Acute Pulmonary EmbolismEarly Phase 1NCT07032025
Mechanical Thrombectomy for Acute Pulmonary Embolism
A Early Phase 1 study testing Innovative Device Group and Standard Pharmacological Therapy Group in people with Acute Pulmonary Embolism, run by RenJi Hospital.
Trial summary
Research Objective: To prospectively compare the efficacy and safety of a pre-collaboratively developed ultra-thin PTFE minimally invasive thrombectomy system versus standard pharmacological therapy in patients with acute pulmonary embolism (PE), both administered on top of standard care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- Innovative Device Group and Standard Pharmacological Therapy Group
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years (male or female)
- Clinically diagnosed with acute PE
- Right ventricular/left ventricular diameter ratio (RV/LV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)
- Provision of voluntary written informed consent.
Who cannot join
- Target vessel diameter <6 mm
- Calcification, plaque, or stenosis in target lesion
- Sustained systolic blood pressure <90 mmHg for >15 minutes or requiring vasopressors to maintain SBP ≥90 mmHg
- Peak pulmonary artery pressure >70 mmHg
- Hematocrit <28%
- History of chronic pulmonary hypertension
Show all 21Show fewer
- Pre-existing left bundle branch block
- Chronic left heart failure with left ventricular ejection fraction (LVEF) ≤30%
- Renal dysfunction (serum creatinine >1.8 mg/dL or >159 μmol/L)
- Known coagulopathy or bleeding diathesis:
- Platelet count <50×10⁹/L, or International Normalized Ratio (INR) >3
- Contraindications to antiplatelet/anticoagulant therapy
- Cardiothoracic or pulmonary surgery within 7 days prior
- Intracardiac thrombus
- Patients on extracorporeal membrane oxygenation (ECMO)
- Known hypersensitivity to iodinated contrast media
- Significant comorbidities complicating treatment/evaluation:
- Active malignancy Acute infectious disease/sepsis Systemic conditions precluding procedure tolerance Life expectancy <1 year
- Pregnant or lactating women
- Concurrent participation in other drug/device trials
- Other investigator-determined unsuitability
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial of the Catheter-directed Mechanical Thrombectomy Compared to Standard Anticoagulation for Use in the Treatment of Acute Intermediate-risk Pulmonary Embolism.
Research Objective:
To prospectively compare the efficacy and safety of a pre-collaboratively developed ultra-thin PTFE minimally invasive thrombectomy system versus standard pharmacological therapy in patients with acute pulmonary embolism (PE), both administered on top of standard care.
Read more
Research Content:
Patients meeting all the following criteria will be enrolled:
Aged 18-75 years (male or female)
Clinically diagnosed with acute PE
Right ventricular/left ventricular diameter ratio (RV/LV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)
Provision of voluntary written informed consent.
Study Design:
After confirming eligibility, subjects will be randomized at a 1:1 ratio into two groups:
Innovative Device Group: Minimally invasive thrombectomy
Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation
Study Endpoints:
Primary Efficacy Endpoint:
Reduction in RV/LV ratio (measured by CTPA) from baseline to 48 hours post-treatment.
Primary Safety Endpoint:
Incidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment, defined as:
Procedure-related death
Major bleeding (per VARC-2 criteria: life-threatening, disabling, or major bleeding)
Treatment-related clinical deterioration, including:
Unplanned mechanical ventilation
Arterial hypotension (systolic blood pressure <90 mmHg for >1 hour or requiring vasopressors) or shock
Cardiopulmonary resuscitation
Sustained deterioration in oxygenation
Emergency surgical embolectomy.
Key Terminology Notes:
RV/LV: Right Ventricular/Left Ventricular diameter ratio (standard medical abbreviation retained).
VARC-2: Valve Academic Research Consortium-2 (internationally recognized bleeding criteria).
PTFE: Polytetrafluoroethylene (material name preserved).
MAE: Major Adverse Events (acronym defined at first use).
Clinical deterioration: Explicitly specified with objective clinical indicators.
