Rotator Cuff SyndromeNCT02493660

A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

A study testing InSpace sub-acromial tissue spacer system and Partial repair of rotator cuff in people with Rotator Cuff Syndrome, run by OrthoSpace Ltd. at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT). Read more about this study

Who is it for?: Ages 40 to 100 years
Conditions the study is for: Rotator Cuff Syndrome
What is being tested?: InSpace sub-acromial tissue spacer system and Partial repair of rotator cuff
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 21 sitesin 2 countries
Study dates: 26 Jun 2015to 17 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 100 years
All sexes
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring ≥ 5 cm in diameter involving ≥ two tendons (confirmed Intra-operatively)
Functional deltoid muscle and preserved passive range of motion on physical examination
Documented VAS score of > 30 mm pain
Failed non-operative treatment of at least 4 months
Patient in general good health,independent, and can comply with all post-operative evaluations and visits.

Main Exclusion Criteria:

Known allergy to the device material (copolymer of PLA and -ε-caprolactone)
Evidence of the following conditions:

significant gleno-humeral or acromiohumeral arthritis
full thickness cartilage loss as seen on MRI
gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
pre-existing deltoid defect or deltoid palsy
major joint trauma, infection or necrosis
partial thickness tears of the supraspinatous
fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired]

The subject requires concomitant subscapularis repair and/or labral repair
Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder
Major medical condition that could affect quality of life and influence the results of the study (e.g. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
Documented evidence of a history of drug/alcohol abuse within 12 months of enrollment
The subject's condition represents a worker's compensation case
The subject is currently involved in a health-related litigation procedure
Females of child-bearing potential who are pregnant or breastfeeding or plan to become pregnant during the course of the study
Concurrent participation in any other investigational clinical study one month prior to enrollment or during the entire study period
The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .
The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up
The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
The subject currently has an acute infection in the area surrounding the surgical site.

Trial locations and contacts

21 sites in 2 countries.

Country

City, postcode or hospital

21 sites in 2 countries

United States18 sites

Johns Hopkins
Baltimore, Maryland, 21205-1911
MedStar Union Memorial Orthopaedics
Baltimore, Maryland, 21218
Brigham & Women's Hospital
Boston, Massachusetts, 02166
Midwest Orthopedics at RUSH
Chicago, Illinois, 60612
Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health
Cincinnati, Ohio, 45209
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Colorado
Denver, Colorado, 80222
Holy Cross Hospital
Fort Lauderdale, Florida, 33334
Tulane University School of Medicine
New Orleans, Louisiana, 70112
NYU
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
University of Buffalo Buffalo
New York, New York, 14260
The Ohio State University
Ohio City, Ohio, 43210
Rothman Institute
Philadelphia, Pennsylvania, 19152
Rockford Orthopedic Associates
Rockford, Illinois, 51107
University Orthopedic Center
State College, Pennsylvania, 16801
Upstate Orthopedics
Syracuse, New York, 13057
Southern California Orthopedic Institute
Van Nuys, California, 91405

Other trials in United States

Canada3 sites

Fowler Kennedy Sport Medicine Clinic
London, Ontario
Roth McFarlane Hand and Upper Limb Center
London, Ontario
Ottawa Hospital Research Institute
Ottawa, Ontario

Other trials in Canada

About this study

Official title: A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).

Read the detailed description

This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.

Conditions: Rotator Cuff Syndrome
Being tested: InSpace sub-acromial tissue spacer system, Partial repair of rotator cuff
Keywords: Massive Rotator Cuff Tear, Arthroscopy, Shoulder Joint, Rotator cuff partial repair

What participants receive

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

InSpace sub-acromial tissue spacer systemDevice
Arthroscopic implantation of InSpace sub-acromial tissue spacer system
Partial repair of rotator cuffProcedure or surgery
Arthroscopic partial repair of rotator cuff

Study groups in NCT02493660
Study group	Role	What they receive
InSpace implantation	Experimental	Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation Receives: Device: InSpace sub-acromial tissue spacer system
Tendon Repair	Active comparator	Arthroscopic partial repair of rotator cuff Receives: Procedure: Partial repair of rotator cuff

