Acetabular Labrum TearPRP for ALTNCT06332352
Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears
A study testing PRP in people with Acetabular Labrum Tear, run by University of Utah at 1 site in United States.
Trial summary
Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Acetabular Labrum Tear
- What is being tested?
- PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to 1 Mar 2026
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≤49 years old (i.e., 18 - 49 years old)
- Hip or groin pain with at least 1 positive provocative labral hip maneuver (i.e., Flexion, Adduction, Internal Rotation (FADIR) test, subspine impingement test, scour)
- Radiographs with Tonnis grade < 2 (i.e., 0 or 1)
- MRI or MRA hip with evidence of acetabular labral tear
- Failure of at least 6 weeks of conservative management [i.e., activity modification, non-steroidal anti-inflammatory drugs (NSAIDs), and/or physical therapy (PT), other intra-articular injection etc.]
- Prior diagnostic ultrasound guided hip injection with anesthetic-only providing ≥50% pain relief
Who cannot join
- Any prior surgery to the affected hip
- Imaging with evidence of avascular necrosis of the affected hip
- Imaging with evidence of hip dysplasia (i.e. lateral center edge angle of ≤20 degrees)
- Alpha angle of ≥55 degrees of the affected hip
- Intra-articular hip injection within the last 6 months to the affected hip of any injectate with the exception of anesthetic
- Active systemic infection requiring antibiotics or local infection at the site of the injection
Show all 14Show fewer
- Any prior intra-articular infection of the affected hip
- Any prior fracture of the affected femur or pelvis
- Blood dyscrasia or malignancy
- Non-ambulatory patients
- Patient seeking care with active litigation pending
- Body mass index (BMI) ≥ 35 kg/m2
- Systemic inflammatory arthropathy
- Oral steroids consumed within the last three months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah - Department of Orthopaedics
Salt Lake City, Utah, 84108
About this study
Official title: Intra-articular Platelet-Rich Plasma in the Management of Acetabular Labral Tears: a Prospective Study
Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function.
Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants.
Read the detailed description
Acetabular labral tears (ALT) have been reported to have a prevalence of 22-55% in patients presenting with hip or groin pain. Etiologies of ALT include femoral acetabular impingement (FAI) as the most common followed by trauma, degeneration, dysplasia, hypermobility, etc. The fibrocartilaginous acetabular labrum is an important structure in the maintenance of hip perseveration and biomechanics. Several functions include decreasing stress on articular surfaces by increasing surface contact area, maintaining a pressurized layer of intra-articular fluid to distribute mechanical forces, and assisting in joint stability. The consequences of labral pathology are not fully understood, however, prior studies have indicated that there is a correlation between acetabular labral lesions and chondral injury contributing to the development of early degenerative hip disease.
Based on current evidence, it is suggested that the highest degree of clinical accuracy in the diagnosis of a symptomatic acetabular labral tear is with a combination of clinical history, physical examination, advanced imaging such as magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA), and diagnostic injection. Conservative management trials are often considered for initial treatment and include relative rest, activity modification, anti-inflammatory medication, and physical therapy with the potential for intra-articular injections including corticosteroids. If conservative management is unsuccessful, arthroscopic intervention with resection, refixation, or reconstruction is often considered. If conservative management is unsuccessful, arthroscopic intervention with resection, refixation, or reconstruction is often considered.
According to a recent systematic review and meta-analysis, there is promising evidence that platelet rich plasma (PRP) is an effective treatment for hip osteoarthritis. However, there is limited evidence regarding PRP treatment for ALT. To date, there is only one pilot study published evaluating 8 patients diagnosed with ALT who underwent ultrasound guided intra-articular hip injection with PRP. Optimistically, this study did reveal significant differences from baseline in function and pain scores at short term follow-up. However, the study lacked many important details including information about the injectate (the composition of the blood and PRP) which is vital to include in studies of these types. Therefore, the purpose of this study is to fully evaluate the effects of PRP treatment on the clinical outcomes of ALT prospectively in a larger cohort of patients.
- Conditions
- Acetabular Labrum Tear
- Being tested
- PRP
- Keywords
- Acetabular Labrum Tear, Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Intra-articular hip injection of PRP, Blood Collection 45mL, Processed Neutrophil-Poor PRP, 1 injection to one hip joint.
| Study group | Role | What they receive |
|---|---|---|
| Intra-Articular hip injection of PRP | Experimental | Single Group Assignment Recruitment will occur at the University of Utah Orthopedic Center by physician and study staff members medical chart review before patient visits. 45 mL of blood will be collected from eligible participants and processed. A single processed neutrophil-poor PRP injection will be given once to a single hip. Receives: Biological: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment Score
Global patient satisfaction was assessed prospectively at 6 months following the intervention using a numeric rating scale ranging from 0 to 100.
Participants were asked to rate their hip, where 0 represented "worst possible" and 100 represented "best possible."
The score reflects the participant's overall perception of their injection, including symptom improvement and overall experience.
Measured: 6 Months
International Hip Outcome Tool (iHOT-12)
Description:
The International Hip Outcome Tool-12 (iHOT-12) is a validated, patient-reported outcome measure designed to assess symptoms, functional limitations, and quality of life in young, active individuals with hip disorders.
Structure:
The iHOT-12 consists of 12 items that capture four domains:
Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns
Each item is presented as a visual analog scale (VAS).
Scoring:
Each item is scored from 0 to 100. 0 = severe symptoms/extreme limitations 100 = no symptoms/no limitations
The overall score is calculated as the mean of all answered items (range 0-100), with higher scores indicating better hip function and quality of life.
