Pulmonary Valve InsufficiencyGECTNCT05809856
Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve
A study testing GrOwnValve - novel heart valve replacement approach in people with Pulmonary Valve Insufficiency, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Valve Insufficiency
- What is being tested?
- GrOwnValve - novel heart valve replacement approach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- 18 Dec 2023to 31 Dec 2031
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Sufficient appropriate tissue (preferably: Pericardium for pericardiectomy via thoracoscopy or thoracotomy, or sternotomy; other options are fascia lata, rectus fascia, peritoneum or diaphragm)
- Any of the following by transthoracic echocardiography and/or Cardiac Magnet Resonance Imaging:
- For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR mean systolic gradient across PV or RVOT ≥ 35 mmHg
- For patients in NYHA Classification I: Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction and/or mean PV or RVOT systolic gradient ≥ 40 mmHg
- Right ventricular ejection fraction (RV-EF): <40%.
- Right ventricular end-diastolic volume (RVEDV): >150 ml/m2 (body surface area)
- Written informed consent provided by study subjects obtained before any research-related test is performed
Who cannot join
- Active endocarditis or myocarditis or within 3 months before the screening date
- Patients unwilling or unable to provide written informed consent or comply with follow-up requirements
- Obstruction of the central veins (including the superior and inferior vena cava, and bilateral iliac veins) such that the Ensemble-delivery system/ Performer™ - Guiding Sheath/ Extra Large Check-Flo® or GORE® DrySeal Flex + Ballon-in-Ballon-catheter cannot be advanced to the heart via a transvenous approach from either femoral vein or internal jugular
- Requires emergency surgery
- Recipient of transplanted organs or currently an organ transplant candidate
- Pulmonary hypertension
Show all 22Show fewer
- Connective tissue disorders
- Coronary artery disease
- Immunosuppressive disease
- Estimated survival of less than 6 months
- Fertile females unable to take adequate contraceptive precautions (PEARL- Index < 1%)
- Females who are pregnant, or are currently breastfeeding an infant
- Acute myocardial infarction within 30 days of the screening date
- Stroke confirmed by CT, cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months before the screening date
- Hemodynamic or respiratory instability requiring inotropic or/and mechanical circulatory support, or mechanical ventilation within 30 days before the screening date
- Severe left ventricular systolic dysfunction with ejection fraction ≤ 20% or evidence of an intra-cardiac mass, thrombus, or vegetation assessed by echocardiography before the screening date
- Renal insufficiency with creatinine level 2.5 mg/dl within 60 days before the screening date
- Leukopenia with WBC <3.5 x 109/L anemia with Hgb <10 g/dl, or thrombocytopenia with platelet count <50x103/l accompanied by a history of bleeding diathesis or coagulopathy within 60 days before the screening date
- Adult subject is an illicit drug user, alcohol abuser, or unable to give informed consent
- Subject is institutionalized by court order or by order of authority (e.g. prisoner, untreated psychiatry; limited compliance)
- Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than six months Inability to comply with all of the study procedures and follow-up visits
- Subjects who are dependent on the sponsor or investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der Charité
Berlin, State of Berlin, 13353
Svenja Broschag, MSc, svenja.broschag@dhzc-charite.de
Marvin Steitz, MSc, marvin.steitz@dhzc-charite.de
About this study
Official title: A First-in-Human Feasibility Study to Evaluate the Safety (and Short Term Effectiveness) of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve [GECT]
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
Read the detailed description
Defective or diseased pulmonary heart valves do not recover. If left untreated, pediatric and adult patients alike, face serious risks of progressive heart failure and death. Due to the insufficient care of children with heart valve defects, the valve replacement with regenerative, remodeling, and growth potential remains an unmet medical need. Therefore, the first pediatric heart valve (GrOwnValve) was developed to overcome the current limitations, which should offer regenerative potential that adapts to the somatic growth of the child. The study aims to investigate the safety and provide the first initial efficacy estimates of the transcatheter implantable GrOwnValve. This first prospective, non-randomized, single center trial in 7 study subjects (≥ 18 years of age) should be conducted to assess the devices safety for clinical application.
The novel interdisciplinary solution approach is based on the combination of individualized 3D modeling, viable autologous tissue (contrary to all other prosthetic heart valves on the market), and preservation of the regenerative capacity of the valve replacement by maintaining the vitality of heart valve cells and tissue through the application of a novel crosslinker in the tissue preparation process. The GrOwnValve prothesis has the potential to be the first durable and regenerative heart valve for adults. Fabrication is performed on-demand in the operating room. The trial should be the first clinical investigation assessing this novel heart valve replacement approach. We are aiming for the GrOwnValve to be the standard of care, replacing current solutions.
