Prostate CancerHYDROSPACENCT06451614
SpaceIT Hydrogel System for Perirectal Spacing
A study testing SpaceIT Hydrogel System and Commercially available Boston Scientific Spacer in people with Prostate Cancer, run by Boston Scientific Corporation at 26 sites in 2 countries.
Trial summary
To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SpaceIT Hydrogel System and Commercially available Boston Scientific Spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 30 Oct 2024to 31 Mar 2028
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the following criteria to be eligible for participation in the study:
- Age ≥18 years old
- Subjects must have had pathologically confirmed (by routine hematoxylin and eosin [H\&E] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT
- Subjects must meet ALL of the following:
- Clinical stage T1-T2c (AJCC Ver. 8) tumor AND
- Gleason Score 7 or less as determined from a biopsy taken within 12 months of the Baseline visit AND
- Demonstrated blood prostate specific antigen (PSA) levels ≤20 ng/ml as measured within 6 months of the Baseline visit and prior to commencing androgen deprivation therapy (ADT)
- Subject is able to provide written informed consent, approved by the appropriate Institutional Review Board/Ethics Committee/Research Ethics Board (IRB/EC/REB) of the respective clinical site
Who cannot join
- Prostate > 80 cc
- Subjects who are planning to undergo brachytherapy or focal boost
- Subjects who have magnetic resonance imaging (MRI) evidence of gross posterior extracapsular extension (ECE) of the prostate cancer Note: MRI must be taken within 6 months prior to the Baseline visit
- Subjects who have metastatic disease, other ongoing cancers which are being treated during the study or subjects for whom pelvic lymph node radiotherapy is planned
- Subjects with any prior invasive solid tumor malignancy or hematologic malignancy (except non-melanomatous skin cancer) unless the subject has been disease free and treatment free for a minimum of 3 years
- History of radical prostatectomy, other ablative anti-prostate cancer therapy (e.g., cryotherapy, high intensity focused ultrasound, irreversible electroporation) or previous pelvic irradiation (including prior prostate brachytherapy) at any time prior to screening
Show all 19Show fewer
- History of transurethral prostate surgery (e.g., Transurethral Needle Ablation (TUNA), Transurethral Microwave Therapy (TUMT), Transurethral Resection of the Prostate (TURP)) if performed within 1 year prior to screening
- History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery
- History of or current perirectal disease that may interfere with interpretation of study outcomes, including anal or perianal diseases such as fistula
- Bleeding hemorrhoids requiring medical intervention within the prior three months
- Diagnosed active bleeding disorder or a clinically significant coagulopathy, defined as PTT > 70s or aPTT>35s or INR > 1.4, or platelet count < 100,000 per mm3 Note: Subjects on anticoagulants may be included if the anticoagulant medication can be held for index procedure
- Active inflammatory or infectious process involving the perineum, GI or urinary tract based on positive diagnosis or suspected diagnosis in the presence of fever >38⁰ C, WBC > 12,000/uL
- Inability to undergo pelvic MRI or presence of implants causing severe artifact (e.g. bilateral arthroplasty) that interferes with imaging interpretation for this study at Investigator discretion
- If a subject was enrolled in another investigational drug or device trial that had not completed the primary endpoint or that clinically interfered with this study
- Unable to comply with the study requirements or follow-up schedule
- Any condition the Investigator believed would interfere with the intent of the study or would make participation not in the best interest of the patient
- Known PEG (polyethylene glycol) sensitivity or allergy
- Known iodine sensitivity or allergy
- ADT, if applicable, cannot or was not started 15-60 days prior to the pre-index procedure RT planning imaging and is planned to continue for a total planned duration greater than 6 months
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States23 sites
Emory University Hospital
Atlanta, Georgia, 30308
Midtown Urology Associates
Austin, Texas, 78705
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Associated Urological Specialists
Chicago Ridge, Illinois, 60415
University Hospitals of Cleveland-Hospital
Cleveland, Ohio, 44106
University of Texas, Southwestern Medical Center
Dallas, Texas, 75390
Rio Grande Urology
El Paso, Texas, 79912
Mercy Cancer Center Bon Secours Mercy Healt
Elyria, Ohio, 44035
UroPartners
Glenview, Illinois, 60026
Gibbs Cancer Center and Research Institute
Greer, South Carolina, 29650
Houston Metro Urology
Houston, Texas, 77027
University of Kansas Hospital
Kansas City, Kansas, 66160
Evergreen Hospital Medical Center
Kirkland, Washington, 98034
Orange County Urology Associates
Laguna Hills, California, 92653
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Baptist Hospital of Miami
Miami, Florida, 33176
Integrated Medical Professionals
New York, New York, 10016
Perlmutter Cancer Center - NYU Langone
New York, New York, 10016
Memorial Sloan Kettering
New York, New York, 10065
Orlando Health Cancer Institute
Orlando, Florida, 32806
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
University of Washington Medical Center-Hospital
Seattle, Washington, 98195
Springfield Clinic, LLC
Springfield, Illinois, 62701
Canada3 sites
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Sunnybrook Health Sciences Centre-Hospital
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)
To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.
