MastectomyNCT06538818
Ultra Phonophoresis With a Hyaluronic Acid-Containing Gel on Carpal Tunnel Syndrome Post Mastectomy.
A study testing Ultra Phonophoresis in people with Mastectomy and Carpal Tunnel Syndrome (CTS), run by Cairo University at 1 site in Egypt.
Trial summary
In this study, 60 patients will be randomly assigned into two equal groups (30 patients for each group): 1. Group A: This group will include 30 patients who will receive Ultra Phonophoresis with a hyaluronic acid-containing gel 5 sessions per week for 3 weeks in addition to their physical therapy program and medical… Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Mastectomy, Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Ultra Phonophoresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Nov 2024
- 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age range between 40-55 years.
- Female patients will participate in the study.
- All patients will have hormonal therapy at least for 6 weeks.
- All patients enrolled to the study will have their informed consent.
- Patient referred from physician by carpal tunnel syndrome
Who cannot join
- -Marked lymphedema.
- Steroid injection for CTS.
- Thrombosis propensity.
- Cervical radiculopathy.
- Brachial plexopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra Phonophoresis With a Hyaluronic Acid-Containing Gel on Carpal Tunnel Syndrome Related Hormonal Therapy Post Mastectomy.
In this study, 60 patients will be randomly assigned into two equal groups (30 patients for each group):
- Group A: This group will include 30 patients who will receive Ultra Phonophoresis with a hyaluronic acid-containing gel 5 sessions per week for 3 weeks in addition to their physical therapy program and medical treatment.
- Group B: This group will include 30 patients who will receive only their traditional physical therapy program and medical treatment.
Read more
Criteria for the patient selection:
(A) Inclusion Criteria:
The subject selection will be according to the following criteria:
- Age range between 40-55 years.
- Female patients will participate in the study.
- All patients will have hormonal therapy at least for 6 weeks.
- All patients enrolled to the study will have their informed consent.
- Patient referred from physician by carpal tunnel syndrome. (B) Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
- Marked lymphedema.
- Steroid injection for CTS.
- Thrombosis propensity.
- Cervical radiculopathy.
- Brachial plexopathy
Read the detailed description
- Assessment measures and procedures: The outcome measures will include Median nerve sensory and motor distal latency, arm volume calculated by circumference measurement, pain using a visual analogue scale (VAS) and Boston Carpal Tunnel Questionnaire (BCTQ). Assessment will conducted by a physiotherapist pre-and post-treatment.
- Nerve conduction studies: Electro diagnostic assessment will conducted by a physical medicine specialist. During the study, the temperature of patients' hands will be kept >32. For assessing the Motor distal latency, the active recording electrode will be fastened on abductor pollicis brevis (APB) muscle and median nerve will be stimulated at wrist region with stimulator electrode, 8 cm proximal to the active electrode and then the distal latency will be recorded. Regarding the sensory distal latency, the recorder will be fastened on the third finger, and stimulator electrode will be placed 14 cm proximal to the recorder and will stimulate median nerve once at wrist and once at palm region, then distal latency will be recorded. Normal distal sensory latency of median nerve is of less than 3.6 and distal motor latency of median nerve less than 4.2. If only the sensory distal latency will long, patient has mild CTS, but if both sensory and motor distal latency will be long and denervation will not be observed in electromyography of APB, it is moderate CTS.
- Visual analogue scale VAS for pain assessment: Intensity of pain is another outcome measure will be used to evaluate treatment. Adults use the visual analogue scale (VAS), a one-dimensional assessment tool, particularly for chronic pain. The VAS is a continuous scale that consists of a line that is either vertical (VVAS) or horizontal (HVAS), usually 10 cm long, and is supported by two verbal descriptors, one for each symptom intensity. The patients will be thoroughly briefed on the instructions, reporting timeline, and vocal description anchors prior to the measurement.