- Conditions
- Pulmonary Valve Insufficiency
- Being tested
- GrOwnValve - novel heart valve replacement approach
- Keywords
- Heart Valve Replacement, Pulmonary Valve, Congenital Heart Diseases, Transcatheter Valve, Medical Need, Durable, One-time-solution, Autologous Living Tissue
- Medical subject headings
- Pulmonary Valve Insufficiency, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrOwnValve - novel heart valve replacement approachDevice
The autologous GrOwnValve is implanted into a stent before it is implanted via minimal-invasive transcatheter technique into the patients with high-grade pulmonary valve insufficiency and right ventricular dilatation. Control intervention/Reference test: Since the study is designed for investigating the safety of the procedure, there will not be a control group. However, the outcomes will be compared as a non-inferiority analysis with the standard of current medical care (Edwards SAPIEN 3 or Medtronic's Melody, both bioprosthetic transcatheter pulmonary valves).
| Study group | Role | What they receive |
|---|---|---|
| Implantation of autologous GrOwnValve | Experimental | Implantation of autologous GrOwnValve via minimal-invasive transcatheter technique into patients with high-grade pulmonary valve insufficiency and right ventricular dilatation. Receives: Device: GrOwnValve - novel heart valve replacement approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
(valve-related, sudden, cardiac, and all-cause death)
Measured: Up to 5 Years Follow-Up
Major bleeding
Assessment if device-related major bleeding has occured by laboratory + echo + CT
Measured: Up to 1 Year Follow-Up
Reoperation
Questioning if device-related re-operation occured
Measured: Up to 5 Years Follow-Up
Acute device-related complications
Measurement tool: Spiroergometry
- Parameters: cardiac rhythm, load duration, reason for termination, Heart rate at rest, blood pressure, maximum load level, VE/VCO2, PetCO2, VE/VCO2 slope, VO2, Respiratory rate, VD/VT, SpO2, RER, Borg score, FEV1, FVC
Measured: Up to 5 Years Follow-Up
Oxygen supply
Measurement tool: Spiroergometry Parameters: cardiac rhythm, load duration, reason for termination, Heart rate at rest, blood pressure, maximum load level, VE/VCO2, PetCO2, VE/VCO2 slope, VO2, Respiratory rate, VD/VT, SpO2, RER, Borg score, FEV1, FVC
Measured: Up to 5 Years Follow-Up
Valve opening and closure behavior
Measurement tool: Echocardiography + Magnetic resonance imaging Parameter: 1.) blood flow velocity / stenosis, 2.) stiff leaflet, 3.) valve opening area Decision rule: blood flow velocity >4 m/s, abnormal or no leaflet motion when compared to neighboring leaflets, > 0.70 for 17 diameter, > 0.85 for 19, > 1.05 for 21, > 1.25 for 23, > 1.45 for 25, > 1.70 for 27, 1.95 for 29, and 2.25 for 31 mm annulus diameter
Measured: Up to 5 Years Follow-Up
Valve closure behavior
Measurement tool: Echocardiography + Magnetic resonance imaging Parameter: 1.) vena contracta, 2.) Proximal Isovelocity Surface Area (PISA) radius, 3.) Effective regurgitation orifice area (EROA=2π*r2*Va/Vmax), (iv) sagging leaflet Decision rule: 1.) less than or equal to 15% of the diameter of PA/stent at a Nyquist limit of 0.5-0.6 m/s, frame rate >20/sec, gain adjusted, sector small, 2.) equal or minor to 4 mm at a Nyquist limit of 0.2-0.4 m/s, frame rate >20/sec, gain adjusted, variance off, sector small, 3.) < or equal to 3% of the total cross-sectional area of the valve, 4.) n.a
Measured: Up to 5 Years Follow-Up
Heart rhythm
Assessment if new or higher grade of cardiac arrhythmia occured, i.e. newly ventricular extra systoly
Measured: Up to 5 Years Follow-Up
Position and condition of the stent and structures
Measurement tool: Echocardiography + Magnetic resonance imaging + computed tomography Parameter: 1.) GrOwnValve annulus, 2.) no broken struts of the valve stent Decision rule: 1.) +/- 1.5 mm from the native pulmonary valve annulus, 2.) n.a.
Measured: Up to 1 Year Follow-Up
Blood flow
Assessment of backflow and volume of blood by echo + MRI
Measured: Up to 1 Year Follow-Up
Secondary outcomes (7)
Availability of pericardium or other tissue for preparation of autologous pulmonary valve graft
Visual assessment of pericardium
Measured: Procedure (intra-operatively)
Post-procedure length of stay
Post-procedure hospital stay in days.
Measured: Up to day of discharge ( ≤ 30 days)
Ventilation time
Timepoints: Procedure Assessment: How long was the ventilation time for each patient within the allocation?
Measured: Procedure (intra-operatively)
Freedom from conduction disturbances and arrhythmias need for permanent pacemaker implantation
Timepoints: Procedure + Discharge + Visit 1 Assessment: Is the implantation of a permanent pacemaker necessary due to disturbances or arrhythmias?
