassays (Luminex). Cytokine area under the curve will also be calculated to allow analysis of total cytokine exposure over time.
9 secondary outcomes
Differences in peripheral blood mononuclear cells and peritoneal macrophage transcriptomic signatures via bulk RNA sequencing between baseline profiles from healthy control subjects, high-tension and low-tension abdominal wall closures.
Time frame: Baseline through postoperative day 5
Differences in peak intra-abdominal values, intra-abdominal hypertension grading, abdominal perfusion pressure, plateau pressure between baseline profiles from healthy control subjects, high-tension and low-tension abdominal wall closures.
Time frame: Baseline through postoperative day 5
Incidence of respiratory compromise
Time frame: From surgery through hospital discharge (up to 30 days)
Incidence of acute kidney injury
Time frame: From surgery through hospital discharge (up to 30 days)
Incidence of vasopressor use
Time frame: From surgery through hospital discharge (up to 30 days)
Incidence of postoperative ileus
Time frame: From surgery through hospital discharge (up to 30 days)
Incidence of wound complications
Time frame: From surgery through hospital discharge (up to 30 days)
ICU length of stay
Time frame: From surgery through hospital discharge (up to 30 days)
Hospital length of stay
Time frame: From surgery through hospital discharge (up to 30 days)
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 20 Feb 2026.
- Background: PubMed 26135695Rettig TC, Verwijmeren L, Dijkstra IM, Boerma D, van de Garde EM, Noordzij PG. Postoperative Interleukin-6 Level and Early Detection of Complications After Elective Major Abdominal Surgery. Ann Surg. 2016 Jun;263(6):1207-12. doi: 10.1097/SLA.0000000000001342.
- Background: PubMed 17428673Dimopoulou I, Armaganidis A, Douka E, Mavrou I, Augustatou C, Kopterides P, Lyberopoulos P, Tzanela M, Orfanos SE, Pelekanou E, Kostopanagiotou G, Macheras A, Giamarellos-Bourboulis EJ. Tumour necrosis factor-alpha (TNFalpha) and interleukin-10 are crucial mediators in post-operative systemic inflammatory response and determine the occurrence of complications after major abdominal surgery. Cytokine. 2007 Jan;37(1):55-61. doi: 10.1016/j.cyto.2007.02.023. Epub 2007 Apr 10.
- Background: PubMed 15006565Jansson K, Redler B, Truedsson L, Magnuson A, Matthiessen P, Andersson M, Norgren L. Intraperitoneal cytokine response after major surgery: higher postoperative intraperitoneal versus systemic cytokine levels suggest the gastrointestinal tract as the major source of the postoperative inflammatory reaction. Am J Surg. 2004 Mar;187(3):372-7. doi: 10.1016/j.amjsurg.2003.12.019.
- Background: PubMed 8665188Badia JM, Whawell SA, Scott-Coombes DM, Abel PD, Williamson RC, Thompson JN. Peritoneal and systemic cytokine response to laparotomy. Br J Surg. 1996 Mar;83(3):347-8. doi: 10.1002/bjs.1800830316. No abstract available.
- Background: PubMed 15212338Sido B, Teklote JR, Hartel M, Friess H, Buchler MW. Inflammatory response after abdominal surgery. Best Pract Res Clin Anaesthesiol. 2004 Sep;18(3):439-54. doi: 10.1016/j.bpa.2003.12.006.
- Background: PubMed 38151578Li R, Ye JJ, Gan L, Zhang M, Sun D, Li Y, Wang T, Chang P. Traumatic inflammatory response: pathophysiological role and clinical value of cytokines. Eur J Trauma Emerg Surg. 2024 Aug;50(4):1313-1330. doi: 10.1007/s00068-023-02388-5. Epub 2023 Dec 27.
- Background: PubMed 22691844Blatnik JA, Krpata DM, Pesa NL, Will P, Harth KC, Novitsky YW, Rowbottom JR, Rosen MJ. Predicting severe postoperative respiratory complications following abdominal wall reconstruction. Plast Reconstr Surg. 2012 Oct;130(4):836-841. doi: 10.1097/PRS.0b013e318262f160.
- Background: PubMed 26090761Petro CC, Raigani S, Fayezizadeh M, Rowbottom JR, Klick JC, Prabhu AS, Novitsky YW, Rosen MJ. Permissible Intraabdominal Hypertension following Complex Abdominal Wall Reconstruction. Plast Reconstr Surg. 2015 Oct;136(4):868-881. doi: 10.1097/PRS.0000000000001621.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to researchers not involved in specimen processing, data collection or analysis.
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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.
Michael Rosen, MD study director
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Ventral Hernia, run by Northwestern University at 1 site in United States.
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 7 inclusion and 7 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 20 Feb 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 United States. 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 Megan Melland-Smith, MD (312-907-1414, megan.mellandsmith@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether fascial closure tension correlates with systemic and peritoneal fluid cytokine activation. (time frame: Baseline through postoperative day 5). 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 NCT07422584, 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 20 Feb 2026.