This translation maintains scientific precision while adhering to international clinical trial reporting standards (ICH-GCP). The structure aligns with typical English-language study protocols for clarity and reproducibility.
Read the detailed description
- Research Objective To prospectively evaluate the comparative efficacy and safety of a novel ultra-thin polytetrafluoroethylene (PTFE) minimally invasive thrombectomy system versus guideline-directed pharmacological thrombolysis in patients with acute intermediate-high-risk pulmonary embolism (PE), both administered as adjuncts to standard anticoagulation therapy.
- Study Population Inclusion Criteria: Adults aged 18-75 years (all genders) Acute PE confirmed by computed tomographic pulmonary angiography (CTPA) within 14 days of symptom onset Right ventricular dysfunction defined as RV/LV diameter ratio ≥0.9 on baseline CTPA Provision of written informed consent Exclusion Criteria: Absolute contraindications to thrombolysis (e.g., active bleeding, recent intracranial hemorrhage, major surgery within 14 days) Hemodynamic instability requiring immediate rescue therapy (systolic BP <90 mmHg with end-organ hypoperfusion) Severe renal impairment (eGFR <30 mL/min/1.73m²) or hepatic failure (Child-Pugh Class C) Life expectancy <6 months due to non-PE comorbidities
- Study Design Design: Prospective, multicenter, open-label, randomized controlled trial with blinded endpoint adjudication Randomization: Eligible subjects stratified by PE severity (RV/LV: 0.9-1.0 vs. >1.0) and thrombus burden (main/lobar vs. segmental PA involvement), then randomized 1:1 via centralized web-based system. Intervention Groups: Group A (Innovative Device): Ultra-thin PTFE thrombectomy catheter deployed under fluoroscopic guidance via femoral access Procedure completion within 90 minutes; mandatory peri-procedural unfractionated heparin (target ACT 250-300 s) Post-procedure: Enoxaparin 1 mg/kg BID → transitioned to rivaroxaban 20 mg OD at 24 hours Group B (Standard Therapy): Alteplase infusion: 10 mg bolus + 90 mg over 2 hours (max 100 mg) Concurrent heparin infusion (target aPTT 60-80 s) → switched to rivaroxaban 15 mg BID (Day 1-21) → 20 mg OD thereafter
- Endpoint Definitions Primary Efficacy Endpoint Absolute reduction in RV/LV ratio from baseline to 48 hours post-intervention, measured by blinded core-lab CTPA analysis. Primary Safety Endpoint Composite Major Adverse Events (MAEs) within 48 hours, including: Procedure-related mortality Major bleeding per VARC-2 criteria: Fatal bleeding Intracranial hemorrhage Bleeding causing ≥3 g/dL hemoglobin drop or transfusion of ≥2 units Bleeding requiring surgical intervention Treatment-related clinical deterioration: Unplanned mechanical ventilation Sustained hypotension (SBP <90 mmHg for >1 hour requiring vasopressors) Cardiopulmonary resuscitation New requirement for ECMO or emergency surgical embolectomy
- Statistical Analysis Plan Sample Size: 142 subjects/group (total N=284) providing 90% power (α=0.05) to detect: Efficacy: Mean RV/LR reduction difference of 0.15 (SD=0.3) Safety: 40% relative risk reduction in MAEs (Group A: 10% vs. Group B: 17%) Analysis Sets: Primary analysis: Modified intention-to-treat (mITT; all randomized receiving ≥1 treatment component) Safety analysis: As-treated population Methods: Continuous variables: Mixed-effects repeated measures ANOVA Categorical variables: Cochran-Mantel-Haenszel test with stratification adjustment Time-to-event: Kaplan-Meier with log-rank test
- Quality Assurance Endpoint Adjudication Committee: Blinded to treatment allocation
Data Monitoring: Independent DSMB reviewing unblinded safety data quarterly
Procedure Standardization:
All interventionalists certified via simulation training (≥5 proctored cases)
Centralized core lab for CTPA RV/LV measurements
Ethical Compliance: Approved by institutional review boards at all sites (NCT# pending). Trial conducted per Declaration of Helsinki.