Measured: Up to 3 months Follow-Up
(Re-)Hospitalization
Timepoints: Discharge, Visit 1, Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8 Assessment: Is a (Re-)Hospitalization necessary due to procedure- or device-related complications?
Measured: Up to 60 months (5 years) Follow-Up
Comparison of pericardiectomy (if applicable) via thoracoscopy vs. thoracotomy
Timepoints: Procedure Assessment: How was the pericardiectomy conducted, via thoracoscopy or thoracotomy
Measured: Procedure (intra-operatively)
Procedure-related death, major bleeding, reoperation, and other complications.
Assessment of the GrOwnValve procedure's safety. Therefore, procedure-related death, major bleeding, reoperation, and other complications will be documented combined and individually for 6 months. Whenever the procedure evaluates as "not safe", the reasons will be documented.
Measured: Follow-Up for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start18 Dec 2023
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-inferiority analysis with standard of current medical care
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- GrOwnValve GmbH
- Responsible party
- Principal investigator, Univ.-Prof. Dr. med. Frank Edelmann, Charite University, Berlin, Germany
- Investigators
- Boris Schmitt, Dr., Study director, Charité UNiveristätsmedizin Berlin, Deutsches Herzzentreum der Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809856
- Sponsor's protocol ID
- 100592731
- Acronym
- GECT
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2022
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Feasibility Study to Evaluate the Safety (and Short Term Effectiveness) of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve [GECT]
- ClinicalTrials.gov ID
- NCT05809856
- Acronym / sponsor ID
- GECT / 100592731
- Conditions
- Pulmonary Valve Insufficiency
- Keywords
- Heart Valve Replacement, Pulmonary Valve, Congenital Heart Diseases, Transcatheter Valve, Medical Need, Durable, One-time-solution, Autologous Living Tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- GrOwnValve GmbH
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 12 Apr 2023 (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.
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
Detailed description
Defective or diseased pulmonary heart valves do not recover. If left untreated, pediatric and adult patients alike, face serious risks of progressive heart failure and death. Due to the insufficient care of children with heart valve defects, the valve replacement with regenerative, remodeling, and growth potential remains an unmet medical need. Therefore, the first pediatric heart valve (GrOwnValve) was developed to overcome the current limitations, which should offer regenerative potential that adapts to the somatic growth of the child. The study aims to investigate the safety and provide the first initial efficacy estimates of the transcatheter implantable GrOwnValve. This first prospective, non-randomized, single center trial in 7 study subjects (≥ 18 years of age) should be conducted to assess the devices safety for clinical application.
The novel interdisciplinary solution approach is based on the combination of individualized 3D modeling, viable autologous tissue (contrary to all other prosthetic heart valves on the market), and preservation of the regenerative capacity of the valve replacement by maintaining the vitality of heart valve cells and tissue through the application of a novel crosslinker in the tissue preparation process. The GrOwnValve prothesis has the potential to be the first durable and regenerative heart valve for adults. Fabrication is performed on-demand in the operating room. The trial should be the first clinical investigation assessing this novel heart valve replacement approach. We are aiming for the GrOwnValve to be the standard of care, replacing current solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-inferiority analysis with standard of current medical care
| Arm | Type | Receives |
|---|---|---|
| Implantation of autologous GrOwnValve | Experimental | Device: GrOwnValve - novel heart valve replacement approachImplantation of autologous GrOwnValve via minimal-invasive transcatheter technique into patients with high-grade pulmonary valve insufficiency and right ventricular dilatation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Sufficient appropriate tissue (preferably: Pericardium for pericardiectomy via thoracoscopy or thoracotomy, or sternotomy; other options are fascia lata, rectus fascia, peritoneum or diaphragm)
- Any of the following by transthoracic echocardiography and/or Cardiac Magnet Resonance Imaging:
- Written informed consent provided by study subjects obtained before any research-related test is performed
Key exclusion criteria (22 listed)
- Active endocarditis or myocarditis or within 3 months before the screening date
- Patients unwilling or unable to provide written informed consent or comply with follow-up requirements
