Adhesive Capsulitis of ShoulderNCT05384093
Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
A study testing High Intensity Stretch Device in people with Adhesive Capsulitis of Shoulder, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
Trial summary
Study 1 - Adhesive Capsulitis Study - 110 patients The purpose of this study is to compare treatment of patients with symptoms of adhesive capsulitis, primary and secondary, between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- High Intensity Stretch Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2019to 25 Oct 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exhibits symptoms of adhesive capsulitis i. Shoulder pain with limited motion for more than one month ii. AND ≤ 30 degrees external rotation with arm at side iii. AND ≤ 130 degrees forward flexion d. Cortisone shot for all patients
- Is not recovering normally based on objective criteria set for screening process i. Step 1 - Follow patients -all post-op patients with indicated procedures (see # 7 for list.) ii. Step 2 - Screen Patients -does patient meets inclusion criteria at 6 weeks or 3 months of follow-up?
- < 15 degrees external rotation with arm at side at 6 weeks post-op
- OR < 90 degrees forward flexion at 3 months post-op iii. Step 3 - Enroll patients that meet inclusion criteria and assign group
- Underwent a manipulation under anesthesia or a lysis of adhesions procedure
Who cannot join
- a. No prior shoulder surgery b. Infection c. Rheumatoid arthritis d. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder
- For Study Group 2 - Postoperative Shoulder Stiffness Study (POS)
- Revision surgery b. Infection c. Rheumatoid arthritis
- 7. Procedures included
- Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)
- ORIF Humerus fracture (23615)
Show all 11Show fewer
- For Study Group 3, Secondary Surgery Study (SAM)
- Infection b. Rheumatoid arthritis c. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder
- 7. Procedures included
- Manipulation under anesthesia (23700)
- Lysis of adhesions (29825)
Trial locations and contacts
1 site in 1 country.
United States1 site
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33607
About this study
Official title: Outcomes of Treatment Using the ERMI Shoulder Flexionater®
Study 1 - Adhesive Capsulitis Study - 110 patients The purpose of this study is to compare treatment of patients with symptoms of adhesive capsulitis, primary and secondary, between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.
Study 2 - Postoperative Shoulder Stiffness Study - 90 patients The purpose of this study is to compare treatment of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.
Study 3 - Stiffness after MUA Study - enroll all eligible patients (goal of at least 15) The purpose of this study is to compare treatment of patients who have undergone manipulation under anesthesia or lysis of adhesions between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.
Read the detailed description
Study 1 - Adhesive Capsulitis Study (AC)
Objective: The purpose of this study is to compare treatment efficacy of patients with symptoms of primary and secondary adhesive capsulitis between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.
- Prospective randomized control trial
- Sample size - 110 patients
- Study Groups:
- Group I - Physical Therapy Only
- Group II - Flexionater® only
- Group III - Flexionater® and Physical Therapy
- Length of study - 2-year follow-up from last enrolled patient
Study 2 - Postoperative Shoulder Stiffness Study (POS)
Objective: The purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Patients treated with Physical Therapy alone; II) Patients treated with the ERMI Shoulder Flexionater® alone; III) Patients treated with PT + Device in the treatment.
- Prospective randomized control trial
- Sample size - 90 enrolled patients
- Study Groups:
- Group I - Physical Therapy only
- Group II - Flexionater® only
- Group III - Flexionater® and Physical Therapy
- Length of study - 2-year follow-up from last enrolled patient
Study 3 - Secondary Surgery Study (SAM)
Objective: The purpose of this study is to compare recovery of patients who have undergone a manipulation under anesthesia or a lysis of adhesions between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.
- Prospective randomized control trial
- Sample size - 10 enrolled patients
- Study Groups:
- Group I Physical Therapy Only
- Group II - - Flexionater® only
- Group III - Flexionater® and Physical Therapy
- Length of study - 2-year follow-up from last enrolled patient
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- High Intensity Stretch Device
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Stretch DeviceDevice
Also called Physical Therapy
High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.
