Benign Prostatic HyperplasiaNCT05148156
Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
A study testing Urolift in people with Benign Prostatic Hyperplasia, run by Northwell Health at 1 site in United States.
Trial summary
Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and… Read more about this study
- Who is it for?
- Ages 50 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Urolift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2026to 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 50 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is 50 - 99 years of age
- Subject has provided informed consent
- Subject has diagnosis of prostate cancer requiring SBRT
- Subject is able to complete self-administered questionnaires
- Subject is a surgical candidate for Urolift
- Subject has a diagnosis of BPH
- Medical record documentation of prostate volume from 30-80 ml by TRUS
- Absence of a middle lobe
Who cannot join
- Life expectancy \< 2 years
- Currently enrolled in or plans to enroll in any concurrent drug or device study
- Concurrent androgen deprivation therapy
- Has an active infection (e.g., urinary tract infection or prostatitis)
- Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
- Subject has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
Show all 14Show fewer
- Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
- Diagnosis of lichen sclerosis
- Neurogenic bladder or other neurologic disorder that affects bladder function
- Diagnosis of polyneuropathy (e.g., diabetic)
- History of lower urinary tract surgery
- Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
- Subject has been catheterized or has a PVR \> 400 ml in the 14 days prior to the surgical procedure
- Current diagnosis of bladder stones
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
Northwell Health
Syosset, New York, 11791
Jennifer Polo, CCRC, 516-628-5910, jpolo1@northwell.edu
Bilal Chughtai, MD
About this study
Official title: Reduction of Urinary Toxicity of Stereotactic Body Radiation Therapy (SBRT) With Prostatic Urethral Lift (Urolift)
Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).
Read the detailed description
Urolift is a standard of care treatment for BPH. It involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. It pulls and maintains the opening of a continuous channel through the prostatic urethra. A previous study examined the effect of Urolift on urinary symptoms and urinary medications at six months post-procedure.Urolift was associated with significant urinary improvements measured by IPSS and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Urolift
- Keywords
- stereotactic body radiation therapy, urolift, prostatic urethral lift, dysuria, nocturia, minimally invasive therapy
- Medical subject headings
- Prostatic Hyperplasia, Dysuria, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroliftDevice
Study intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).
| Study group | Role | What they receive |
|---|---|---|
| Urolift | Experimental | This is a single-arm study involving 1 year of follow-up. Study intervention involves a one-time administration of Urolift prior to SBRT for prostate cancer treatment. Receives: Device: Urolift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IPSS scores from baseline and one year post treatment
Patients will take a International Prostatic Symptom Score (IPSS) questionnaire to evaluate symptom severity at baseline and 1 year post treatment. IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.
Measured: At baseline and one year post treatment
Change in IIEF score through study completion, an average of 1 year
Patient will take the International Index of Erectile Function (IIEF) to evaluate changes in sexual function of patients through study completion, an average of 1 year. IIEF scores range from 6 to 30. IIEF lower scores indicate severe erectile dysfunction, while higher scores indicate mild/no erectile dysfunction.
Measured: Through study completion, an average of 1 year
Change in MSHQ through study completion, an average of 1 year
Patients will take the Men's sexual health questionnaire (MSHQ) to further evaluate patients' ability to have sex with their partner(s) or masturbate through study completion, an average of 1 year.
Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Scores range from 16 to 125. Lower scores are considered most symptomatic, higher scores are least symptomatic.
Measured: Through study completion, an average of 1 year
Change in VAS score through study completion, an average of 1 year
Patients will use a visual analog scale (VAS) to describe their pain through study completion, an average of 1 year, to see if there is any changes in pain post treatment. Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain and 0 signifies no pain.
Measured: through study completion, an average of 1 year
Change in OAB-SF score through study completion, an average of 1 year
Patients will use a overactive bladder short form (OAB-SF) to describe their overactive bladder symptoms through study completion, an average of 1 year, to see if there is any changes in symptoms.
