Shoulder InstabilityESTABLENCT07457931

Shoulder Instability Surgery: Latarjet Technique With Surgical Tape Versus Screw Fixation

A study testing Metal screw fixation of the coracoid graft during the Latarjet procedure. and High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure. in people with Shoulder Instability and Shoulder, run by Juan Ameztoy at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Anterior shoulder instability is a common condition, particularly in young and active patients, and may lead to recurrente shoulder dislocations, pain, and functional limitations. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Shoulder Instability, Shoulder, Latarjet
What is being tested?: Metal screw fixation of the coracoid graft during the Latarjet procedure. and High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure.
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteSpain
Study dates: 3 Mar 2026to 1 Feb 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age between 18 and 50 years at the time of surgery.
Clinical and radiological diagnosis of anterior shoulder instability.
Indication for surgical treatment with the open Latarjet procedure, as determined by the treating surgeon.
Ability to understand the study procedures and provide written informed consent.
Willingness and ability to comply with the postoperative follow-up schedule.

Who cannot join

Multidirectional or posterior shoulder instability.
Previous surgical procedures on the affected shoulder.
Concomitant shoulder pathology requiring additional surgical treatment, including rotator cuff tears, glenohumeral osteoarthritis, or pathology of the long head of the biceps tendon.
Systemic, neurological, or vascular conditions that could affect upper limb function or influence study outcomes.
Contraindication to surgery or general anesthesia.
Inability to complete follow-up assessments or comply with study procedures.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario La Paz
Madrid, Madrid, 28046

Other trials in Spain

About this study

Official title: ESTABLE: A Randomized Control Trial of Shoulder Instability Using the Latarjet Procedure With Suture Tape Cerclage Versus Screw Fixation

Anterior shoulder instability is a common condition, particularly in young and active patients, and may lead to recurrente shoulder dislocations, pain, and functional limitations.

The open Latarjet procedure is a widely used surgical technique to treat this condition, especially in patients with significant glenoid bone loss.

In the traditional Latarjet procedure, the transferred coracoid bone graft is fixed to the anterior glenoid using metallic screws. Although screw fixation provides stable compression, implant-related complications have been reported, including hardware irritation, screw loosening, graft fracture and the need for hardware removal.

High-strength suture tape cerclage has been proposed as an alternative fixation method that may reduce implant-related complications while maintaining adequate graft stability.

This study aims to compare coracoid graft fixation using high-strength suture tape cerclage versus conventional metallic screw fixation in patients undergoing the Latarjet procedure for anterior shoulder instability.

Participants will be randomly assigned in a 1:1 ratio to receive either screw fixation or suture tape cerclage fixation. Clinical and radiological outcomes will be evaluated during postoperative follow-up, including shoulder function, pain, return to sports activity, complications and graft healing.

This study will be conducted at Hospital Universitario La Paz (Madrid, Spain), with a planned sample size of approximately 80 patients and a minimum follow-up of 12 months.

Read the detailed description

This study is designed as a prospective, single-center, randomized clinical trial comparing two methods of coracoid bone graft fixation in the open Latarjet procedure for the treatment of anterior shoulder instability.

Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. The experimental group will undergo coracoid graft fixation using high-strength suture tape cerclage, while the control group will receive conventional fixation using two metallic screws. Randomization will be performed using permuted blocks.

All surgical procedures will be performed at Hospital Universitario La Paz (Madrid, Spain) by surgeons experienced in shoulder surgery. The surgical approach and operative steps of the Latarjet procedure will be standardized across both groups. The only difference between groups will be the fixation method used to secure the transferred coracoid graft to the anterior glenoid.

In the suture tape cerclage group, fixation will be achieved using interconnected high-strength suture tapes passed through bone tunnel to compress the graft against the glenoid. In the control group, the graft will be fixed using two metallic screws, which represents the conventional fixation technique.