Read the detailed description
HYDROSPACE study is a prospective, randomized, multicenter study to evaluate the safety and effectiveness of SpaceIT in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.
Subjects randomized to the investigational arm will receive SpaceIT Hydrogel System
Subjects randomized to the control arm will receive a commercially marketed Boston Scientific perirectal hydrogel spacer, SpaceOAR System or SpaceOAR Vue Hydrogel
- Conditions
- Prostate Cancer
- Being tested
- SpaceIT Hydrogel System, Commercially available Boston Scientific Spacer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpaceIT Hydrogel SystemDevice
SpaceIT Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceIT Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceIT Hydrogel System is composed of a radiopaque, biodegradable material designed to maintain space for approximately 12 weeks and be absorbed in about 6 months, sufficient time to support the intended use.
SpaceIT has an iodinated PEG powder making it radiopaque.
Commercially available Boston Scientific SpacerDevice
Boston Scientific's commercially available SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System to reduce the radiation dose delivered to the anterior rectum. SpaceOAR and SpaceOAR Vue are both perirectal spacers. SpaceOAR Vue specifically has an iodinated PEG powder making it radiopaque. SpaceOAR does not contain iodinated PEG powder and is not radiopaque. The SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System maintains space during prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
| Study group | Role | What they receive |
|---|---|---|
| SpaceIT Hydrogel System | Experimental | Subjects randomized to the investigational arm will undergo a hydrogel procedure with the SpaceIT investigational device. Receives: Device: SpaceIT Hydrogel System |
| Commercially available Boston Scientific Spacer | Active comparator | Subjects randomized to the control arm will undergo a hydrogel procedure with the Boston Scientific commercially available SpaceOAR or SpaceOAR VUE device. Receives: Device: Commercially available Boston Scientific Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Acute Grade 3 or greater adverse events.
Acute Grade 3 or greater adverse events, inclusive of all adverse events listed on the existing SpaceOAR product labels, that arise within 90 days of index procedure.
Measured: 90 Days from hydrogel placement procedure
Primary Effectiveness Endpoint - 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose
Clinically relevant dose reduction defined as a 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose in subjects receiving hydrogel.
Measured: 10 days post procedure
Secondary outcomes (13)
Additional Safety Endpoint - Adverse Device Effects (ADEs) requiring additional procedures and/or medications
Adverse Device Effects (ADEs) requiring additional procedures and/or medications
Measured: Up to 24 months
Additional Safety Endpoint - Incidence of acute Grade 2 or greater gastrointestinal (GI) and genitourinary (GU) adverse events (AEs)
Incidence of acute Grade 2 or greater gastrointestinal (GI) and genitourinary (GU) adverse events (AEs) from index procedure up to 3 months
Measured: Up to 90 days
Additional Safety Endpoint - Incidence of late Grade 2 or greater GI and GU adverse events (AEs)
Incidence of late Grade 2 or greater GI and GU adverse events (AEs) from 3 months up to the end of study follow-up
Measured: 91 days up to 24 Months
Additional Effectiveness Endpoint - Visualization of hydrogel
Technical Success: visualization of hydrogel between the posterior prostatic capsule and the anterior rectal wall will be assessed as Yes/No using the MRI performed post hydrogel placement procedure
Measured: 10 days post procedure
Additional Effectiveness Endpoint - Space Creation
Space Creation: Distance between the posterior prostatic capsule and anterior rectal wall will be measured mid gland in millimeters using MRI performed post hydrogel placement procedure
Measured: 10 days post procedure
Additional Effectiveness Endpoint - Absorption
Absorption: Absence of hydrogel in the perirectal space assessed on MRI at 12 months post-hydrogel placement.
