Benign Prostatic Hyperplasia (BPH)NCT07627178
A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
A study testing Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP), Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Transurethral Enucleation of the Prostate (B-TUEP) in people with Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptom, run by Tanta University at 1 site in Egypt.
Trial summary
This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP). Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptom, Bladder Outlet Obstruction
- What is being tested?
- Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP), Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Transurethral Enucleation of the Prostate (B-TUEP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Oct 2025to 30 May 2027
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male patients diagnosed with BPH
- Clinical diagnosis of BPH with lower urinary tract symptoms.
- IPSS ≥ 20 (severe symptoms)
- Maximum urinary flow rate (Qmax) ≤ 10 mL/s
- Prostate volume >100 mL (measured by transrectal ultrasound)
- Failed medical therapy and fit for operation
Who cannot join
- Prostate cancer (current or history).
- Previous prostate surgery
- Previous urethral surgery.
- Neurogenic bladder dysfunction.
- Active urinary tract infection.
- Severe cardiovascular disease (ASA Class IV).
Show all 9Show fewer
- Previous pelvic radiation.
- Urethral stricture
- Urinary 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.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, Gharbia Governorate, 31111
Omar Khaled Gad, MSc, +201117837272, omar_khaled@med.tanta.edu.eg
Abdullah Salah Al Debeiky, MD, +201221430915, abdullah.aldebeiky@med.tanta.edu.eg
About this study
This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP). Ninety male patients with severe lower urinary tract symptoms (IPSS ≥20, Qmax ≤10 mL/s) who failed medical therapy will be randomized 1:1:1 into three groups of 30. Primary outcomes include IPSS, quality of life score, maximum flow rate (Qmax), and post-void residual at 1, 3, and 6 months postoperatively. Secondary outcomes include operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates assessed by the Clavien-Dindo classification.
Read the detailed description
Benign prostatic hyperplasia (BPH) is a progressive condition causing lower urinary tract symptoms (LUTS) that significantly impairs quality of life in aging men. While medical therapy with alpha-blockers and 5-alpha reductase inhibitors represents first-line management, surgical intervention becomes necessary when symptoms are severe or complications arise.
Anatomical endoscopic enucleation of the prostate has emerged as the size-independent gold standard surgical approach. This prospective randomized controlled trial will be conducted at the Urology Department, Tanta University Hospital (October 2025 - October 2027) following IRB approval (Code: 36265MD479/10/25).
Patients will undergo preoperative evaluation including IPSS, QoL index, IIEF-5, uroflowmetry, transrectal ultrasound, PSA, CBC, coagulation profile, and renal/liver function tests. Intraoperative data will include total operative time, enucleation time, morcellation time, enucleation efficiency (g/min), and estimated blood loss. Postoperative follow-up at 1, 3, and 6 months will assess IPSS, QoL, IIEF-5, Qmax, and post-void residual. Complications will be graded using the Clavien-Dindo classification. Randomization will use the sealed opaque envelope method with 1:1:1 allocation.
- Conditions
- Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptom, Bladder Outlet Obstruction
- Being tested
- Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP), Holmium Laser Enucleation of the Prostate (HoLEP), Bipolar Transurethral Enucleation of the Prostate (B-TUEP)
- Keywords
- Prostate Enucleation, ThuLEP, HOLEP, Bi-TUEP, TFL, BPH Surgery, IPSS, Uroflowmetry
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)Procedure or surgery
Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta thulium fiber laser at 60 watts with a 550 μm thulium fiber. Enucleated tissue was removed using a morcellator.
Holmium Laser Enucleation of the Prostate (HoLEP)Procedure or surgery
Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta holmium YAG laser at 150 watts with a 550 μm holmium fiber. Enucleated tissue was removed using a morcellator.
