Prostatic Hyperplasia of the Medial LobeNCT06177821
Rezum for 30-80ml Patients With Moderate-severe LUTS to Study Surgical Principles for Median Lobe Enlargement
A study testing Rezum® in people with Prostatic Hyperplasia of the Medial Lobe, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study was created to determine the safety and efficacy of treating prostatic hyperplasia with or without prominent median lobe enlargement with the REZUM technique. The systematic implementation of decisions for the location, vapor time, and the number of injections contributes to the Rezum procedure… Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Prostatic Hyperplasia of the Medial Lobe
- What is being tested?
- Rezum®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jun 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 50 to 85 years who have been diagnosed with benign prostatic hyperplasia at Seoul National University Hospital and are scheduled to undergo endoscopic surgery.
- benign prostatic hyperplasia ≥ 30 and < 80 ml
- Patients who have given written informed consent to participate in the study according to their age
- A urinary symptom score (International ProstateSymptom Score [IPSS] moderated (8-19 points) to severe (20-35 points)
- Measured Postvoiding Residual (PVR) <250 mL
Who cannot join
- History of prostate or bladder cancer, neurogenic bladder, bladder calculus, or clinically significant bladder diverticulum
- Active infection, treatment for chronic prostatitis
- Diagnosis of urethral stricture, meatal stenosis or bladder neck contracture, damaged external urinary sphincter, stress urinary incontinence, post-void residual >300 mL or urinary retention, or prior prostate surgery
- Men taking anticoagulants or on bladder anticholinergics or with severe cardiovascular disease
- PSA greater than 4.0 ng/ml (unless prostate cancer was ruled out by biopsy)
- Allergy to device materials, immune suppressants or corticosteroids use, and serious medical or mental illness.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Sung Yong Cho, M.D.,Ph.D., +82-2-870-2394, kmoretry@daum.net
About this study
Official title: Feasibility of Water Vaporization (Rezum®) for Patients With ≥ 30 and < 80 ml With Moderate-severe LUTS to Establish the Surgical Principles for Prominent or Non-prominent Median Lobe Enlargement: A Single-center, Prospective, Pilot Study
This study was created to determine the safety and efficacy of treating prostatic hyperplasia with or without prominent median lobe enlargement with the REZUM technique. The systematic implementation of decisions for the location, vapor time, and the number of injections contributes to the Rezum procedure configuration for the median lobe treatment being safer and standardizer.
- Conditions
- Prostatic Hyperplasia of the Medial Lobe
- Being tested
- Rezum®
- Keywords
- median lobe enlargement, lower urinary tract symptoms, International Prostate Symptoms Score
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezum®Device
Rezum® Water vaporization device
| Study group | Role | What they receive |
|---|---|---|
| Group A, 5 seconds | Experimental | Patients with benign prostatic hyperplasia featuring a small median lobe enlargement will be allocated to the 5-second Rezum therapy group. Receives: Device: Rezum® |
| Group B, 9 seconds | Experimental | Patients with benign prostatic hyperplasia featuring a big prominent median lobe enlargement will be allocated to the 9-second Rezum therapy group. Receives: Device: Rezum® |
What is being measured
The primary outcome is the main question the study is designed to answer.