Key Advantages of Expanded Protocol Stratified randomization controls confounding from baseline RV strain heterogeneity.
VARC-2 bleeding criteria enhance comparability with cardiovascular intervention trials.
Core-lab blinded CTPA analysis eliminates measurement bias in efficacy assessment.
Pre-specified safety triggers (e.g., Hb drop thresholds) enable objective MAE classification.
Standardized anticoagulation bridging minimizes post-procedural thrombotic risk variability.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- Innovative Device Group, Standard Pharmacological Therapy Group
- Keywords
- Prospective Studies, Pulmonary Embolism, Thrombectomy
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative Device GroupProcedure or surgery
Catheter-based thrombectomy is performed within 4 hours after baseline CTPA acquisition. Pre-procedural anticoagulation with either low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) is administered prior to thrombectomy. Post-procedural oral anticoagulation is transitioned to rivaroxaban 20 mg once daily (QD).
Standard Pharmacological Therapy GroupDrug
Following thrombolytic agent administration, anticoagulation with rivaroxaban is initiated and maintained at 15 mg twice daily (BID) for the initial 3 weeks, then switched to 20 mg once daily (QD) thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Innovative Device Group: Minimally invasive thrombectomy | Experimental | Not described Receives: Procedure: Innovative Device Group |
| Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation | Active comparator | Not described Receives: Drug: Standard Pharmacological Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
Reduction in RV/LV ratio (measured by CTPA) from baseline to 48 hours post-treatment.
Measured: 48 hours post-treatment.
Primary Safety Endpoint:
Incidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment
Measured: 48 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pulmonary EmbolismStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Pu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032025
- Sponsor's protocol ID
- EARLY-MYO-PE
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang C, Fang P, Zhou D, Xu B, Dai X, Zhang Z, Xie M, Duan Z, Zhang L, Li Y, Zhu Y, Jiang Y, Qie L, Shi H, Feng J, Zhang W, Jin X. Multi-center Randomized Controlled Trial of Catheter-Directed Mechanical Thrombectomy Versus Systemic Thrombolysis in Patients with Acute Intermediate-to-High-Risk Pulmonary Embolism: Study Protocol. Cardiovasc Intervent Radiol. 2026 Jun;49(6):1210-1218. doi: 10.1007/s00270-026-04433-3. Epub 2026 Apr 29.
PubMed 42056311
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial of the Catheter-directed Mechanical Thrombectomy Compared to Standard Anticoagulation for Use in the Treatment of Acute Intermediate-risk Pulmonary Embolism.
- ClinicalTrials.gov ID
- NCT07032025
- Acronym / sponsor ID
- EARLY-MYO-PE
- Conditions
- Acute Pulmonary Embolism
- Keywords
- Prospective Studies, Pulmonary Embolism, Thrombectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Jun 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.
Research Objective:
To prospectively compare the efficacy and safety of a pre-collaboratively developed ultra-thin PTFE minimally invasive thrombectomy system versus standard pharmacological therapy in patients with acute pulmonary embolism (PE), both administered on top of standard care.
Research Content:
Patients meeting all the following criteria will be enrolled:
Aged 18-75 years (male or female)
Clinically diagnosed with acute PE
Right ventricular/left ventricular diameter ratio (RV/LV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)
Provision of voluntary written informed consent.
Study Design:
After confirming eligibility, subjects will be randomized at a 1:1 ratio into two groups:
Innovative Device Group: Minimally invasive thrombectomy
Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation
Study Endpoints:
Primary Efficacy Endpoint:
Reduction in RV/LV ratio (measured by CTPA) from baseline to 48 hours post-treatment.
