Erectile DysfunctionNCT06350019
Vascular Effects of Penil revascularızatıon
A study testing Penile revascularızation in people with Erectile Dysfunction and Erectile Dysfunction Due to Arterial Disease, run by Ankara Yildirim Beyazıt University.
Trial summary
Purpose: The aim of this study is to measure the effects of penile revascularization surgery performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to determine the importance of vascular parameters in postoperative patient follow-up. Read more about this study
- Who is it for?
- Ages 23 to 69 years, men only
- Conditions the study is for
- Erectile Dysfunction, Erectile Dysfunction Due to Arterial Disease, Erectile Dysfunction Due to Venous Disorder
- What is being tested?
- Penile revascularızation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 25 Dec 2014
- 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 23 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases that do not benefit from oral phosphodiesterase 5 inhibitor or intracavernosal injection treatment
- Cases with PSV<25 cm/s in PCDU
- Cases with PSV>25 cm/s, EDV>5 cm/s and RI<0.85 in PCDU
- Patients with relaxation degree above 50% in CC-EMG
- Cases with venous leakage in cavernosometry
Who cannot join
- hypogonadism (primer or secondary),
- Cases benefiting from phosphodiesterase 5 inhibitors
- Cases benefiting from intracavernous alprostadil
- Those with a history of urogenital, rectal and similar operations
- Those with Peyronie's disease
- Cases of neurogenic and psychogenic origin
About this study
Official title: Vascular hemodynamıc Effects of penılle revascularızatıon Surgery and the Role of resıstıve ındex ın Follow-up
Purpose: The aim of this study is to measure the effects of penile revascularization surgery performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to determine the importance of vascular parameters in postoperative patient follow-up.
Methods: A total of 35 participants who underwent penile revascularization surgery due to vascular ED were included in this study. In the preoperative period and at the 3rd postoperative month, penile color doppler ultrasonography (PCDU) was performed to evaluate cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery (IEA) separately. During this evaluation, peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) were measured. The International Index of Erectile Function questionnaire (IIEF) was applied to all patients in the preoperative period and at the 3rd postoperative month. The relationship between changes in (IIEF) questionnaire score and penile vascular hemodynamic changes in the postoperative period was evaluated.
Read the detailed description
A total of 35 participants who underwent penile revascularization surgery with the diagnosis of vascular ED in our clinic were included in this study. Detailed anamnesis of the cases was taken, including age, duration of ED, comorbidities that may cause ED, previous trauma, medical or surgical history and lifestyle. After the physical examination, IIEF 5/15 questionnaires were filled out. In order to exclude hypogonadism, follicle stimulating hormone(FSH), luteinizing hormone(LH), total testosterone and prolactin levels were measured in the preoperative period. PCDU, CC-EMG and cavernosometry tests were applied to all participants in the preoperative period. Participants that did not benefit from phosphodiesterase 5 inhibitors(PDE-5I) and intracavernosal alprostadil injection used in the preoperative period were included in the study. Cases with a history of urogenital, rectal and similar operations that may affect erectile functions, cases with penile pathologies such as Peyronie's disease, and cases with ED of neurogenic and psychogenic origin were excluded from this study. After the 3rd postoperative month, participants were interviewed face to face. During these follow up, the patients were re-evaluated with the IIEF-5/15 questionnaires, and PCDU and computurized tomography angiography (CTA) was performed.
PCDU technique: The PCDU was performed in a quiet and comfortable room for the participants' comfort. For the diagnosis of arterial insufficiency or veno-occlusive disease, PCDU(B-K Medical, Herlev, Denmark) was performed with the patient lying in the supine position. First, gray scale imaging of the flaccid penil shaft in transverse and sagittal planes was performed to exclude intracavernosal fibrosis and calcifications. Then, 60 mg papaverine hydrochloride (Papaverine HCl®, Galen Medical Industry, Turkey) was injected laterally into any of the corpus cavernosum with a 22 Gauge needle. 20 minutes after papaverine HCl injection, PCDU was performed with an 8 Megahertz (MHz) linear probe at an angle of approximately 45 degrees. PSV, EDV, RI values of both cavernosal arteries and anastomosis region were calculated. Measurements were repeated at 5-minute intervals and continued for 30 minutes. Participants with PSV<25 cantimeters/second (cm/s) were interpreted as arterial insufficiency, and participants with PSV>25 cm/s, EDV >5 cm/s and RI<0.85 were interpreted as veno-occlusive disease. RI was calculated with the formula [RI=(PSV-EDV)/PSV]. Participants were warned about the risk of priapism after papaverine HCl injection and were asked to immediately consult the clinic if the erection persisted after four hours.