- Obstruction of the central veins (including the superior and inferior vena cava, and bilateral iliac veins) such that the Ensemble-delivery system/ Performer™ - Guiding Sheath/ Extra Large Check-Flo® or GORE® DrySeal Flex + Ballon-in-Ballon-catheter cannot be advanced to the heart via a transvenous approach from either femoral vein or internal jugular
- Requires emergency surgery
- Recipient of transplanted organs or currently an organ transplant candidate
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 |
|---|---|---|
| GrOwnValve - novel heart valve replacement approachThe autologous GrOwnValve is implanted into a stent before it is implanted via minimal-invasive transcatheter technique into the patients with high-grade pulmonary valve insufficiency and right ventricular dilatation. Control intervention/Reference test: Since the study is designed for investigating the safety of the procedure, there will not be a control group. However, the outcomes will be compared as a non-inferiority analysis with the standard of current medical care (Edwards SAPIEN 3 or Medtronic's Melody, both bioprosthetic transcatheter pulmonary valves). | Device | Implantation of autologous GrOwnValve |
Primary outcome
Death
Time frame: Up to 5 Years Follow-Up
(valve-related, sudden, cardiac, and all-cause death)
Major bleeding
Time frame: Up to 1 Year Follow-Up
Assessment if device-related major bleeding has occured by laboratory + echo + CT
Reoperation
Time frame: Up to 5 Years Follow-Up
Questioning if device-related re-operation occured
Acute device-related complications
Time frame: Up to 5 Years Follow-Up
Measurement tool: Spiroergometry o Parameters: cardiac rhythm, load duration, reason for termination, Heart rate at rest, blood pressure, maximum load level, VE/VCO2, PetCO2, VE/VCO2 slope, VO2, Respiratory rate, VD/VT, SpO2, RER, Borg score, FEV1, FVC
Oxygen supply
Time frame: Up to 5 Years Follow-Up
Measurement tool: Spiroergometry Parameters: cardiac rhythm, load duration, reason for termination, Heart rate at rest, blood pressure, maximum load level, VE/VCO2, PetCO2, VE/VCO2 slope, VO2, Respiratory rate, VD/VT, SpO2, RER, Borg score, FEV1, FVC
Valve opening and closure behavior
Time frame: Up to 5 Years Follow-Up
Measurement tool: Echocardiography + Magnetic resonance imaging Parameter: 1.) blood flow velocity / stenosis, 2.) stiff leaflet, 3.) valve opening area Decision rule: blood flow velocity >4 m/s, abnormal or no leaflet motion when compared to neighboring leaflets, > 0.70 for 17 diameter, > 0.85 for 19, > 1.05 for 21, > 1.25 for 23, > 1.45 for 25, > 1.70 for 27, 1.95 for 29, and 2.25 for 31 mm annulus diameter
Valve closure behavior
Time frame: Up to 5 Years Follow-Up
Measurement tool: Echocardiography + Magnetic resonance imaging Parameter: 1.) vena contracta, 2.) Proximal Isovelocity Surface Area (PISA) radius, 3.) Effective regurgitation orifice area (EROA=2π*r2*Va/Vmax), (iv) sagging leaflet Decision rule: 1.) less than or equal to 15% of the diameter of PA/stent at a Nyquist limit of 0.5-0.6 m/s, frame rate >20/sec, gain adjusted, sector small, 2.) equal or minor to 4 mm at a Nyquist limit of 0.2-0.4 m/s, frame rate >20/sec, gain adjusted, variance off, sector small, 3.) < or equal to 3% of the total cross-sectional area of the valve, 4.) n.a
Heart rhythm
Time frame: Up to 5 Years Follow-Up
Assessment if new or higher grade of cardiac arrhythmia occured, i.e. newly ventricular extra systoly
Position and condition of the stent and structures
Time frame: Up to 1 Year Follow-Up
Measurement tool: Echocardiography + Magnetic resonance imaging + computed tomography Parameter: 1.) GrOwnValve annulus, 2.) no broken struts of the valve stent Decision rule: 1.) +/- 1.5 mm from the native pulmonary valve annulus, 2.) n.a.
Blood flow
Time frame: Up to 1 Year Follow-Up
Assessment of backflow and volume of blood by echo + MRI
7 secondary outcomes
Availability of pericardium or other tissue for preparation of autologous pulmonary valve graft
Time frame: Procedure (intra-operatively)
Post-procedure length of stay
Time frame: Up to day of discharge ( ≤ 30 days)
Ventilation time
Time frame: Procedure (intra-operatively)
Freedom from conduction disturbances and arrhythmias need for permanent pacemaker implantation
Time frame: Up to 3 months Follow-Up
(Re-)Hospitalization
Time frame: Up to 60 months (5 years) Follow-Up
Comparison of pericardiectomy (if applicable) via thoracoscopy vs. thoracotomy
Time frame: Procedure (intra-operatively)
Procedure-related death, major bleeding, reoperation, and other complications.
Time frame: Follow-Up for 6 months
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 29 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Boris Schmitt, Dr. study director
Charité UNiveristätsmedizin Berlin, Deutsches Herzzentreum der Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GrOwnValve - novel heart valve replacement approach in people with Pulmonary Valve Insufficiency, run by Charite University, Berlin, Germany at 1 site in Germany.
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 8 inclusion and 22 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Boris Schmitt, Dr. (+49 30 4593 2846, boris.schmitt@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Up to 5 Years Follow-Up). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.