| Study group | Role | What they receive |
|---|---|---|
| Adhesive Capsulitis Study | Active comparator | The purpose of this study is to compare treatment efficacy of patients with symptoms of primary and secondary adhesive capsulitis between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment. Receives: Device: High Intensity Stretch Device |
| Post operative Shoulder Stiffness Study | Active comparator | The purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Patients treated with Physical Therapy alone; II) Patients treated with the ERMI Shoulder Flexionater® alone; III) Patients treated with PT + Device in the treatment. Receives: Device: High Intensity Stretch Device |
| Secondary Surgery Study | Active comparator | The purpose of this study is to compare recovery of patients who have undergone a manipulation under anesthesia or a lysis of adhesions between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment. Receives: Device: High Intensity Stretch Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Range of Motion Improvement
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Measured: 3 months
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Measured: 6 months
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Measured: 12 months
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Measured: 24 months
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Measured: 6 weeks
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Measured: baseline
VAS (Visual Analog Scale) Pain Score
Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be)
Measured: 3 months
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Measured: 6 weeks
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Measured: 6 months
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Measured: 12 months
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Measured: 24 months
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Measured: baseline
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Measured: baseline
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Measured: 3 month
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Measured: 6 weeks
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Measured: 6 months
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Measured: 12 months
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Measured: 24 months
Secondary outcomes (9)
SST
Simple Shoulder Test
Measured: Baseline
SST
Simple Shoulder Test
Measured: 3 month
SST
Simple Shoulder Test
Measured: 6 weeks
SST
Simple Shoulder Test
Measured: 6 months
SST
Simple Shoulder Test
Measured: 12 months
SST
Simple Shoulder Test
Measured: 24 months
Device Compliance Questionnaire (if applicable)
compliance with Device usage
Measured: 6 weeks
Device Compliance Questionnaire (if applicable)
compliance with Device usage
Measured: 3 months
Device Compliance Questionnaire (if applicable)
compliance with Device usage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start25 Jun 2019
- Primary completion25 Oct 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
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 Adhesive Capsulitis of ShoulderStudies 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Ermi LLC
- Responsible party
- Sponsor
- Investigators
- Peter Simon, PhD, Study director, Foundation for Orthopaedic Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384093
- Sponsor's protocol ID
- FORE AC 2019
- Status last verified
- Sep 2026
- First submitted
- 3 May 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: unknown at this time
Publications
Teytelbaum DE, Kumar NS, Dent CS, Neaville S, Warren DH, Simon P, Baker CE. Efficacy of a high-intensity home stretching device and traditional physical therapy in non-operative management of adhesive capsulitis - a prospective, randomized control trial. BMC Musculoskelet Disord. 2024 Apr 20;25(1):305. doi: 10.1186/s12891-024-07448-4.
PubMed 38643086
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Treatment Using the ERMI Shoulder Flexionater®
- ClinicalTrials.gov ID
- NCT05384093
- Acronym / sponsor ID
- FORE AC 2019
- Conditions
- Adhesive Capsulitis of Shoulder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Collaborators
- Ermi LLC
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 20 May 2022 (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.
Study 1 - Adhesive Capsulitis Study - 110 patients The purpose of this study is to compare treatment of patients with symptoms of adhesive capsulitis, primary and secondary, between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.
Study 2 - Postoperative Shoulder Stiffness Study - 90 patients The purpose of this study is to compare treatment of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.
Study 3 - Stiffness after MUA Study - enroll all eligible patients (goal of at least 15) The purpose of this study is to compare treatment of patients who have undergone manipulation under anesthesia or lysis of adhesions between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.
Detailed description
Study 1 - Adhesive Capsulitis Study (AC)
Objective: The purpose of this study is to compare treatment efficacy of patients with symptoms of primary and secondary adhesive capsulitis between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.
- Prospective randomized control trial
- Sample size - 110 patients
- Study Groups:
- Group I - Physical Therapy Only
- Group II - Flexionater® only
- Group III - Flexionater® and Physical Therapy
- Length of study - 2-year follow-up from last enrolled patient
Study 2 - Postoperative Shoulder Stiffness Study (POS)
Objective: The purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Patients treated with Physical Therapy alone; II) Patients treated with the ERMI Shoulder Flexionater® alone; III) Patients treated with PT + Device in the treatment.
- Prospective randomized control trial
- Sample size - 90 enrolled patients
- Study Groups:
- Group I - Physical Therapy only
- Group II - Flexionater® only
- Group III - Flexionater® and Physical Therapy
- Length of study - 2-year follow-up from last enrolled patient
Study 3 - Secondary Surgery Study (SAM)
Objective: The purpose of this study is to compare recovery of patients who have undergone a manipulation under anesthesia or a lysis of adhesions between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.