Primary Safety Endpoint:
Incidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment, defined as:
Procedure-related death
Major bleeding (per VARC-2 criteria: life-threatening, disabling, or major bleeding)
Treatment-related clinical deterioration, including:
Unplanned mechanical ventilation
Arterial hypotension (systolic blood pressure <90 mmHg for >1 hour or requiring vasopressors) or shock
Cardiopulmonary resuscitation
Sustained deterioration in oxygenation
Emergency surgical embolectomy.
Key Terminology Notes:
RV/LV: Right Ventricular/Left Ventricular diameter ratio (standard medical abbreviation retained).
VARC-2: Valve Academic Research Consortium-2 (internationally recognized bleeding criteria).
PTFE: Polytetrafluoroethylene (material name preserved).
MAE: Major Adverse Events (acronym defined at first use).
Clinical deterioration: Explicitly specified with objective clinical indicators.
This translation maintains scientific precision while adhering to international clinical trial reporting standards (ICH-GCP). The structure aligns with typical English-language study protocols for clarity and reproducibility.
Detailed description
- Research Objective To prospectively evaluate the comparative efficacy and safety of a novel ultra-thin polytetrafluoroethylene (PTFE) minimally invasive thrombectomy system versus guideline-directed pharmacological thrombolysis in patients with acute intermediate-high-risk pulmonary embolism (PE), both administered as adjuncts to standard anticoagulation therapy.
- Study Population Inclusion Criteria: Adults aged 18-75 years (all genders) Acute PE confirmed by computed tomographic pulmonary angiography (CTPA) within 14 days of symptom onset Right ventricular dysfunction defined as RV/LV diameter ratio ≥0.9 on baseline CTPA Provision of written informed consent Exclusion Criteria: Absolute contraindications to thrombolysis (e.g., active bleeding, recent intracranial hemorrhage, major surgery within 14 days) Hemodynamic instability requiring immediate rescue therapy (systolic BP <90 mmHg with end-organ hypoperfusion) Severe renal impairment (eGFR <30 mL/min/1.73m²) or hepatic failure (Child-Pugh Class C) Life expectancy <6 months due to non-PE comorbidities
- Study Design Design: Prospective, multicenter, open-label, randomized controlled trial with blinded endpoint adjudication Randomization: Eligible subjects stratified by PE severity (RV/LV: 0.9-1.0 vs. >1.0) and thrombus burden (main/lobar vs. segmental PA involvement), then randomized 1:1 via centralized web-based system. Intervention Groups: Group A (Innovative Device): Ultra-thin PTFE thrombectomy catheter deployed under fluoroscopic guidance via femoral access Procedure completion within 90 minutes; mandatory peri-procedural unfractionated heparin (target ACT 250-300 s) Post-procedure: Enoxaparin 1 mg/kg BID → transitioned to rivaroxaban 20 mg OD at 24 hours Group B (Standard Therapy): Alteplase infusion: 10 mg bolus + 90 mg over 2 hours (max 100 mg) Concurrent heparin infusion (target aPTT 60-80 s) → switched to rivaroxaban 15 mg BID (Day 1-21) → 20 mg OD thereafter
- Endpoint Definitions Primary Efficacy Endpoint Absolute reduction in RV/LV ratio from baseline to 48 hours post-intervention, measured by blinded core-lab CTPA analysis. Primary Safety Endpoint Composite Major Adverse Events (MAEs) within 48 hours, including: Procedure-related mortality Major bleeding per VARC-2 criteria: Fatal bleeding Intracranial hemorrhage Bleeding causing ≥3 g/dL hemoglobin drop or transfusion of ≥2 units Bleeding requiring surgical intervention Treatment-related clinical deterioration: Unplanned mechanical ventilation Sustained hypotension (SBP <90 mmHg for >1 hour requiring vasopressors) Cardiopulmonary resuscitation New requirement for ECMO or emergency surgical embolectomy
- Statistical Analysis Plan Sample Size: 142 subjects/group (total N=284) providing 90% power (α=0.05) to detect: Efficacy: Mean RV/LR reduction difference of 0.15 (SD=0.3) Safety: 40% relative risk reduction in MAEs (Group A: 10% vs. Group B: 17%) Analysis Sets: Primary analysis: Modified intention-to-treat (mITT; all randomized receiving ≥1 treatment component) Safety analysis: As-treated population Methods: Continuous variables: Mixed-effects repeated measures ANOVA Categorical variables: Cochran-Mantel-Haenszel test with stratification adjustment Time-to-event: Kaplan-Meier with log-rank test
- Quality Assurance Endpoint Adjudication Committee: Blinded to treatment allocation
Data Monitoring: Independent DSMB reviewing unblinded safety data quarterly
Procedure Standardization:
All interventionalists certified via simulation training (≥5 proctored cases)
Centralized core lab for CTPA RV/LV measurements
Ethical Compliance: Approved by institutional review boards at all sites (NCT# pending). Trial conducted per Declaration of Helsinki.