- Baseline hand dynamometer Baseline hydraulic hand dynamometer is used to measure hand grip strength. It is manufactured and serviced in the USA since 1978. It gives accurate grip strength readings without the subject being able to feel the handle move. The internationally accepted design ensures reliability, user convenience and measurement repeatability. Maximum reading remains until the unit is reset. The device comes with five position handles to improve comfort while using the dynamometer. The device Gauge is made of bourdon tube element with spring suspended movement that can viewed as pounds or kilograms.
- Boston Carpal Tunnel Questionnaire (BCTQ): Patients w Patients with CTS can assess their level of dysfunction and symptom severity using the BCTQ .It has two measurement scales: the BCTQ-F, which measures functional status, and the BCTQ-S, which measures symptom severity. The BCTQ-S employs eleven questions on a five-point rating system from 1 (no symptoms) to 5 (severe symptoms) to assess the frequency and intensity of pain, numbness, weakness, and loss of dexterity. The average scores of the 11 questions are used to analyze the results. The BCTQ-F has eight questions that are scored on a five-point scale from 1 (no trouble) to 5 (cannot do at all owing to hand or wrist symptoms) to assess the degree of difficulty in carrying out daily chores. The average scores of the eight questions are used to analyze the results. 2-2- 50 - 100 b-Therapeutic device: a.Ultrasound device + Gel pad Phyactio n For ultrasound therapy offers a large and clear screen, with a user-friendly interface that makes it simple and easy to use. The device comes with a multi-frequency detachable head (1 / 3 MHZ and offers different pulsed and continuous modes (10 -25 - 30 - 40 - 50 - 100%). Device specifications:
- -Dimensions: 265 x 275 x 122 mm
- -Weight: 3.1 Kg
- -Mains voltage: 100 - 240 VAC, 50/60 HZ
- -Maximum power: 35 VA
- -Safety class: Class I
- -Treatment time: 0-30 minutes
- Procedures of Ultra Phonophoresis; Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of a hyaluronic acid-containing gel will be applied gel pad over the wrist and along the course of median nerve at the carpal tunnel.
The following parameters will be used: intensity of 1.0 W/em2 at a 1MHz frequency for 5 minutes and pulsed (25%) ultrasound waves to transfer the hyaluronic acid-containing gel. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks.
The following parameters will be used:
- intensity of 1.0 W/cm2
- 1MHz frequency
- pulsed (25%)
- 5 min/session, 5 d/wk, for 3 weeks.
- Conditions
- Mastectomy, Carpal Tunnel Syndrome (CTS)
- Being tested
- Ultra Phonophoresis
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra PhonophoresisDevice
Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of a hyaluronic acid-containing gel will be applied gel pad over the wrist and along the course of median nerve at the carpal tunnel.
The following parameters will be used: intensity of 1.0 W/em2 at a 1MHz frequency for 5 minutes and pulsed (25%) ultrasound waves to transfer the hyaluronic acid-containing gel. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks.
The following parameters will be used:
- intensity of 1.0 W/cm2
- 1MHz frequency
- pulsed (25%)
- 5 min/session, 5 d/wk, for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | This group will include 30 patients who will receive Ultra Phonophoresis with a hyaluronic acid-containing gel 5 sessions per week for 3 weeks in addition to their physical therapy program and medical treatment. Receives: Device: Ultra Phonophoresis |
| Control group: | No intervention | This group will include 30 patients who will receive only their traditional physical therapy program and medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median nerve sensory and motor distal latency
For assessing the Motor distal latency, the active recording electrode will be fastened on abductor pollicis brevis (APB) muscle and median nerve will be stimulated at wrist region with stimulator electrode, 8 cm proximal to the active electrode and then the distal latency will be recorded. Regarding the sensory distal latency, the recorder will be fastened on the third finger, and stimulator electrode will be placed 14 cm proximal to the recorder and will stimulate median nerve once at wrist and once at palm region, then distal latency will be recorded. Normal distal sensory latency of median nerve is of less than 3.6 and distal motor latency of median nerve less than 4.2. If only the sensory distal latency will long, patient has mild CTS, but if both sensory and motor distal latency will be long and denervation will not be observed in electromyography of APB, it is moderate CTS.