age
patient's records
Measured: prior to procedure
Gender
patient's records
Measured: prior to procedure
height
meters
Measured: prior to procedure
weight
kilograms
Measured: prior to procedure
Medical history
patient's records
Measured: prior to procedure
Surgical history
patient's records
Measured: prior to procedure
Date of consent
patient's records
Measured: prior to procedure
Eastern Cooperative Oncology Group
0 Fully active, able to carry on all pre-disease performance without restriction
- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
- Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
- Dead
Measured: prior to procedure
complications
patient's records
Measured: prior to procedure
medications used at the time of pre-consent
patient's records
Measured: prior to procedure
drug allergies
patient's records
Measured: prior to procedure
prostate specific antigen
patient's records, ng/ml
Measured: prior to procedure, 3 month after surgery
Protein
Urinalysis, mg/dl
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
pH
Urinalysis
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
occult blood
Urinalysis, Negative or positive
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
white blood cell : Urinalysis
Urinalysis, Quantity
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
glucose
Urinalysis, mg/dl
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
red blood cell
Urinalysis, Quantity
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Bacteria
Urinalysis, Quantity
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Sodium
Blood tests, mEq/L
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Chloride
Blood tests, mEq/L
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
calcium
Blood tests, mg/dL
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Phosphorus
Blood tests, mg/dL
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
uric acid
Blood tests, mg/dl
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
blood urea nitrogen
Blood tests, mg/dl
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
creatinine
Blood tests, mg/dL
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
C-reactive protein
Blood tests, mg/dl
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
White blood cell : Blood tests
Blood tests, quantity
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Hemoglobin
Blood tests, g/dl
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Platelet
Blood tests, 10^3/μL
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Prostate specific antigen
Blood tests, ng/ml
Measured: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Prostate Ultrasound
patient's records
Measured: prior to procedure, 3 month after surgery
Uroflowmetry
patient's records, ml/sec
Measured: prior to procedure, 3 month after surgery
International Prostate Symptom Score
0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
Measured: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Incontinence Severity Index
Slight (1-2) Moderate (3-6) Severe (8-9) Very severe (12)
Measured: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Overactive Bladder Symptom Score
- How many times do you typically urinate from waking in the morning until sleeping at night?
7 or less 8 to 14 15 or more 2. How many times do you typically wake up to urinate from sleeping at night until waking in the morning?
0
1 2 3 or more 3. How often do you have a sudden desire to urinate, which is difficult to defer?
Not at All less than once a week once a week or more about once a day 2 to 4 times per day 5 times a day or more 4. How often do you leak urine, because you cannot defer the sudden desire to urinate?
Not at All less than once a week once a week or more about once a day 2 to 4 times per day 5 times a day or more
Measured: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Male Sexual Health for assessing ejaculatory dysfunction
- In the last month, without using drugs like Viagra, how often have you been able to get an erection when you wanted to? 5 All of the time 4 Most of the time 3 About half of the time 2 Less than half of the time 1 None of the time 0 Used Viagra or similar drug with every sexual encounter
- In the last month, if you were able to get an erection without using drugs like Viagra, how often were you able to stay hard as long as you wanted to? 5 All of the time 4 Most of the time 3 About half of the time 2 Less than half of the time 1 None of the time 0 Used Viagra or similar drug with every sexual encounter
- In the last month, if you were able to get an erection, without using drugs like Viagra, how would you rate the hardness of your erection? 5 Completely hard 4 Almost completely hard 3 Mostly hard, but can be slightly bent 2 A little hard, but bends easily 1 Not at all hard 0 Used Viagra or similar drug with every sexual encounter
Measured: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
International Index of Erectile Function
The IIEF-5 Questionnaire (SHIM)Score for Erectile Dysfunction1-7: Severe8-11: Moderate12-16: Mild-moderate17-21: Mild22-25: No Erectile Dysfunction Survey.
Measured: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
McGill Pain Questionnaire
The interpretation of the questionnaire is pretty basic: the higher the score, the higher the pain level. The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain.
Measured: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Brief Pain Inventory
Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Measured: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Treatment Satisfaction-Visual Analogue Scale
- No, not at all satisfied. 10. Yes, completely satisfied.