CC-EMG technique: Penil cavernous electrical activity (CEA) was recorded using a high-speed electromyography module equipped with a computer (Medical Measurement Systems, Enschede, the Netherlands). The sampling frequency was 200 Hertz (Hz), and a band-pass filter with a cut-off frequency of 0.1-20 Hz was used. During the CC-EMG recordings, monopolar needle electrode was used to measure the CEA. A grounding electrode was placed to the participants' foot to avoid electrical activity simultaneously originating from non-penil areas. It appears as a single line in the CC-EMG recording. CC-EMG recordings were started after the participants rested for 10 minutes in a quiet and dim room. CEA potentials were recorded for 10 minutes. Later the CEA potentials of the penil cavernous nerves was assessed by detecting the peak-to-peak amplitudes. Ten minutes later, papaverine HCl (60 mg) was injected into a single cavernous body for avoiding the pattern of discoordination, which manifested by an increase or no difference in the CEA recording following the injection and suggested the neurogenic ED. Participants with a discoordination pattern were not included in the study. The relaxation degree (RD) was calculated using the formula: RD=Pre-injection CEA-Post-injection CEA/Preinjection CEA×100, as previously described. Participants having less than 50% RD were excluded from the study.
Cavernosometry technique: After CC-EMG recordings were made, cavernosometry was conducted with the same device. In the presence of the following criteria, a diagnosis of caverno-occlusive dysfunction was made.
- Requires a maintenance flow rate greater than 5 milliliters/minute (ml/m) after revealed an intracavernous pressure of 150 millimeters-Hg (mmHg) with the artificial erection test.
- The intracavernous pressure decreased by a minimum of 45 mmHg within 30 second following the termination of infusion.
Surgical technique: The operations, were conducted using the Furlow-Fisher procedur, of the Virag-V technique. Unlike the Furlow- Fisher procedure, the circumflex collaterals were preserved, and the deep dorsal venous valves were not disrupted by a stripper. After the IEA was brought to the penil root through the subcutaneous tunnel, an end-to-side anastomosis was performed with the proximal part of the deep dorsal vein. 7-0 polypropylene suture were used according to a standard microsurgical procedure. After the anastomosis, the deep dorsal vein was ligated proximal to the arteriovenous anastomosis. The procedure was performed under optical magnification (x2.5) to prevent neurovascular bundle damage. In the postoperative period, intravenous heparin (5000 IU/day) was prescribed for 3 days, 75 mg/day dipyridamole and 300 mg/day acetylsalicylic acid daily for three months. He was warned not to have sexual intercourse for 2 months after the operation.
CTA technique: In the third postoperative month, participants underwent CTA. 60 milligram (mg) papaverine HCl was administered to the subjects 10 minutes before the shooting. A 22-gauge branule was placed in the basilic or cephalic vein of the patient's forearm. Then, the patient was placed supine on the imaging stretcher and the area to be imaged was determined. Then, using an automatic injector pump, iodinated contrast material(Iopromide, Ultravist®, Schering, Germany) was given to the patient intravenously at a dose of 2 mg/kg and at a flow rate of 3 ml/s. Then, arterial phase pelvic CTA with 2 mm slice thickness was performed with a 64-detector, multi detector CT machine (Aquilion 64, Toshiba®, Tokyo, Japan). After CTA examination, sagittal and coronal reformatted images(slice thickness: 1 mm) were obtained. CT images were evaluated by an experienced radiologist.