Measured: 3 weeks
pain using a visual analogue scale (VAS)
Intensity of pain is another outcome measure will be used to evaluate treatment. Adults use the visual analogue scale (VAS), a one-dimensional assessment tool, particularly for chronic pain. The VAS is a continuous scale that consists of a line that is either vertical (VVAS) or horizontal (HVAS), usually 10 cm long, and is supported by two verbal descriptors, one for each symptom intensity. The patients will be thoroughly briefed on the instructions, reporting timeline, and vocal description anchors prior to the measurement.
Measured: 3 weeks
Baseline hydraulic hand dynamometer is used to measure hand grip strength
. It is manufactured and serviced in the USA since 1978. It gives accurate grip strength readings without the subject being able to feel the handle move.
The internationally accepted design ensures reliability, user convenience and measurement repeatability. Maximum reading remains until the unit is reset. The device comes with five position handles to improve comfort while using the dynamometer. The device Gauge is made of bourdon tube element with spring suspended movement that can viewed as pounds or kilograms.
Measured: 3 weeks
Boston Carpal Tunnel Questionnaire (BCTQ):
Patients with CTS can assess their level of dysfunction and symptom severity using the BCTQ .It has two measurement scales: the BCTQ-F, which measures functional status, and the BCTQ-S, which measures symptom severity. The BCTQ-S employs eleven questions on a five-point rating system from 1 (no symptoms) to 5 (severe symptoms) to assess the frequency and intensity of pain, numbness, weakness, and loss of dexterity. The average scores of the 11 questions are used to analyze the results. The BCTQ-F has eight questions that are scored on a five-point scale from 1 (no trouble) to 5 (cannot do at all owing to hand or wrist symptoms) to assess the degree of difficulty in carrying out daily chores. The average scores of the eight questions are used to analyze the results.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Fawzy El-Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538818
- Sponsor's protocol ID
- P.T.REC/012/005219
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Phonophoresis With a Hyaluronic Acid-Containing Gel on Carpal Tunnel Syndrome Related Hormonal Therapy Post Mastectomy.
- ClinicalTrials.gov ID
- NCT06538818
- Acronym / sponsor ID
- P.T.REC/012/005219
- Conditions
- Mastectomy, Carpal Tunnel Syndrome (CTS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 6 Aug 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.
In this study, 60 patients will be randomly assigned into two equal groups (30 patients for each group):
- Group A: This group will include 30 patients who will receive Ultra Phonophoresis with a hyaluronic acid-containing gel 5 sessions per week for 3 weeks in addition to their physical therapy program and medical treatment.
- Group B: This group will include 30 patients who will receive only their traditional physical therapy program and medical treatment.
Criteria for the patient selection:
(A) Inclusion Criteria:
The subject selection will be according to the following criteria:
- Age range between 40-55 years.
- Female patients will participate in the study.
- All patients will have hormonal therapy at least for 6 weeks.
- All patients enrolled to the study will have their informed consent.
- Patient referred from physician by carpal tunnel syndrome. (B) Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
- Marked lymphedema.
- Steroid injection for CTS.
- Thrombosis propensity.
- Cervical radiculopathy.
- Brachial plexopathy
Detailed description
- Assessment measures and procedures: The outcome measures will include Median nerve sensory and motor distal latency, arm volume calculated by circumference measurement, pain using a visual analogue scale (VAS) and Boston Carpal Tunnel Questionnaire (BCTQ). Assessment will conducted by a physiotherapist pre-and post-treatment.