Key Advantages of Expanded Protocol Stratified randomization controls confounding from baseline RV strain heterogeneity.
VARC-2 bleeding criteria enhance comparability with cardiovascular intervention trials.
Core-lab blinded CTPA analysis eliminates measurement bias in efficacy assessment.
Pre-specified safety triggers (e.g., Hb drop thresholds) enable objective MAE classification.
Standardized anticoagulation bridging minimizes post-procedural thrombotic risk variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innovative Device Group: Minimally invasive thrombectomy | Experimental | Procedure: Innovative Device Group |
| Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation | Active comparator | Drug: Standard Pharmacological Therapy Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-75 years (male or female)
- Clinically diagnosed with acute PE
- Right ventricular/left ventricular diameter ratio (RV/LV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)
- Provision of voluntary written informed consent.
Key exclusion criteria (21 listed)
- Target vessel diameter <6 mm
- Calcification, plaque, or stenosis in target lesion
- Sustained systolic blood pressure <90 mmHg for >15 minutes or requiring vasopressors to maintain SBP ≥90 mmHg
- Peak pulmonary artery pressure >70 mmHg
- Hematocrit <28%
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 |
|---|---|---|
| Innovative Device GroupCatheter-based thrombectomy is performed within 4 hours after baseline CTPA acquisition. Pre-procedural anticoagulation with either low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) is administered prior to thrombectomy. Post-procedural oral anticoagulation is transitioned to rivaroxaban 20 mg once daily (QD). | Procedure or surgery | Innovative Device Group: Minimally invasive thrombectomy |
| Standard Pharmacological Therapy GroupFollowing thrombolytic agent administration, anticoagulation with rivaroxaban is initiated and maintained at 15 mg twice daily (BID) for the initial 3 weeks, then switched to 20 mg once daily (QD) thereafter. | Drug | Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation |
Primary outcome
Primary Efficacy Endpoint
Time frame: 48 hours post-treatment.
Reduction in RV/LV ratio (measured by CTPA) from baseline to 48 hours post-treatment.
Primary Safety Endpoint:
Time frame: 48 hours post-treatment
Incidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment
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 22 Jun 2025.
- Derived from this study: PubMed 42056311Wang C, Fang P, Zhou D, Xu B, Dai X, Zhang Z, Xie M, Duan Z, Zhang L, Li Y, Zhu Y, Jiang Y, Qie L, Shi H, Feng J, Zhang W, Jin X. Multi-center Randomized Controlled Trial of Catheter-Directed Mechanical Thrombectomy Versus Systemic Thrombolysis in Patients with Acute Intermediate-to-High-Risk Pulmonary Embolism: Study Protocol. Cardiovasc Intervent Radiol. 2026 Jun;49(6):1210-1218. doi: 10.1007/s00270-026-04433-3. Epub 2026 Apr 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Innovative Device Group and Standard Pharmacological Therapy Group in people with Acute Pulmonary Embolism, run by RenJi Hospital.
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 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
Primary Efficacy Endpoint (time frame: 48 hours post-treatment.). The study lists 2 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 NCT07032025, which also lists 1 linked publication.
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 22 Jun 2025.