- Conditions
- Erectile Dysfunction, Erectile Dysfunction Due to Arterial Disease, Erectile Dysfunction Due to Venous Disorder
- Being tested
- Penile revascularızation
- Keywords
- Erectile dysfunction, Penile revascularization, Penile color doppler ultrasonography, Resistive index
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile revascularızationProcedure or surgery
The importance of resistive index in the preoperative evaluation of vascular-induced erectile dysfunction, predicting the success of penile revascularization surgery, and postoperative patient management was investigated.
| Study group | Role | What they receive |
|---|---|---|
| Cases with erectile dysfunction of vascular origin | Experimental | Penile revascularization surgery was performed in cases with erectile dysfunction of vascular origin. Penile color Doppler ultrasonography, corpus cavernosum electromyography and cavernosometry tests were performed on all cases in the preoperative period and at the 3rd postoperative month. Penile computed tomography angiography was performed at the 3rd postoperative month. Receives: Procedure: Penile revascularızation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The importance of resistive index in evaluating the postoperative success of penile revascularization
Penile revascularization was performed in 35 cases with the diagnosis of erectile dysfunction of vascular origin. Both preoperative and postoperative international index of erectile function questionaire (IIEF) and penile color Doppler ultrasound (PCDU) were performed in all cases, and IIEF 5/15 scores and resistive index (RI) were calculated. After the operation, computerized tomography angiography (CTA) was performed to confirm anastomotic patency. The correlation between RI and IIEF was evaluated in the postoperative period. RI = 0.85 was accepted as the limit value to evaluate postoperative success. Cases with RI>0.85 were considered successful and cases with RI<0.85 were considered unsuccessful.
Measured: 3 months (Postoperative third months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jan 2013
- Primary completion15 Aug 2014
- Study completion25 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Akdemir, Ankara Yildirim Beyazıt University
- Investigators
- Fatih AKDEMİR, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350019
- Sponsor's protocol ID
- 26379996/91
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available
Publications
Akdemir F, Kayigil O. Vascular hemodynamic effects of penile revascularization surgery and the role of resistive index in follow-up. Basic Clin Androl. 2024 Dec 20;34(1):28. doi: 10.1186/s12610-024-00243-0.
PubMed 39701967
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular hemodynamıc Effects of penılle revascularızatıon Surgery and the Role of resıstıve ındex ın Follow-up
- ClinicalTrials.gov ID
- NCT06350019
- Acronym / sponsor ID
- 26379996/91
- Conditions
- Erectile Dysfunction, Erectile Dysfunction Due to Arterial Disease, Erectile Dysfunction Due to Venous Disorder
- Keywords
- Erectile dysfunction, Penile revascularization, Penile color doppler ultrasonography, Resistive index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 15 Aug 2014 (actual)
- Study completion
- 25 Dec 2014 (actual)
- First posted
- 5 Apr 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.
Purpose: The aim of this study is to measure the effects of penile revascularization surgery performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to determine the importance of vascular parameters in postoperative patient follow-up.
Methods: A total of 35 participants who underwent penile revascularization surgery due to vascular ED were included in this study. In the preoperative period and at the 3rd postoperative month, penile color doppler ultrasonography (PCDU) was performed to evaluate cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery (IEA) separately. During this evaluation, peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) were measured. The International Index of Erectile Function questionnaire (IIEF) was applied to all patients in the preoperative period and at the 3rd postoperative month. The relationship between changes in (IIEF) questionnaire score and penile vascular hemodynamic changes in the postoperative period was evaluated.