The OAB-q SF has 2 main subscales: Symptom bother and Health-Related Quality of Life (HRQOL). The two subscales are summed separately and transformed into scores ranging from 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity and a higher score on the HRQOL scale indicates a better HRQOL, so they are inversely related to each other. Since the OAB-q SF has no total score, higher scores indicate more severe symptoms or better quality of life, respectively. Lower scores indicate less severe symptoms or worse quality of life respectively.
Measured: Through study completion, an average of 1 year
Change in SF-12 score through study completion, an average of 1 year
Patients will use a short form 12 (SF-12) survey to measure their quality of life through study completion, an average of 1 year, to see if there is any changes.
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Change in medication usage through study completion, an average of 1 year
Patients will list their medication usage through study completion, an average of 1 year to see if there is any changes in medications after the study treatment
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start11 Feb 2026
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- This is a single-arm study, involving one time administration of Urolift in outpatient setting prior to stereotactic body radiation therapy
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- NeoTract, Inc., Teleflex
- Responsible party
- Sponsor
- Investigators
- Bilal Chughtai, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148156
- Sponsor's protocol ID
- 24-0684
- Status last verified
- Sep 2026
- First submitted
- 23 Nov 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ng M, Leslie SW, Baradhi KM. Benign Prostatic Hyperplasia. 2024 Oct 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558920/
PubMed 32644346McVary KT. BPH: epidemiology and comorbidities. Am J Manag Care. 2006 Apr;12(5 Suppl):S122-8.
PubMed 16613526Alcaraz A, Hammerer P, Tubaro A, Schroder FH, Castro R. Is there evidence of a relationship between benign prostatic hyperplasia and prostate cancer? Findings of a literature review. Eur Urol. 2009 Apr;55(4):864-73. doi: 10.1016/j.eururo.2008.11.011. Epub 2008 Nov 21.
PubMed 19027219Roehrborn CG. Prostatic Urethral Lift: A Unique Minimally Invasive Surgical Treatment of Male Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urol Clin North Am. 2016 Aug;43(3):357-69. doi: 10.1016/j.ucl.2016.04.008.
PubMed 27476128Chialastri P, Chialastri A, Mueller T. Does Prostatic Urethral Lift Reduce Urinary Medications? Trends in Medical Treatment Before and After Prostatic Urethral Lift. J Endourol. 2021 May;35(5):657-662. doi: 10.1089/end.2020.0848. Epub 2021 Jan 20.
PubMed 33198488Cihan Y. The role and importance of SBRT in prostate cancer. Int Braz J Urol. 2018 Nov-Dec;44(6):1272-1274. doi: 10.1590/S1677-5538.IBJU.2018.0484. No abstract available.
PubMed 30325604Janowski E, Chen LN, Kim JS, Lei S, Suy S, Collins B, Lynch J, Dritschilo A, Collins S. Stereotactic body radiation therapy (SBRT) for prostate cancer in men with large prostates (>/=50 cm(3)). Radiat Oncol. 2014 Nov 15;9:241. doi: 10.1186/s13014-014-0241-3.
PubMed 25398516Mbeutcha A, Chauveinc L, Bondiau PY, Chand ME, Durand M, Chevallier D, Amiel J, Kee DL, Hannoun-Levi JM. Salvage prostate re-irradiation using high-dose-rate brachytherapy or focal stereotactic body radiotherapy for local recurrence after definitive radiation therapy. Radiat Oncol. 2017 Mar 9;12(1):49. doi: 10.1186/s13014-017-0789-9.
PubMed 28274241Fuller DB, Wurzer J, Shirazi R, Bridge SS, Law J, Mardirossian G. High-dose-rate stereotactic body radiation therapy for postradiation therapy locally recurrent prostatic carcinoma: Preliminary prostate-specific antigen response, disease-free survival, and toxicity assessment. Pract Radiat Oncol. 2015 Nov-Dec;5(6):e615-23. doi: 10.1016/j.prro.2015.04.009. Epub 2015 Jun 6.