Because of the nature of the surgical intervention, surgeons cannot be blinded to the fixation technique used during the procedure.

Postoperative care and rehabilitation protocols will be standardized for all participants. Clinical follow-up visits will include assessment of shoulder function, pain, return to sports activity, and postoperative complications. Radiological evaluation will be performed using computed tomography to assess graft healing and position.

Conditions: Shoulder Instability, Shoulder, Latarjet, Anterior Shoulder Instability, Anterior Shoulder Dislocation
Being tested: Metal screw fixation of the coracoid graft during the Latarjet procedure., High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure.
Keywords: latarjet, cerclage, screws, shoulder, instability, anterior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Metal screw fixation of the coracoid graft during the Latarjet procedure.Procedure or surgery
Also called Latarjet, screw, fixation
This intervation is based on coracoid fixation using screws
High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure.Procedure or surgery
Also called suture tape, cerclage, latarjet
Latarjet procedure with coracoid fixation using a metal free technique with suture tape cerclage

Study groups in NCT07457931
Study group	Role	What they receive
Screw fixation	Active comparator	Latarjet technique with screw fixation Receives: Procedure: Metal screw fixation of the coracoid graft during the Latarjet procedure.
Tape cerclage fixation	Active comparator	Latarjet technique fixed with cerclage fixation Receives: Procedure: High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

WOSI score
The primary outcome of this study is shoulder-specific functional outcome at 12 months following surgery, measured using the Western Ontario Shoulder Instability Index (WOSI).
The WOSI is a validated, disease-specific patient-reported outcome measure designed to assess quality of life and functional impairment in patients with shoulder instability. It consists of 21 items grouped into four domains: physical symptoms, sport/recreation/work function, lifestyle function, and emotional well-being. Each item is scored on a visual analog scale, and the total score ranges from 0 to 2100 points, where lower scores indicate better shoulder function and fewer symptoms.
The primary analysis will compare the total WOSI score at 12 months postoperatively between the two study groups: high-strength suture tape cerclage fixation and metal screw fixation of the coracoid graft in the Latarjet procedure.
Measured: 12 months postoperative

Secondary outcomes (5)

ROWE score
A secondary outcome of this study is shoulder stability and functional outcome at 12 months following surgery, assessed using the ROWE Score.
The ROWE Score is a validated clinical scoring system specifically developed to evaluate outcomes in patients with shoulder instability. It assesses three main components: stability (50 points), motion (20 points), and function (30 points), with a total possible score of 100 points. Higher scores indicate better shoulder stability and function.
The total ROWE Score at 12 months postoperatively will be compared between the two study groups: high-strength suture tape cerclage fixation and metal screw fixation of the coracoid graft during the Latarjet procedure.
Measured: 12 months
VAS score
A secondary outcome of this study is postoperative shoulder pain at 12 months, assessed using the Visual Analog Scale (VAS).
The VAS is a validated and widely used patient-reported measure of pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0) and "worst imaginable pain" (10). Patients are asked to indicate the point on the line that best represents their current level of shoulder pain. The score is recorded as a numerical value from 0 to 10, with higher scores indicating greater pain intensity.
Pain levels at 12 months following surgery will be compared between the two study groups: high-strength suture tape cerclage fixation and metal screw fixation of the coracoid graft in the Latarjet procedure.
Measured: 12 months
Return to sports
A secondary outcome of this study is return to sport following surgery, evaluated at 12 months postoperatively.
Return to sport will be defined as the patient's ability to resume participation in sports activities at the same or lower level compared to pre-injury status. Information will be collected regarding whether the patient has returned to sport (yes/no), the level of performance achieved (same level, lower level, or unable to return), and the time elapsed from surgery to return to sport (measured in months).
Measured: 12 months
Radiological graft union
A secondary outcome of this study is radiological consolidation of the coracoid graft at 12 months following surgery.
Graft union will be assessed using computed tomography (CT) scans performed at 3 and 12 months postoperatively. Radiological consolidation will be defined as the presence of continuous trabecular bone bridging between the coracoid graft and the native glenoid bone, without radiolucent lines suggestive of non-union
Measured: 3 months and 12 months
Postoperative complications
A secondary outcome of this study is the incidence of postoperative complications within 12 months following surgery.
Complications will include both early and late adverse events related to the surgical procedure or the fixation method. Specifically, the following events will be recorded: coracoid graft fracture, significant graft resorption, graft malposition, fixation device malposition or failure, non-union, recurrent instability, infection, neurovascular injury, and need for reoperation (including hardware removal or revision surgery).
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 20261 Feb 2027