Detailed description
A total of 35 participants who underwent penile revascularization surgery with the diagnosis of vascular ED in our clinic were included in this study. Detailed anamnesis of the cases was taken, including age, duration of ED, comorbidities that may cause ED, previous trauma, medical or surgical history and lifestyle. After the physical examination, IIEF 5/15 questionnaires were filled out. In order to exclude hypogonadism, follicle stimulating hormone(FSH), luteinizing hormone(LH), total testosterone and prolactin levels were measured in the preoperative period. PCDU, CC-EMG and cavernosometry tests were applied to all participants in the preoperative period. Participants that did not benefit from phosphodiesterase 5 inhibitors(PDE-5I) and intracavernosal alprostadil injection used in the preoperative period were included in the study. Cases with a history of urogenital, rectal and similar operations that may affect erectile functions, cases with penile pathologies such as Peyronie's disease, and cases with ED of neurogenic and psychogenic origin were excluded from this study. After the 3rd postoperative month, participants were interviewed face to face. During these follow up, the patients were re-evaluated with the IIEF-5/15 questionnaires, and PCDU and computurized tomography angiography (CTA) was performed.
PCDU technique: The PCDU was performed in a quiet and comfortable room for the participants' comfort. For the diagnosis of arterial insufficiency or veno-occlusive disease, PCDU(B-K Medical, Herlev, Denmark) was performed with the patient lying in the supine position. First, gray scale imaging of the flaccid penil shaft in transverse and sagittal planes was performed to exclude intracavernosal fibrosis and calcifications. Then, 60 mg papaverine hydrochloride (Papaverine HCl®, Galen Medical Industry, Turkey) was injected laterally into any of the corpus cavernosum with a 22 Gauge needle. 20 minutes after papaverine HCl injection, PCDU was performed with an 8 Megahertz (MHz) linear probe at an angle of approximately 45 degrees. PSV, EDV, RI values of both cavernosal arteries and anastomosis region were calculated. Measurements were repeated at 5-minute intervals and continued for 30 minutes. Participants with PSV<25 cantimeters/second (cm/s) were interpreted as arterial insufficiency, and participants with PSV>25 cm/s, EDV >5 cm/s and RI<0.85 were interpreted as veno-occlusive disease. RI was calculated with the formula [RI=(PSV-EDV)/PSV]. Participants were warned about the risk of priapism after papaverine HCl injection and were asked to immediately consult the clinic if the erection persisted after four hours.
CC-EMG technique: Penil cavernous electrical activity (CEA) was recorded using a high-speed electromyography module equipped with a computer (Medical Measurement Systems, Enschede, the Netherlands). The sampling frequency was 200 Hertz (Hz), and a band-pass filter with a cut-off frequency of 0.1-20 Hz was used. During the CC-EMG recordings, monopolar needle electrode was used to measure the CEA. A grounding electrode was placed to the participants' foot to avoid electrical activity simultaneously originating from non-penil areas. It appears as a single line in the CC-EMG recording. CC-EMG recordings were started after the participants rested for 10 minutes in a quiet and dim room. CEA potentials were recorded for 10 minutes. Later the CEA potentials of the penil cavernous nerves was assessed by detecting the peak-to-peak amplitudes. Ten minutes later, papaverine HCl (60 mg) was injected into a single cavernous body for avoiding the pattern of discoordination, which manifested by an increase or no difference in the CEA recording following the injection and suggested the neurogenic ED. Participants with a discoordination pattern were not included in the study. The relaxation degree (RD) was calculated using the formula: RD=Pre-injection CEA-Post-injection CEA/Preinjection CEA×100, as previously described. Participants having less than 50% RD were excluded from the study.
Cavernosometry technique: After CC-EMG recordings were made, cavernosometry was conducted with the same device. In the presence of the following criteria, a diagnosis of caverno-occlusive dysfunction was made.
- Requires a maintenance flow rate greater than 5 milliliters/minute (ml/m) after revealed an intracavernous pressure of 150 millimeters-Hg (mmHg) with the artificial erection test.
- The intracavernous pressure decreased by a minimum of 45 mmHg within 30 second following the termination of infusion.
Surgical technique: The operations, were conducted using the Furlow-Fisher procedur, of the Virag-V technique. Unlike the Furlow- Fisher procedure, the circumflex collaterals were preserved, and the deep dorsal venous valves were not disrupted by a stripper. After the IEA was brought to the penil root through the subcutaneous tunnel, an end-to-side anastomosis was performed with the proximal part of the deep dorsal vein. 7-0 polypropylene suture were used according to a standard microsurgical procedure. After the anastomosis, the deep dorsal vein was ligated proximal to the arteriovenous anastomosis. The procedure was performed under optical magnification (x2.5) to prevent neurovascular bundle damage. In the postoperative period, intravenous heparin (5000 IU/day) was prescribed for 3 days, 75 mg/day dipyridamole and 300 mg/day acetylsalicylic acid daily for three months. He was warned not to have sexual intercourse for 2 months after the operation.