What is being measured

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

Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.
The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).
The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.
Measured: Baseline to month 12

Secondary outcomes (9)

Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24
Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified).
Measured: Baseline through to Month 24
Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)
The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).
Measured: Baseline to month 12
Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)
The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs)..
The total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair.
Measured: Baseline to month 12
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC
The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair.
Measured: Baseline through to month 24
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES
Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24.
The improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.
Measured: Baseline through to month 24
Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair.
Measured: Baseline to month 24
The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair.
Measured: Baseline through to month 24
Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair.
Measured: Baseline through to month 24
Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair.
Measured: Baseline through to month 24

Timeline

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

26 Jun 201517 Mar 2020

First posted9 Jul 2015 (estimated)
Study start26 Jun 2015
Primary completion29 Feb 2020
Study completion17 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rotator Cuff SyndromeStudies 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: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02493660
Sponsor's protocol ID: CLD-OR-010
Status last verified: Jun 2022
First submitted: 1 Jul 2015
Last updated: 15 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome

All Rotator Cuff Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
ClinicalTrials.gov ID: NCT02493660
Acronym / sponsor ID: CLD-OR-010
Conditions: Rotator Cuff Syndrome
Keywords: Massive Rotator Cuff Tear, Arthroscopy, Shoulder Joint, Rotator cuff partial repair
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: OrthoSpace Ltd.Industry (pharma, biotech, devices)
Study start: 26 Jun 2015 (actual)
Primary completion: 29 Feb 2020 (actual)
Study completion: 17 Mar 2020 (actual)
First posted: 9 Jul 2015 (estimated)
Results: Posted 22 Jul 2021

Clinical summary

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

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).

Detailed description

Study design

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

Arm	Type	Receives
InSpace implantation	Experimental	Device: InSpace sub-acromial tissue spacer systemArthroscopic InSpace (Sub-acromial tissue spacer system) implantation
Tendon Repair	Active comparator	Procedure: Partial repair of rotator cuffArthroscopic partial repair of rotator cuff

Who may qualify

Ages: 40 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
InSpace sub-acromial tissue spacer systemArthroscopic implantation of InSpace sub-acromial tissue spacer system	Device	InSpace implantation
Partial repair of rotator cuffArthroscopic partial repair of rotator cuff	Procedure or surgery	Tendon Repair

Primary outcome

Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.
Time frame: Baseline to month 12
The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs). The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.

9 secondary outcomes

Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24
Time frame: Baseline through to Month 24
Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)
Time frame: Baseline to month 12
Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)
Time frame: Baseline to month 12
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC
Time frame: Baseline through to month 24
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES
Time frame: Baseline through to month 24
Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Time frame: Baseline to month 24
The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Time frame: Baseline through to month 24
Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Time frame: Baseline through to month 24
Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Time frame: Baseline through to month 24

Results and safety

Results posted to the registry on 22 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
InSpace Implantation	93	83
Tendon Repair	91	79

Primary outcome: Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.

Time frame: Baseline to month 12. Number. Unit: percentage of participants

Measure	InSpace Implantation n = 88	Tendon Repair n = 88
Value	51.1	39.8

InSpace Implantation vs Tendon Repair: p = 0.0049, Regression, Logistic

Population analysed: Percentage of participants in the Per Protocol Population (PP) with surgical treatment success of the InSpace device as a Primary surgical treatment for Full-thickness massive rotator cuff tears (MRCT).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collected over 12 months and 24 months visit.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
InSpace Implantation	22 of 93 (23.7%)	67 of 93 (72%)	0 of 93
Tendon Repair	22 of 91 (24.2%)	69 of 91 (75.8%)	1 of 91

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rotator Cuff Syndrome

Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome

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.

Assaf Dekel, MD study director

Ortho-Space

21 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing InSpace sub-acromial tissue spacer system and Partial repair of rotator cuff in people with Rotator Cuff Syndrome, run by OrthoSpace Ltd. at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 22 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs. (time frame: Baseline to month 12). 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 NCT02493660.

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 15 Jun 2022.