- Prospective randomized control trial
- Sample size - 10 enrolled patients
- Study Groups:
- Group I Physical Therapy Only
- Group II - - Flexionater® only
- Group III - Flexionater® and Physical Therapy
- Length of study - 2-year follow-up from last enrolled patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adhesive Capsulitis Study | Active comparator | Device: High Intensity Stretch DeviceThe purpose of this study is to compare treatment efficacy of patients with symptoms of primary and secondary adhesive capsulitis between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment. |
| Post operative Shoulder Stiffness Study | Active comparator | Device: High Intensity Stretch DeviceThe purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Patients treated with Physical Therapy alone; II) Patients treated with the ERMI Shoulder Flexionater® alone; III) Patients treated with PT + Device in the treatment. |
| Secondary Surgery Study | Active comparator | Device: High Intensity Stretch DeviceThe purpose of this study is to compare recovery of patients who have undergone a manipulation under anesthesia or a lysis of adhesions between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Exhibits symptoms of adhesive capsulitis i. Shoulder pain with limited motion for more than one month ii. AND ≤ 30 degrees external rotation with arm at side iii. AND ≤ 130 degrees forward flexion d. Cortisone shot for all patients
- Is not recovering normally based on objective criteria set for screening process i. Step 1 - Follow patients -all post-op patients with indicated procedures (see # 7 for list.) ii. Step 2 - Screen Patients -does patient meets inclusion criteria at 6 weeks or 3 months of follow-up?
- < 15 degrees external rotation with arm at side at 6 weeks post-op
- OR < 90 degrees forward flexion at 3 months post-op iii. Step 3 - Enroll patients that meet inclusion criteria and assign group
- Underwent a manipulation under anesthesia or a lysis of adhesions procedure
Key exclusion criteria (11 listed)
- a. No prior shoulder surgery b. Infection c. Rheumatoid arthritis d. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder
- For Study Group 2 - Postoperative Shoulder Stiffness Study (POS)
- Revision surgery b. Infection c. Rheumatoid arthritis
- 7. Procedures included
- Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)
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 |
|---|---|---|
| High Intensity Stretch DeviceAlso: Physical TherapyHigh Intensity Stretch and Physical Therapy are used either together or alone to treat study arm. | Device | Adhesive Capsulitis Study, Post operative Shoulder Stiffness Study, Secondary Surgery Study |
Primary outcome
Shoulder Range of Motion Improvement
Time frame: 3 months
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: 6 months
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: 12 months
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: 24 months
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: 6 weeks
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: baseline
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
VAS (Visual Analog Scale) Pain Score
Time frame: 3 months
Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: 6 weeks
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: 6 months
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: 12 months
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: 24 months
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: baseline
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
ASES Score
Time frame: baseline
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 3 month
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 6 weeks
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 6 months
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 12 months
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 24 months
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
9 secondary outcomes
SST
Time frame: Baseline
SST
Time frame: 3 month
SST
Time frame: 6 weeks
SST
Time frame: 6 months
SST
Time frame: 12 months
SST
Time frame: 24 months
Device Compliance Questionnaire (if applicable)
Time frame: 6 weeks
Device Compliance Questionnaire (if applicable)
Time frame: 3 months
Device Compliance Questionnaire (if applicable)
Time frame: 6 months
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 9 Sep 2026.
- Derived from this study: PubMed 38643086Teytelbaum DE, Kumar NS, Dent CS, Neaville S, Warren DH, Simon P, Baker CE. Efficacy of a high-intensity home stretching device and traditional physical therapy in non-operative management of adhesive capsulitis - a prospective, randomized control trial. BMC Musculoskelet Disord. 2024 Apr 20;25(1):305. doi: 10.1186/s12891-024-07448-4.
- Individual participant dataSharing planned: Undecided. unknown at this time
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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.
Peter Simon, PhD study director
Foundation for Orthopaedic Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Stretch Device in people with Adhesive Capsulitis of Shoulder, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Shoulder Range of Motion Improvement (time frame: 3 months). The study lists 18 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 NCT05384093, 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 9 Sep 2026.