CTA technique: In the third postoperative month, participants underwent CTA. 60 milligram (mg) papaverine HCl was administered to the subjects 10 minutes before the shooting. A 22-gauge branule was placed in the basilic or cephalic vein of the patient's forearm. Then, the patient was placed supine on the imaging stretcher and the area to be imaged was determined. Then, using an automatic injector pump, iodinated contrast material(Iopromide, Ultravist®, Schering, Germany) was given to the patient intravenously at a dose of 2 mg/kg and at a flow rate of 3 ml/s. Then, arterial phase pelvic CTA with 2 mm slice thickness was performed with a 64-detector, multi detector CT machine (Aquilion 64, Toshiba®, Tokyo, Japan). After CTA examination, sagittal and coronal reformatted images(slice thickness: 1 mm) were obtained. CT images were evaluated by an experienced radiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases with erectile dysfunction of vascular origin | Experimental | Procedure: Penile revascularızationPenile revascularization surgery was performed in cases with erectile dysfunction of vascular origin. Penile color Doppler ultrasonography, corpus cavernosum electromyography and cavernosometry tests were performed on all cases in the preoperative period and at the 3rd postoperative month. Penile computed tomography angiography was performed at the 3rd postoperative month. |
Who may qualify
- Ages
- 23 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cases that do not benefit from oral phosphodiesterase 5 inhibitor or intracavernosal injection treatment
- Cases with PSV<25 cm/s in PCDU
- Cases with PSV>25 cm/s, EDV>5 cm/s and RI<0.85 in PCDU
- Patients with relaxation degree above 50% in CC-EMG
- Cases with venous leakage in cavernosometry
Key exclusion criteria (6 listed)
- hypogonadism (primer or secondary),
- Cases benefiting from phosphodiesterase 5 inhibitors
- Cases benefiting from intracavernous alprostadil
- Those with a history of urogenital, rectal and similar operations
- Those with Peyronie's disease
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 |
|---|---|---|
| Penile revascularızationThe importance of resistive index in the preoperative evaluation of vascular-induced erectile dysfunction, predicting the success of penile revascularization surgery, and postoperative patient management was investigated. | Procedure or surgery | Cases with erectile dysfunction of vascular origin |
Primary outcome
The importance of resistive index in evaluating the postoperative success of penile revascularization
Time frame: 3 months (Postoperative third months)
Penile revascularization was performed in 35 cases with the diagnosis of erectile dysfunction of vascular origin. Both preoperative and postoperative international index of erectile function questionaire (IIEF) and penile color Doppler ultrasound (PCDU) were performed in all cases, and IIEF 5/15 scores and resistive index (RI) were calculated. After the operation, computerized tomography angiography (CTA) was performed to confirm anastomotic patency. The correlation between RI and IIEF was evaluated in the postoperative period. RI = 0.85 was accepted as the limit value to evaluate postoperative success. Cases with RI>0.85 were considered successful and cases with RI<0.85 were considered unsuccessful.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 39701967Akdemir F, Kayigil O. Vascular hemodynamic effects of penile revascularization surgery and the role of resistive index in follow-up. Basic Clin Androl. 2024 Dec 20;34(1):28. doi: 10.1186/s12610-024-00243-0.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available
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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.
Fatih AKDEMİR principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Penile revascularızation in people with Erectile Dysfunction and Erectile Dysfunction Due to Arterial Disease, run by Ankara Yildirim Beyazıt University.
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: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The importance of resistive index in evaluating the postoperative success of penile revascularization (time frame: 3 months (Postoperative third months)). 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 NCT06350019, which also lists 1 linked publication.
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 Apr 2024.