First posted9 Mar 2026
Study start3 Mar 2026
Primary completion1 Jan 2027 (estimated)
Study completion1 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Shoulder InstabilityStudies 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: Single blind
Who is masked: Participant
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07457931
Sponsor's protocol ID: EC2025.639
Acronym: ESTABLE
Status last verified: Mar 2026
First submitted: 3 Mar 2026
Last updated: 11 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared due to institutional data protection policies and compliance with European data protection regulations (GDPR), which restrict public dissemination of patient-level data. The study does not include external funding or infrastructure to support controlled data-sharing agreements. Only aggregated results will be published.

Publications

Hachem AI, Ahmed U, Ixtacuy LR, Molina-Creixell A, Campagnoli A, Rius X. Open Latarjet with Metal-Free Cerclage Fixation. Arthrosc Tech. 2023 Mar 3;12(4):e465-e475. doi: 10.1016/j.eats.2022.11.030. eCollection 2023 Apr.
PubMed 37138684
Jos S, Sanu S, J A, Thomas M L, Paulose B. Arthroscopic Latarjet Procedure Using FiberTape Cerclage With a Simplified Technique for Suture Passage and Coracoid Fixation. Arthrosc Tech. 2022 Jun 21;11(7):e1277-e1287. doi: 10.1016/j.eats.2022.03.011. eCollection 2022 Jul.
PubMed 35936836
Provencher MT, Aman ZS, LaPrade CM, Bernhardson AS, Moatshe G, Storaci HW, Chahla J, Turnbull TL, LaPrade RF. Biomechanical Comparison of Screw Fixation Versus a Cortical Button and Self-tensioning Suture for the Latarjet Procedure. Orthop J Sports Med. 2018 Jun 14;6(6):2325967118777842. doi: 10.1177/2325967118777842. eCollection 2018 Jun.
PubMed 29977940
Ganokroj P, Dey Hazra M, Dey Hazra RO, Brady AW, Brown JR, Rupp MC, Garcia AR, Whalen RJ, Millett PJ, Provencher MT. Biomechanical Evaluation of the 2 Different Levels of Coracoid Graft Positions in the Latarjet Procedure for Anterior Shoulder Instability. Orthop J Sports Med. 2023 Dec 22;11(12):23259671231202533. doi: 10.1177/23259671231202533. eCollection 2023 Dec.
PubMed 38145219
Vetoshkin AA, Mikhaylova KD. Learning curve in the arthroscopic Latarjet procedure: An analysis of the first 171 cases. J Orthop. 2023 Nov 30;50:58-64. doi: 10.1016/j.jor.2023.11.048. eCollection 2024 Apr.
PubMed 38173830
Boileau P, Mercier N, Roussanne Y, Thelu CE, Old J. Arthroscopic Bankart-Bristow-Latarjet procedure: the development and early results of a safe and reproducible technique. Arthroscopy. 2010 Nov;26(11):1434-50. doi: 10.1016/j.arthro.2010.07.011.
PubMed 21035007
Griesser MJ, Harris JD, McCoy BW, Hussain WM, Jones MH, Bishop JY, Miniaci A. Complications and re-operations after Bristow-Latarjet shoulder stabilization: a systematic review. J Shoulder Elbow Surg. 2013 Feb;22(2):286-92. doi: 10.1016/j.jse.2012.09.009.
PubMed 23352473
Gupta A, Delaney R, Petkin K, Lafosse L. Complications of the Latarjet procedure. Curr Rev Musculoskelet Med. 2015 Mar;8(1):59-66. doi: 10.1007/s12178-015-9258-y.
PubMed 25644052