Bipolar Transurethral Enucleation of the Prostate (B-TUEP)Procedure or surgery
Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator.
| Study group | Role | What they receive |
|---|---|---|
| ThuFLEP Group | Active comparator | 30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber Receives: Procedure: Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) |
| HoLEP Group | Active comparator | 30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber Receives: Procedure: Holmium Laser Enucleation of the Prostate (HoLEP) |
| Bipolar Enucleation Group | Active comparator | 30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy Receives: Procedure: Bipolar Transurethral Enucleation of the Prostate (B-TUEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
Change from baseline in IPSS total score (0-35 scale; higher scores indicate worse urinary symptoms). Scores compared across ThuFLEP, HoLEP, and bipolar enucleation groups.
Measured: at 1, 3 and 6 months post-surgery
Quality of Life Score (QoL)
Change from baseline in the IPSS-linked Quality of Life index (0-6 scale; higher scores indicate worse quality of life due to urinary symptoms).
Measured: Baseline and at 1, 3, and 6 months post-surgery
Maximum Urinary Flow Rate (Qmax)
Change from baseline in maximum urinary flow rate in mL/s as measured by uroflowmetry. Higher values indicate better voiding function.
Measured: Baseline and at 1, 3, and 6 months post-surgery
Post-Void Residual Urine Volume (PVR)
Change from baseline in post-void residual urine volume in mL as measured by transabdominal ultrasound. Lower values indicate better bladder emptying.
Measured: Baseline and at 1, 3, and 6 months post-surgery
Secondary outcomes (7)
Total Operative Time in Minutes
Total surgical time from start of procedure to completion, including enucleation and morcellation phases.
Measured: Intraoperative
Enucleation Efficiency in Grams per Minute
Weight of enucleated prostatic tissue (grams) divided by enucleation time (minutes), reflecting surgical speed and effectiveness.
Measured: Intraoperative
Estimated Blood Loss as Change in Hemoglobin Level
Difference between preoperative and 24-hour postoperative serum hemoglobin levels (g/dL). Greater decrease indicates more blood loss.
Measured: Baseline and 24 hours postoperatively
Catheterization Duration in Days
Number of days from end of surgery until urethral catheter removal, based on resolution of hematuria and clinical assessment.
Measured: Up to 7 days postoperatively
Length of Hospital Stay in Days
Total number of days from surgery to hospital discharge.
Measured: Up to 7 days postoperatively
Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification
Rate and severity of complications including urinary incontinence, urinary tract infection, urethral stricture, and need for reoperation, graded using the Clavien-Dindo classification system (Grade I-V; higher grade indicates more severe complication).
Measured: Up to 6 months postoperatively
Erectile Function Score (IIEF-5)
Change from baseline in International Index of Erectile Function-5 (IIEF-5) questionnaire score (range 5-25; higher scores indicate better erectile function).
Measured: Baseline and at 1, 3, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start21 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Salah Al Debeiky, Tanta University
- Investigators
- Hassan Hussein El-Tatawy, MD, Study director, Tanta University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627178
- Sponsor's protocol ID
- 36265MD479/10/25
- Status last verified
- Oct 2025
- First submitted
- 26 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying published results will be shared after de-identification, including data for primary and secondary outcome measures. Data will be available upon reasonable request to the corresponding author following publication.
Publications
Giulianelli R, Gentile BC, Mirabile G, Tema G, Nacchia A, Albanesi L, Tariciotti P, Mavilla L, Bellangino M, Lopes Mendes L, Rizzo G, Aloisi P, Vincenti G, Lombardo R. Bipolar Plasma Enucleation of the Prostate: 5 Years Outcomes. J Endourol. 2019 May;33(5):396-399. doi: 10.1089/end.2019.0050.
PubMed 30816063Chen YY, Hua WX, Huang YH, Shen XY, You JN, Ding X. The safety and efficacy of five surgical treatments in prostate enucleation: a network meta-analysis. BMC Urol. 2024 Jun 17;24(1):128. doi: 10.1186/s12894-024-01517-5.