Measured: 1-2 weeks after injection, 3 month after surgery
Patient Global Impression of Improvement
Very much better 1 Much better 2 A little better 3 No change 4 A little worse 5 Much worse 6 Very much worse 7
Measured: 1-2 weeks after injection, 3 month after surgery
transrectal sonography of the prostate
Ultrasound examination
Measured: prior to procedure, 3 month after surgery
transrectal ultrasound
Ultrasound examination
Measured: prior to procedure
Postvoiding Residual
uroflowmetry
Measured: prior to procedure, 3 month after surgery
Post-surgery complications
patient's records
Measured: 1-2 weeks after injection, 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start3 Jun 2024 (estimated)
- Primary completion17 Jun 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Hyperplasia of the Medial LobeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yong Cho, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177821
- Sponsor's protocol ID
- REZUM
- Status last verified
- Apr 2024
- First submitted
- 30 Nov 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used during the current study are available from the corresponding author on request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Water Vaporization (Rezum®) for Patients With ≥ 30 and < 80 ml With Moderate-severe LUTS to Establish the Surgical Principles for Prominent or Non-prominent Median Lobe Enlargement: A Single-center, Prospective, Pilot Study
- ClinicalTrials.gov ID
- NCT06177821
- Acronym / sponsor ID
- REZUM
- Conditions
- Prostatic Hyperplasia of the Medial Lobe
- Keywords
- median lobe enlargement, lower urinary tract symptoms, International Prostate Symptoms Score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Jun 2024 (estimated)
- Primary completion
- 17 Jun 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Dec 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.
This study was created to determine the safety and efficacy of treating prostatic hyperplasia with or without prominent median lobe enlargement with the REZUM technique. The systematic implementation of decisions for the location, vapor time, and the number of injections contributes to the Rezum procedure configuration for the median lobe treatment being safer and standardizer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, 5 seconds | Experimental | Device: Rezum®Patients with benign prostatic hyperplasia featuring a small median lobe enlargement will be allocated to the 5-second Rezum therapy group. |
| Group B, 9 seconds | Experimental | Device: Rezum®Patients with benign prostatic hyperplasia featuring a big prominent median lobe enlargement will be allocated to the 9-second Rezum therapy group. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 50 to 85 years who have been diagnosed with benign prostatic hyperplasia at Seoul National University Hospital and are scheduled to undergo endoscopic surgery.
- benign prostatic hyperplasia ≥ 30 and < 80 ml
- Patients who have given written informed consent to participate in the study according to their age
- A urinary symptom score (International ProstateSymptom Score [IPSS] moderated (8-19 points) to severe (20-35 points)
- Measured Postvoiding Residual (PVR) <250 mL
Key exclusion criteria (6 listed)
- History of prostate or bladder cancer, neurogenic bladder, bladder calculus, or clinically significant bladder diverticulum
- Active infection, treatment for chronic prostatitis
- Diagnosis of urethral stricture, meatal stenosis or bladder neck contracture, damaged external urinary sphincter, stress urinary incontinence, post-void residual >300 mL or urinary retention, or prior prostate surgery
- Men taking anticoagulants or on bladder anticholinergics or with severe cardiovascular disease
- PSA greater than 4.0 ng/ml (unless prostate cancer was ruled out by biopsy)
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 |
|---|---|---|
| Rezum®Rezum® Water vaporization device | Device | Group A, 5 seconds, Group B, 9 seconds |
Primary outcome
age
Time frame: prior to procedure
patient's records
Gender
Time frame: prior to procedure
patient's records
height
Time frame: prior to procedure
meters
weight
Time frame: prior to procedure
kilograms
Medical history
Time frame: prior to procedure
patient's records
Surgical history
Time frame: prior to procedure
patient's records
Date of consent
Time frame: prior to procedure
patient's records
Eastern Cooperative Oncology Group
Time frame: prior to procedure
0 Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead
complications
Time frame: prior to procedure
patient's records
medications used at the time of pre-consent
Time frame: prior to procedure
patient's records
drug allergies
Time frame: prior to procedure
patient's records
prostate specific antigen
Time frame: prior to procedure, 3 month after surgery
patient's records, ng/ml
Protein
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, mg/dl
pH
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis
occult blood
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, Negative or positive
white blood cell : Urinalysis
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, Quantity