- Nerve conduction studies: Electro diagnostic assessment will conducted by a physical medicine specialist. During the study, the temperature of patients' hands will be kept >32. For assessing the Motor distal latency, the active recording electrode will be fastened on abductor pollicis brevis (APB) muscle and median nerve will be stimulated at wrist region with stimulator electrode, 8 cm proximal to the active electrode and then the distal latency will be recorded. Regarding the sensory distal latency, the recorder will be fastened on the third finger, and stimulator electrode will be placed 14 cm proximal to the recorder and will stimulate median nerve once at wrist and once at palm region, then distal latency will be recorded. Normal distal sensory latency of median nerve is of less than 3.6 and distal motor latency of median nerve less than 4.2. If only the sensory distal latency will long, patient has mild CTS, but if both sensory and motor distal latency will be long and denervation will not be observed in electromyography of APB, it is moderate CTS.
- Visual analogue scale VAS for pain assessment: Intensity of pain is another outcome measure will be used to evaluate treatment. Adults use the visual analogue scale (VAS), a one-dimensional assessment tool, particularly for chronic pain. The VAS is a continuous scale that consists of a line that is either vertical (VVAS) or horizontal (HVAS), usually 10 cm long, and is supported by two verbal descriptors, one for each symptom intensity. The patients will be thoroughly briefed on the instructions, reporting timeline, and vocal description anchors prior to the measurement.
- Baseline hand dynamometer Baseline hydraulic hand dynamometer is used to measure hand grip strength. It is manufactured and serviced in the USA since 1978. It gives accurate grip strength readings without the subject being able to feel the handle move. The internationally accepted design ensures reliability, user convenience and measurement repeatability. Maximum reading remains until the unit is reset. The device comes with five position handles to improve comfort while using the dynamometer. The device Gauge is made of bourdon tube element with spring suspended movement that can viewed as pounds or kilograms.
- Boston Carpal Tunnel Questionnaire (BCTQ): Patients w Patients with CTS can assess their level of dysfunction and symptom severity using the BCTQ .It has two measurement scales: the BCTQ-F, which measures functional status, and the BCTQ-S, which measures symptom severity. The BCTQ-S employs eleven questions on a five-point rating system from 1 (no symptoms) to 5 (severe symptoms) to assess the frequency and intensity of pain, numbness, weakness, and loss of dexterity. The average scores of the 11 questions are used to analyze the results. The BCTQ-F has eight questions that are scored on a five-point scale from 1 (no trouble) to 5 (cannot do at all owing to hand or wrist symptoms) to assess the degree of difficulty in carrying out daily chores. The average scores of the eight questions are used to analyze the results. 2-2- 50 - 100 b-Therapeutic device: a.Ultrasound device + Gel pad Phyactio n For ultrasound therapy offers a large and clear screen, with a user-friendly interface that makes it simple and easy to use. The device comes with a multi-frequency detachable head (1 / 3 MHZ and offers different pulsed and continuous modes (10 -25 - 30 - 40 - 50 - 100%). Device specifications:
- -Dimensions: 265 x 275 x 122 mm
- -Weight: 3.1 Kg
- -Mains voltage: 100 - 240 VAC, 50/60 HZ
- -Maximum power: 35 VA
- -Safety class: Class I
- -Treatment time: 0-30 minutes
- Procedures of Ultra Phonophoresis; Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of a hyaluronic acid-containing gel will be applied gel pad over the wrist and along the course of median nerve at the carpal tunnel.
The following parameters will be used: intensity of 1.0 W/em2 at a 1MHz frequency for 5 minutes and pulsed (25%) ultrasound waves to transfer the hyaluronic acid-containing gel. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks.
The following parameters will be used:
- intensity of 1.0 W/cm2
- 1MHz frequency
- pulsed (25%)
- 5 min/session, 5 d/wk, for 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Ultra PhonophoresisThis group will include 30 patients who will receive Ultra Phonophoresis with a hyaluronic acid-containing gel 5 sessions per week for 3 weeks in addition to their physical therapy program and medical treatment. |
| Control group: | No intervention | –This group will include 30 patients who will receive only their traditional physical therapy program and medical treatment. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range between 40-55 years.