PubMed 38886739Kosiba M, Filzmayer M, Welte MN, Hugenell L, Keller AC, Traumann MI, Muller MJ, Kluth LA, Mandel PC, Chun FK, Becker A. Thulium fiber laser vs. holmium laser enucleation of the prostate: results of a prospective randomized non-inferiority trial. World J Urol. 2024 Jan 20;42(1):49. doi: 10.1007/s00345-023-04748-7.
PubMed 38244076Herrmann TRW, Gravas S, de la Rosette JJ, Wolters M, Anastasiadis AG, Giannakis I. Lasers in Transurethral Enucleation of the Prostate-Do We Really Need Them. J Clin Med. 2020 May 10;9(5):1412. doi: 10.3390/jcm9051412.
PubMed 32397634Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28.
PubMed 37667842
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
- ClinicalTrials.gov ID
- NCT07627178
- Acronym / sponsor ID
- 36265MD479/10/25
- Conditions
- Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptom, Bladder Outlet Obstruction
- Keywords
- Prostate Enucleation, ThuLEP, HOLEP, Bi-TUEP, TFL, BPH Surgery, IPSS, Uroflowmetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP). Ninety male patients with severe lower urinary tract symptoms (IPSS ≥20, Qmax ≤10 mL/s) who failed medical therapy will be randomized 1:1:1 into three groups of 30. Primary outcomes include IPSS, quality of life score, maximum flow rate (Qmax), and post-void residual at 1, 3, and 6 months postoperatively. Secondary outcomes include operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates assessed by the Clavien-Dindo classification.
Detailed description
Benign prostatic hyperplasia (BPH) is a progressive condition causing lower urinary tract symptoms (LUTS) that significantly impairs quality of life in aging men. While medical therapy with alpha-blockers and 5-alpha reductase inhibitors represents first-line management, surgical intervention becomes necessary when symptoms are severe or complications arise.
Anatomical endoscopic enucleation of the prostate has emerged as the size-independent gold standard surgical approach. This prospective randomized controlled trial will be conducted at the Urology Department, Tanta University Hospital (October 2025 - October 2027) following IRB approval (Code: 36265MD479/10/25).
Patients will undergo preoperative evaluation including IPSS, QoL index, IIEF-5, uroflowmetry, transrectal ultrasound, PSA, CBC, coagulation profile, and renal/liver function tests. Intraoperative data will include total operative time, enucleation time, morcellation time, enucleation efficiency (g/min), and estimated blood loss. Postoperative follow-up at 1, 3, and 6 months will assess IPSS, QoL, IIEF-5, Qmax, and post-void residual. Complications will be graded using the Clavien-Dindo classification. Randomization will use the sealed opaque envelope method with 1:1:1 allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ThuFLEP Group | Active comparator | Procedure: Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber |
| HoLEP Group | Active comparator | Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber |
| Bipolar Enucleation Group | Active comparator | Procedure: Bipolar Transurethral Enucleation of the Prostate (B-TUEP)30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male patients diagnosed with BPH
- Clinical diagnosis of BPH with lower urinary tract symptoms.
- IPSS ≥ 20 (severe symptoms)
- Maximum urinary flow rate (Qmax) ≤ 10 mL/s
- Prostate volume >100 mL (measured by transrectal ultrasound)
Key exclusion criteria (9 listed)
- Prostate cancer (current or history).
- Previous prostate surgery
- Previous urethral surgery.
- Neurogenic bladder dysfunction.
- Active urinary tract infection.
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 |
|---|---|---|
| Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta thulium fiber laser at 60 watts with a 550 μm thulium fiber. Enucleated tissue was removed using a morcellator. | Procedure or surgery | ThuFLEP Group |
| Holmium Laser Enucleation of the Prostate (HoLEP)Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta holmium YAG laser at 150 watts with a 550 μm holmium fiber. Enucleated tissue was removed using a morcellator. | Procedure or surgery | HoLEP Group |
| Bipolar Transurethral Enucleation of the Prostate (B-TUEP)Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator. | Procedure or surgery | Bipolar Enucleation Group |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: at 1, 3 and 6 months post-surgery
Change from baseline in IPSS total score (0-35 scale; higher scores indicate worse urinary symptoms). Scores compared across ThuFLEP, HoLEP, and bipolar enucleation groups.