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
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Surgeons, Shoulder Instability
Recruiting
Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.
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Recruiting
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All Shoulder Instability trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ESTABLE: A Randomized Control Trial of Shoulder Instability Using the Latarjet Procedure With Suture Tape Cerclage Versus Screw Fixation
ClinicalTrials.gov ID: NCT07457931
Acronym / sponsor ID: ESTABLE / EC2025.639
Conditions: Shoulder Instability, Shoulder, Latarjet, Anterior Shoulder Instability, Anterior Shoulder Dislocation
Keywords: latarjet, cerclage, screws, shoulder, instability, anterior
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Juan AmeztoyUniversity, hospital or other
Study start: 3 Mar 2026 (actual)
Primary completion: 1 Jan 2027 (estimated)
Study completion: 1 Feb 2027 (estimated)
First posted: 9 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Anterior shoulder instability is a common condition, particularly in young and active patients, and may lead to recurrente shoulder dislocations, pain, and functional limitations.

The open Latarjet procedure is a widely used surgical technique to treat this condition, especially in patients with significant glenoid bone loss.

High-strength suture tape cerclage has been proposed as an alternative fixation method that may reduce implant-related complications while maintaining adequate graft stability.

This study will be conducted at Hospital Universitario La Paz (Madrid, Spain), with a planned sample size of approximately 80 patients and a minimum follow-up of 12 months.

Detailed description

Because of the nature of the surgical intervention, surgeons cannot be blinded to the fixation technique used during the procedure.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Screw fixation	Active comparator	Procedure: Metal screw fixation of the coracoid graft during the Latarjet procedure.Latarjet technique with screw fixation
Tape cerclage fixation	Active comparator	Procedure: High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure.Latarjet technique fixed with cerclage fixation

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age between 18 and 50 years at the time of surgery.
Clinical and radiological diagnosis of anterior shoulder instability.
Indication for surgical treatment with the open Latarjet procedure, as determined by the treating surgeon.
Ability to understand the study procedures and provide written informed consent.
Willingness and ability to comply with the postoperative follow-up schedule.

Key exclusion criteria (6 listed)

Multidirectional or posterior shoulder instability.
Previous surgical procedures on the affected shoulder.
Concomitant shoulder pathology requiring additional surgical treatment, including rotator cuff tears, glenohumeral osteoarthritis, or pathology of the long head of the biceps tendon.
Systemic, neurological, or vascular conditions that could affect upper limb function or influence study outcomes.
Contraindication to surgery or general anesthesia.

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
Metal screw fixation of the coracoid graft during the Latarjet procedure.Also: Latarjet, screw, fixationThis intervation is based on coracoid fixation using screws	Procedure or surgery	Screw fixation
High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure.Also: suture tape, cerclage, latarjetLatarjet procedure with coracoid fixation using a metal free technique with suture tape cerclage	Procedure or surgery	Tape cerclage fixation

Primary outcome

WOSI score
Time frame: 12 months postoperative
The primary outcome of this study is shoulder-specific functional outcome at 12 months following surgery, measured using the Western Ontario Shoulder Instability Index (WOSI). The WOSI is a validated, disease-specific patient-reported outcome measure designed to assess quality of life and functional impairment in patients with shoulder instability. It consists of 21 items grouped into four domains: physical symptoms, sport/recreation/work function, lifestyle function, and emotional well-being. Each item is scored on a visual analog scale, and the total score ranges from 0 to 2100 points, where lower scores indicate better shoulder function and fewer symptoms. The primary analysis will compare the total WOSI score at 12 months postoperatively between the two study groups: high-strength suture tape cerclage fixation and metal screw fixation of the coracoid graft in the Latarjet procedure.