Measured: 12 Month post hydrogel placement
Additional Effectiveness Endpoint - Change in radiation dose distributions to the organs at risk
Dose Distribution: Change in radiation dose distributions to the organs at risk (OARs) quantified by computing rectal Dose-Volume Histograms (DVHs) for the dose plans created pre-and post-hydrogel placement.
Measured: 10 days post procedure
Additional Effectiveness Endpoint - Mean and Maximum Rectal Radiation doses
Mean and Maximum Rectal Radiation Doses (in Gy)
Measured: 10 days post procedure
Additional Effectiveness Endpoint - Quality of Life Questionnaire: EQ-5D-5L
Changes from Baseline in EQ-5D-5L
The EQ-5D-5L is a generic questionnaire that assesses a subject's self-reported health status in terms of five dimensions of health: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Subject's overall current health on a vertical visual analogue scale of "0-100" is recorded, where the endpoints are labelled 'The best health you can imagine' at "100" and 'The worst health you can imagine' at "0".
Measured: Baseline up to 24 months
Additional Effectiveness Endpoint - Ease of hydrogel administration
Ease of hydrogel administration. Scored on a Likert scale from 1 to 5 where 1 is Very Difficult and 5 is Very Easy
Measured: 10 days post procedure
Additional Effectiveness Endpoint - Space Maintenance
Space Maintenance: Distance between the posterior prostatic capsule and anterior rectal wall will be measured
Measured: 3 Months post hydrogel placement procedure
Additional Effectiveness Endpoint - Quality of Life Questionnaire: Expanded Prostate Cancer Index Composite (EPIC-26)
Changes from Baseline in Expanded Prostate Cancer Index Composite (EPIC-26)
EPIC-26 is a questionnaire designed to measure health related quality of life (HRQOL) in people with prostate cancer. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Measured: Baseline up to 24 months
Additional Effectiveness Endpoint - Quality of Life Questionnaire, Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
Changes from Baseline in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
The Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start30 Oct 2024
- Primary completion30 Sep 2026
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Baumann, MD, Principal investigator, Springfield Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451614
- Sponsor's protocol ID
- U0755
- Acronym
- HYDROSPACE
- Status last verified
- Oct 2026
- First submitted
- 7 May 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)
- ClinicalTrials.gov ID
- NCT06451614
- Acronym / sponsor ID
- HYDROSPACE / U0755
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 11 Jun 2024 (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.
To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.
Detailed description
HYDROSPACE study is a prospective, randomized, multicenter study to evaluate the safety and effectiveness of SpaceIT in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.