Quality of Life Score (QoL)
Time frame: Baseline and at 1, 3, and 6 months post-surgery
Change from baseline in the IPSS-linked Quality of Life index (0-6 scale; higher scores indicate worse quality of life due to urinary symptoms).
Maximum Urinary Flow Rate (Qmax)
Time frame: Baseline and at 1, 3, and 6 months post-surgery
Change from baseline in maximum urinary flow rate in mL/s as measured by uroflowmetry. Higher values indicate better voiding function.
Post-Void Residual Urine Volume (PVR)
Time frame: Baseline and at 1, 3, and 6 months post-surgery
Change from baseline in post-void residual urine volume in mL as measured by transabdominal ultrasound. Lower values indicate better bladder emptying.
7 secondary outcomes
Total Operative Time in Minutes
Time frame: Intraoperative
Enucleation Efficiency in Grams per Minute
Time frame: Intraoperative
Estimated Blood Loss as Change in Hemoglobin Level
Time frame: Baseline and 24 hours postoperatively
Catheterization Duration in Days
Time frame: Up to 7 days postoperatively
Length of Hospital Stay in Days
Time frame: Up to 7 days postoperatively
Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification
Time frame: Up to 6 months postoperatively
Erectile Function Score (IIEF-5)
Time frame: Baseline and at 1, 3, and 6 months postoperatively
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 5 Jun 2026.
- Background: PubMed 30816063Giulianelli R, Gentile BC, Mirabile G, Tema G, Nacchia A, Albanesi L, Tariciotti P, Mavilla L, Bellangino M, Lopes Mendes L, Rizzo G, Aloisi P, Vincenti G, Lombardo R. Bipolar Plasma Enucleation of the Prostate: 5 Years Outcomes. J Endourol. 2019 May;33(5):396-399. doi: 10.1089/end.2019.0050.
- Background: PubMed 38886739Chen YY, Hua WX, Huang YH, Shen XY, You JN, Ding X. The safety and efficacy of five surgical treatments in prostate enucleation: a network meta-analysis. BMC Urol. 2024 Jun 17;24(1):128. doi: 10.1186/s12894-024-01517-5.
- Background: PubMed 38244076Kosiba M, Filzmayer M, Welte MN, Hugenell L, Keller AC, Traumann MI, Muller MJ, Kluth LA, Mandel PC, Chun FK, Becker A. Thulium fiber laser vs. holmium laser enucleation of the prostate: results of a prospective randomized non-inferiority trial. World J Urol. 2024 Jan 20;42(1):49. doi: 10.1007/s00345-023-04748-7.
- Background: PubMed 32397634Herrmann TRW, Gravas S, de la Rosette JJ, Wolters M, Anastasiadis AG, Giannakis I. Lasers in Transurethral Enucleation of the Prostate-Do We Really Need Them. J Clin Med. 2020 May 10;9(5):1412. doi: 10.3390/jcm9051412.
- Background: PubMed 37667842Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28.
- Individual participant dataSharing planned: Yes. Individual participant data underlying published results will be shared after de-identification, including data for primary and secondary outcome measures. Data will be available upon reasonable request to the corresponding author following publication.
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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.
Hassan Hussein El-Tatawy, MD study director
Tanta University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP), Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Transurethral Enucleation of the Prostate (B-TUEP) in people with Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptom, run by Tanta University at 1 site in Egypt.
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 6 inclusion and 9 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 5 Jun 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 Egypt. 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 Abdullah Salah Al Debeiky, MD (+201221430915, abdullah.aldebeiky@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: at 1, 3 and 6 months post-surgery). The study lists 4 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 NCT07627178, which also lists 5 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 5 Jun 2026.