5 secondary outcomes

ROWE score
Time frame: 12 months
VAS score
Time frame: 12 months
Return to sports
Time frame: 12 months
Radiological graft union
Time frame: 3 months and 12 months
Postoperative complications
Time frame: 12 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 11 Mar 2026.
Background: PubMed 37138684Hachem AI, Ahmed U, Ixtacuy LR, Molina-Creixell A, Campagnoli A, Rius X. Open Latarjet with Metal-Free Cerclage Fixation. Arthrosc Tech. 2023 Mar 3;12(4):e465-e475. doi: 10.1016/j.eats.2022.11.030. eCollection 2023 Apr.
Background: PubMed 35936836Jos S, Sanu S, J A, Thomas M L, Paulose B. Arthroscopic Latarjet Procedure Using FiberTape Cerclage With a Simplified Technique for Suture Passage and Coracoid Fixation. Arthrosc Tech. 2022 Jun 21;11(7):e1277-e1287. doi: 10.1016/j.eats.2022.03.011. eCollection 2022 Jul.
Background: PubMed 29977940Provencher MT, Aman ZS, LaPrade CM, Bernhardson AS, Moatshe G, Storaci HW, Chahla J, Turnbull TL, LaPrade RF. Biomechanical Comparison of Screw Fixation Versus a Cortical Button and Self-tensioning Suture for the Latarjet Procedure. Orthop J Sports Med. 2018 Jun 14;6(6):2325967118777842. doi: 10.1177/2325967118777842. eCollection 2018 Jun.
Background: PubMed 38145219Ganokroj P, Dey Hazra M, Dey Hazra RO, Brady AW, Brown JR, Rupp MC, Garcia AR, Whalen RJ, Millett PJ, Provencher MT. Biomechanical Evaluation of the 2 Different Levels of Coracoid Graft Positions in the Latarjet Procedure for Anterior Shoulder Instability. Orthop J Sports Med. 2023 Dec 22;11(12):23259671231202533. doi: 10.1177/23259671231202533. eCollection 2023 Dec.
Background: PubMed 38173830Vetoshkin AA, Mikhaylova KD. Learning curve in the arthroscopic Latarjet procedure: An analysis of the first 171 cases. J Orthop. 2023 Nov 30;50:58-64. doi: 10.1016/j.jor.2023.11.048. eCollection 2024 Apr.
Background: PubMed 21035007Boileau P, Mercier N, Roussanne Y, Thelu CE, Old J. Arthroscopic Bankart-Bristow-Latarjet procedure: the development and early results of a safe and reproducible technique. Arthroscopy. 2010 Nov;26(11):1434-50. doi: 10.1016/j.arthro.2010.07.011.
Background: PubMed 23352473Griesser MJ, Harris JD, McCoy BW, Hussain WM, Jones MH, Bishop JY, Miniaci A. Complications and re-operations after Bristow-Latarjet shoulder stabilization: a systematic review. J Shoulder Elbow Surg. 2013 Feb;22(2):286-92. doi: 10.1016/j.jse.2012.09.009.
Background: PubMed 25644052Gupta A, Delaney R, Petkin K, Lafosse L. Complications of the Latarjet procedure. Curr Rev Musculoskelet Med. 2015 Mar;8(1):59-66. doi: 10.1007/s12178-015-9258-y.
Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and compliance with European data protection regulations (GDPR), which restrict public dissemination of patient-level data. The study does not include external funding or infrastructure to support controlled data-sharing agreements. Only aggregated results will be published.

Related trials for Shoulder Instability

Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
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Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
Recruiting
Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.
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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?

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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 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 Spain. 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?

WOSI score (time frame: 12 months postoperative). 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 NCT07457931, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.