- Female patients will participate in the study.
- All patients will have hormonal therapy at least for 6 weeks.
- All patients enrolled to the study will have their informed consent.
- Patient referred from physician by carpal tunnel syndrome
Key exclusion criteria (5 listed)
- -Marked lymphedema.
- Steroid injection for CTS.
- Thrombosis propensity.
- Cervical radiculopathy.
- Brachial plexopathy
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 |
|---|---|---|
| Ultra PhonophoresisTherapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of a hyaluronic acid-containing gel will be applied gel pad over the wrist and along the course of median nerve at the carpal tunnel. The following parameters will be used: intensity of 1.0 W/em2 at a 1MHz frequency for 5 minutes and pulsed (25%) ultrasound waves to transfer the hyaluronic acid-containing gel. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks. The following parameters will be used: * intensity of 1.0 W/cm2 * 1MHz frequency * pulsed (25%) * 5 min/session, 5 d/wk, for 3 weeks. | Device | Study group |
Primary outcome
Median nerve sensory and motor distal latency
Time frame: 3 weeks
For assessing the Motor distal latency, the active recording electrode will be fastened on abductor pollicis brevis (APB) muscle and median nerve will be stimulated at wrist region with stimulator electrode, 8 cm proximal to the active electrode and then the distal latency will be recorded. Regarding the sensory distal latency, the recorder will be fastened on the third finger, and stimulator electrode will be placed 14 cm proximal to the recorder and will stimulate median nerve once at wrist and once at palm region, then distal latency will be recorded. Normal distal sensory latency of median nerve is of less than 3.6 and distal motor latency of median nerve less than 4.2. If only the sensory distal latency will long, patient has mild CTS, but if both sensory and motor distal latency will be long and denervation will not be observed in electromyography of APB, it is moderate CTS.
pain using a visual analogue scale (VAS)
Time frame: 3 weeks
Intensity of pain is another outcome measure will be used to evaluate treatment. Adults use the visual analogue scale (VAS), a one-dimensional assessment tool, particularly for chronic pain. The VAS is a continuous scale that consists of a line that is either vertical (VVAS) or horizontal (HVAS), usually 10 cm long, and is supported by two verbal descriptors, one for each symptom intensity. The patients will be thoroughly briefed on the instructions, reporting timeline, and vocal description anchors prior to the measurement.
Baseline hydraulic hand dynamometer is used to measure hand grip strength
Time frame: 3 weeks
. It is manufactured and serviced in the USA since 1978. It gives accurate grip strength readings without the subject being able to feel the handle move. The internationally accepted design ensures reliability, user convenience and measurement repeatability. Maximum reading remains until the unit is reset. The device comes with five position handles to improve comfort while using the dynamometer. The device Gauge is made of bourdon tube element with spring suspended movement that can viewed as pounds or kilograms.
Boston Carpal Tunnel Questionnaire (BCTQ):
Time frame: 3 weeks
Patients with CTS can assess their level of dysfunction and symptom severity using the BCTQ .It has two measurement scales: the BCTQ-F, which measures functional status, and the BCTQ-S, which measures symptom severity. The BCTQ-S employs eleven questions on a five-point rating system from 1 (no symptoms) to 5 (severe symptoms) to assess the frequency and intensity of pain, numbness, weakness, and loss of dexterity. The average scores of the 11 questions are used to analyze the results. The BCTQ-F has eight questions that are scored on a five-point scale from 1 (no trouble) to 5 (cannot do at all owing to hand or wrist symptoms) to assess the degree of difficulty in carrying out daily chores. The average scores of the eight questions are used to analyze the results.
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 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra Phonophoresis in people with Mastectomy and Carpal Tunnel Syndrome (CTS), run by Cairo 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 5 inclusion and 5 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 18 Sep 2025. 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?
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?
Median nerve sensory and motor distal latency (time frame: 3 weeks). 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?
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 18 Sep 2025.