PubMed 26059509Jiang P, Krockenberger K, Vonthein R, Tereszczuk J, Schreiber A, Liebau S, Huttenlocher S, Imhoff D, Balermpas P, Keller C, Dellas K, Baumann R, Rodel C, Hildebrandt G, Junemann KP, Merseburger AS, Katz A, Ziegler A, Blanck O, Dunst J. Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial. Radiat Oncol. 2017 Aug 18;12(1):138. doi: 10.1186/s13014-017-0872-2.
PubMed 28821268
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Urinary Toxicity of Stereotactic Body Radiation Therapy (SBRT) With Prostatic Urethral Lift (Urolift)
- ClinicalTrials.gov ID
- NCT05148156
- Acronym / sponsor ID
- 24-0684
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- stereotactic body radiation therapy, urolift, prostatic urethral lift, dysuria, nocturia, minimally invasive therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- NeoTract, Inc., Teleflex
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Dec 2021 (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.
Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).
Detailed description
Urolift is a standard of care treatment for BPH. It involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. It pulls and maintains the opening of a continuous channel through the prostatic urethra. A previous study examined the effect of Urolift on urinary symptoms and urinary medications at six months post-procedure.Urolift was associated with significant urinary improvements measured by IPSS and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm study, involving one time administration of Urolift in outpatient setting prior to stereotactic body radiation therapy
| Arm | Type | Receives |
|---|---|---|
| Urolift | Experimental | Device: UroliftThis is a single-arm study involving 1 year of follow-up. Study intervention involves a one-time administration of Urolift prior to SBRT for prostate cancer treatment. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is 50 - 99 years of age
- Subject has provided informed consent
- Subject has diagnosis of prostate cancer requiring SBRT
- Subject is able to complete self-administered questionnaires
- Subject is a surgical candidate for Urolift
Key exclusion criteria (14 listed)
- Life expectancy \< 2 years
- Currently enrolled in or plans to enroll in any concurrent drug or device study
- Concurrent androgen deprivation therapy
- Has an active infection (e.g., urinary tract infection or prostatitis)
- Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
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 |
|---|---|---|
| UroliftStudy intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT). | Device | Urolift |
Primary outcome
Change in IPSS scores from baseline and one year post treatment
Time frame: At baseline and one year post treatment
Patients will take a International Prostatic Symptom Score (IPSS) questionnaire to evaluate symptom severity at baseline and 1 year post treatment. IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.
Change in IIEF score through study completion, an average of 1 year
Time frame: Through study completion, an average of 1 year
Patient will take the International Index of Erectile Function (IIEF) to evaluate changes in sexual function of patients through study completion, an average of 1 year. IIEF scores range from 6 to 30. IIEF lower scores indicate severe erectile dysfunction, while higher scores indicate mild/no erectile dysfunction.
Change in MSHQ through study completion, an average of 1 year
Time frame: Through study completion, an average of 1 year
Patients will take the Men's sexual health questionnaire (MSHQ) to further evaluate patients' ability to have sex with their partner(s) or masturbate through study completion, an average of 1 year. Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Scores range from 16 to 125. Lower scores are considered most symptomatic, higher scores are least symptomatic.
Change in VAS score through study completion, an average of 1 year
Time frame: through study completion, an average of 1 year
Patients will use a visual analog scale (VAS) to describe their pain through study completion, an average of 1 year, to see if there is any changes in pain post treatment. Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain and 0 signifies no pain.
Change in OAB-SF score through study completion, an average of 1 year
Time frame: Through study completion, an average of 1 year
Patients will use a overactive bladder short form (OAB-SF) to describe their overactive bladder symptoms through study completion, an average of 1 year, to see if there is any changes in symptoms. The OAB-q SF has 2 main subscales: Symptom bother and Health-Related Quality of Life (HRQOL). The two subscales are summed separately and transformed into scores ranging from 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity and a higher score on the HRQOL scale indicates a better HRQOL, so they are inversely related to each other. Since the OAB-q SF has no total score, higher scores indicate more severe symptoms or better quality of life, respectively. Lower scores indicate less severe symptoms or worse quality of life respectively.
Change in SF-12 score through study completion, an average of 1 year
Time frame: Through study completion, an average of 1 year
Patients will use a short form 12 (SF-12) survey to measure their quality of life through study completion, an average of 1 year, to see if there is any changes. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'.