Subjects randomized to the investigational arm will receive SpaceIT Hydrogel System
Subjects randomized to the control arm will receive a commercially marketed Boston Scientific perirectal hydrogel spacer, SpaceOAR System or SpaceOAR Vue Hydrogel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SpaceIT Hydrogel System | Experimental | Device: SpaceIT Hydrogel SystemSubjects randomized to the investigational arm will undergo a hydrogel procedure with the SpaceIT investigational device. |
| Commercially available Boston Scientific Spacer | Active comparator | Device: Commercially available Boston Scientific SpacerSubjects randomized to the control arm will undergo a hydrogel procedure with the Boston Scientific commercially available SpaceOAR or SpaceOAR VUE device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old
- Subjects must have had pathologically confirmed (by routine hematoxylin and eosin [H\&E] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT
- Subjects must meet ALL of the following:
- Subject is able to provide written informed consent, approved by the appropriate Institutional Review Board/Ethics Committee/Research Ethics Board (IRB/EC/REB) of the respective clinical site
Key exclusion criteria (19 listed)
- Prostate > 80 cc
- Subjects who are planning to undergo brachytherapy or focal boost
- Subjects who have magnetic resonance imaging (MRI) evidence of gross posterior extracapsular extension (ECE) of the prostate cancer Note: MRI must be taken within 6 months prior to the Baseline visit
- Subjects who have metastatic disease, other ongoing cancers which are being treated during the study or subjects for whom pelvic lymph node radiotherapy is planned
- Subjects with any prior invasive solid tumor malignancy or hematologic malignancy (except non-melanomatous skin cancer) unless the subject has been disease free and treatment free for a minimum of 3 years
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 |
|---|---|---|
| SpaceIT Hydrogel SystemSpaceIT Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceIT Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceIT Hydrogel System is composed of a radiopaque, biodegradable material designed to maintain space for approximately 12 weeks and be absorbed in about 6 months, sufficient time to support the intended use. SpaceIT has an iodinated PEG powder making it radiopaque. | Device | SpaceIT Hydrogel System |
| Commercially available Boston Scientific SpacerBoston Scientific's commercially available SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System to reduce the radiation dose delivered to the anterior rectum. SpaceOAR and SpaceOAR Vue are both perirectal spacers. SpaceOAR Vue specifically has an iodinated PEG powder making it radiopaque. SpaceOAR does not contain iodinated PEG powder and is not radiopaque. The SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System maintains space during prostate radiotherapy treatment and is completely absorbed by the patient's body over time. | Device | Commercially available Boston Scientific Spacer |
Primary outcome
Primary Safety Endpoint - Acute Grade 3 or greater adverse events.
Time frame: 90 Days from hydrogel placement procedure
Acute Grade 3 or greater adverse events, inclusive of all adverse events listed on the existing SpaceOAR product labels, that arise within 90 days of index procedure.
Primary Effectiveness Endpoint - 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose
Time frame: 10 days post procedure
Clinically relevant dose reduction defined as a 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose in subjects receiving hydrogel.
13 secondary outcomes
Additional Safety Endpoint - Adverse Device Effects (ADEs) requiring additional procedures and/or medications
Time frame: Up to 24 months
Additional Safety Endpoint - Incidence of acute Grade 2 or greater gastrointestinal (GI) and genitourinary (GU) adverse events (AEs)
Time frame: Up to 90 days
Additional Safety Endpoint - Incidence of late Grade 2 or greater GI and GU adverse events (AEs)
Time frame: 91 days up to 24 Months
Additional Effectiveness Endpoint - Visualization of hydrogel
Time frame: 10 days post procedure
Additional Effectiveness Endpoint - Space Creation
Time frame: 10 days post procedure
Additional Effectiveness Endpoint - Absorption
Time frame: 12 Month post hydrogel placement
Additional Effectiveness Endpoint - Change in radiation dose distributions to the organs at risk
Time frame: 10 days post procedure
Additional Effectiveness Endpoint - Mean and Maximum Rectal Radiation doses
Time frame: 10 days post procedure
Additional Effectiveness Endpoint - Quality of Life Questionnaire: EQ-5D-5L
Time frame: Baseline up to 24 months
Additional Effectiveness Endpoint - Ease of hydrogel administration
Time frame: 10 days post procedure
Additional Effectiveness Endpoint - Space Maintenance
Time frame: 3 Months post hydrogel placement procedure
Additional Effectiveness Endpoint - Quality of Life Questionnaire: Expanded Prostate Cancer Index Composite (EPIC-26)
Time frame: Baseline up to 24 months
Additional Effectiveness Endpoint - Quality of Life Questionnaire, Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
Time frame: Baseline up to 24 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 13 Oct 2026.
- 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. This study is not recruiting at the moment.
Brian Baumann, MD principal investigator
Springfield Clinic
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpaceIT Hydrogel System and Commercially available Boston Scientific Spacer in people with Prostate Cancer, run by Boston Scientific Corporation at 26 sites in 2 countries.
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 19 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. 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?
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 Safety Endpoint - Acute Grade 3 or greater adverse events. (time frame: 90 Days from hydrogel placement procedure). 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?
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 13 Oct 2026.