glucose
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, mg/dl
red blood cell
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, Quantity
Bacteria
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, Quantity
Sodium
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mEq/L
Chloride
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mEq/L
calcium
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dL
Phosphorus
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dL
uric acid
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dl
blood urea nitrogen
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dl
creatinine
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dL
C-reactive protein
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dl
White blood cell : Blood tests
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, quantity
Hemoglobin
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, g/dl
Platelet
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, 10^3/μL
Prostate specific antigen
Time frame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, ng/ml
Prostate Ultrasound
Time frame: prior to procedure, 3 month after surgery
patient's records
Uroflowmetry
Time frame: prior to procedure, 3 month after surgery
patient's records, ml/sec
International Prostate Symptom Score
Time frame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
Incontinence Severity Index
Time frame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Slight (1-2) Moderate (3-6) Severe (8-9) Very severe (12)
Overactive Bladder Symptom Score
Time frame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
1. How many times do you typically urinate from waking in the morning until sleeping at night? 7 or less 8 to 14 15 or more 2. How many times do you typically wake up to urinate from sleeping at night until waking in the morning? 0 1 2 3 or more 3. How often do you have a sudden desire to urinate, which is difficult to defer? Not at All less than once a week once a week or more about once a day 2 to 4 times per day 5 times a day or more 4. How often do you leak urine, because you cannot defer the sudden desire to urinate? Not at All less than once a week once a week or more about once a day 2 to 4 times per day 5 times a day or more
Male Sexual Health for assessing ejaculatory dysfunction
Time frame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
1. In the last month, without using drugs like Viagra, how often have you been able to get an erection when you wanted to? 5 All of the time 4 Most of the time 3 About half of the time 2 Less than half of the time 1 None of the time 0 Used Viagra or similar drug with every sexual encounter 2. In the last month, if you were able to get an erection without using drugs like Viagra, how often were you able to stay hard as long as you wanted to? 5 All of the time 4 Most of the time 3 About half of the time 2 Less than half of the time 1 None of the time 0 Used Viagra or similar drug with every sexual encounter 3. In the last month, if you were able to get an erection, without using drugs like Viagra, how would you rate the hardness of your erection? 5 Completely hard 4 Almost completely hard 3 Mostly hard, but can be slightly bent 2 A little hard, but bends easily 1 Not at all hard 0 Used Viagra or similar drug with every sexual encounter
International Index of Erectile Function
Time frame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
The IIEF-5 Questionnaire (SHIM)Score for Erectile Dysfunction1-7: Severe8-11: Moderate12-16: Mild-moderate17-21: Mild22-25: No Erectile Dysfunction Survey.
McGill Pain Questionnaire
Time frame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
The interpretation of the questionnaire is pretty basic: the higher the score, the higher the pain level. The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain.
Brief Pain Inventory
Time frame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Treatment Satisfaction-Visual Analogue Scale
Time frame: 1-2 weeks after injection, 3 month after surgery
0. No, not at all satisfied. 10. Yes, completely satisfied.
Patient Global Impression of Improvement
Time frame: 1-2 weeks after injection, 3 month after surgery
Very much better 1 Much better 2 A little better 3 No change 4 A little worse 5 Much worse 6 Very much worse 7
transrectal sonography of the prostate
Time frame: prior to procedure, 3 month after surgery
Ultrasound examination
transrectal ultrasound
Time frame: prior to procedure
Ultrasound examination
Postvoiding Residual
Time frame: prior to procedure, 3 month after surgery
uroflowmetry
Post-surgery complications
Time frame: 1-2 weeks after injection, 3 month after surgery
patient's records
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No. The datasets used during the current study are available from the corresponding author on request.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rezum® in people with Prostatic Hyperplasia of the Medial Lobe, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
age (time frame: prior to procedure). The study lists 46 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 19 Apr 2024.