1 secondary outcome
Change in medication usage through study completion, an average of 1 year
Time frame: Through study completion, an average of 1 year
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 2026.
- Background: PubMed 32644346Ng M, Leslie SW, Baradhi KM. Benign Prostatic Hyperplasia. 2024 Oct 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558920/
- Background: PubMed 16613526McVary KT. BPH: epidemiology and comorbidities. Am J Manag Care. 2006 Apr;12(5 Suppl):S122-8.
- Background: PubMed 19027219Alcaraz A, Hammerer P, Tubaro A, Schroder FH, Castro R. Is there evidence of a relationship between benign prostatic hyperplasia and prostate cancer? Findings of a literature review. Eur Urol. 2009 Apr;55(4):864-73. doi: 10.1016/j.eururo.2008.11.011. Epub 2008 Nov 21.
- Background: PubMed 27476128Roehrborn CG. Prostatic Urethral Lift: A Unique Minimally Invasive Surgical Treatment of Male Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urol Clin North Am. 2016 Aug;43(3):357-69. doi: 10.1016/j.ucl.2016.04.008.
- Background: PubMed 33198488Chialastri P, Chialastri A, Mueller T. Does Prostatic Urethral Lift Reduce Urinary Medications? Trends in Medical Treatment Before and After Prostatic Urethral Lift. J Endourol. 2021 May;35(5):657-662. doi: 10.1089/end.2020.0848. Epub 2021 Jan 20.
- Background: PubMed 30325604Cihan Y. The role and importance of SBRT in prostate cancer. Int Braz J Urol. 2018 Nov-Dec;44(6):1272-1274. doi: 10.1590/S1677-5538.IBJU.2018.0484. No abstract available.
- Background: PubMed 25398516Janowski E, Chen LN, Kim JS, Lei S, Suy S, Collins B, Lynch J, Dritschilo A, Collins S. Stereotactic body radiation therapy (SBRT) for prostate cancer in men with large prostates (>/=50 cm(3)). Radiat Oncol. 2014 Nov 15;9:241. doi: 10.1186/s13014-014-0241-3.
- Background: PubMed 28274241Mbeutcha A, Chauveinc L, Bondiau PY, Chand ME, Durand M, Chevallier D, Amiel J, Kee DL, Hannoun-Levi JM. Salvage prostate re-irradiation using high-dose-rate brachytherapy or focal stereotactic body radiotherapy for local recurrence after definitive radiation therapy. Radiat Oncol. 2017 Mar 9;12(1):49. doi: 10.1186/s13014-017-0789-9.
- Background: PubMed 26059509Fuller DB, Wurzer J, Shirazi R, Bridge SS, Law J, Mardirossian G. High-dose-rate stereotactic body radiation therapy for postradiation therapy locally recurrent prostatic carcinoma: Preliminary prostate-specific antigen response, disease-free survival, and toxicity assessment. Pract Radiat Oncol. 2015 Nov-Dec;5(6):e615-23. doi: 10.1016/j.prro.2015.04.009. Epub 2015 Jun 6.
- Background: PubMed 28821268Jiang P, Krockenberger K, Vonthein R, Tereszczuk J, Schreiber A, Liebau S, Huttenlocher S, Imhoff D, Balermpas P, Keller C, Dellas K, Baumann R, Rodel C, Hildebrandt G, Junemann KP, Merseburger AS, Katz A, Ziegler A, Blanck O, Dunst J. Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial. Radiat Oncol. 2017 Aug 18;12(1):138. doi: 10.1186/s13014-017-0872-2.
- 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.
Bilal Chughtai, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urolift in people with Benign Prostatic Hyperplasia, run by Northwell Health 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 8 inclusion and 14 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 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 Jennifer Polo, CCRC (516-628-5910, jpolo1@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IPSS scores from baseline and one year post treatment (time frame: At baseline and one year post treatment). The study lists 6 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 NCT05148156, which also lists 10 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 29 Sep 2026.