Measured: 6 Months
EQ VAS (EuroQual Visual Analog Scale)
The EQ Visual Analog Scale (EQ VAS) was used to assess participants' self-rated overall health at the primary end-point. Participants rated their health on a scale from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Higher scores indicate better perceived health status.
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 posted27 Mar 2024
- Study start20 Mar 2024
- Primary completion31 Jan 2026
- Study completion1 Mar 2026
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.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acetabular Labrum TearStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Cushman, University of Utah
- Investigators
- Dan Cushman, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332352
- Sponsor's protocol ID
- 00173470
- Acronym
- PRP for ALT
- Status last verified
- Nov 2025
- First submitted
- 1 Mar 2024
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Groh MM, Herrera J. A comprehensive review of hip labral tears. Curr Rev Musculoskelet Med. 2009 Jun;2(2):105-17. doi: 10.1007/s12178-009-9052-9. Epub 2009 Apr 7.
PubMed 19468871Ishoi L, Nielsen MF, Krommes K, Husted RS, Holmich P, Pedersen LL, Thorborg K. Femoroacetabular impingement syndrome and labral injuries: grading the evidence on diagnosis and non-operative treatment-a statement paper commissioned by the Danish Society of Sports Physical Therapy (DSSF). Br J Sports Med. 2021 Nov;55(22):1301-1310. doi: 10.1136/bjsports-2021-104060. Epub 2021 Sep 16.
PubMed 34531185Bsat S, Frei H, Beaule PE. The acetabular labrum: a review of its function. Bone Joint J. 2016 Jun;98-B(6):730-5. doi: 10.1302/0301-620X.98B6.37099.
PubMed 27235512Su T, Chen GX, Yang L. Diagnosis and treatment of labral tear. Chin Med J (Engl). 2019 Jan 20;132(2):211-219. doi: 10.1097/CM9.0000000000000020.
PubMed 30614856McCarthy JC, Noble PC, Schuck MR, Wright J, Lee J. The Otto E. Aufranc Award: The role of labral lesions to development of early degenerative hip disease. Clin Orthop Relat Res. 2001 Dec;(393):25-37. doi: 10.1097/00003086-200112000-00004.
PubMed 11764355Chinzei N, Hashimoto S, Hayashi S, Takayama K, Matsumoto T, Kuroda R. Prediction of intra-articular pathology and arthroscopic outcomes for femoroacetabular impingement and labral tear based on the response to preoperative anaesthetic hip joint injections. Eur J Orthop Surg Traumatol. 2020 May;30(4):737-742. doi: 10.1007/s00590-020-02627-0. Epub 2020 Jan 20.
PubMed 31960159Yoong P, Guirguis R, Darrah R, Wijeratna M, Porteous MJ. Evaluation of ultrasound-guided diagnostic local anaesthetic hip joint injection for osteoarthritis. Skeletal Radiol. 2012 Aug;41(8):981-5. doi: 10.1007/s00256-011-1290-4. Epub 2011 Nov 10.
PubMed 22069031Byrd JW, Jones KS. Diagnostic accuracy of clinical assessment, magnetic resonance imaging, magnetic resonance arthrography, and intra-articular injection in hip arthroscopy patients. Am J Sports Med. 2004 Oct-Nov;32(7):1668-74. doi: 10.1177/0363546504266480.
PubMed 15494331O'Dowd A. Update on the Use of Platelet-Rich Plasma Injections in the Management of Musculoskeletal Injuries: A Systematic Review of Studies From 2014 to 2021. Orthop J Sports Med. 2022 Dec 9;10(12):23259671221140888. doi: 10.1177/23259671221140888. eCollection 2022 Dec.
PubMed 36532150Saied AM, Redant C, El-Batouty M, El-Lakkany MR, El-Adl WA, Anthonissen J, Verdonk R, Audenaert EA. Accuracy of magnetic resonance studies in the detection of chondral and labral lesions in femoroacetabular impingement: systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Feb 16;18(1):83. doi: 10.1186/s12891-017-1443-2.
PubMed 28209142Conaway Wea. Predictors of Outcomes of Non-Surgical Management for Acetabular Labral Tears. Orthopaedic Journal of Sports Medicine. 2018;6(3).
Lim A, Zhu JB, Khanduja V. The Use of Intra-articular Platelet-Rich Plasma as a Therapeutic Intervention for Hip Osteoarthritis: A Systematic Review and Meta-analysis. Am J Sports Med. 2023 Jul;51(9):2487-2497. doi: 10.1177/03635465221095563. Epub 2022 Jun 7.
PubMed 35971803De Luigi AJ, Blatz D, Karam C, Gustin Z, Gordon AH. Use of Platelet-Rich Plasma for the Treatment of Acetabular Labral Tear of the Hip: A Pilot Study. Am J Phys Med Rehabil. 2019 Nov;98(11):1010-1017. doi: 10.1097/PHM.0000000000001237.
PubMed 31162277
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Platelet-Rich Plasma in the Management of Acetabular Labral Tears: a Prospective Study
- ClinicalTrials.gov ID
- NCT06332352
- Acronym / sponsor ID
- PRP for ALT / 00173470
- Conditions
- Acetabular Labrum Tear
- Keywords
- Acetabular Labrum Tear, Platelet Rich Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Posted 25 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function.
Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants.
Detailed description
Acetabular labral tears (ALT) have been reported to have a prevalence of 22-55% in patients presenting with hip or groin pain. Etiologies of ALT include femoral acetabular impingement (FAI) as the most common followed by trauma, degeneration, dysplasia, hypermobility, etc. The fibrocartilaginous acetabular labrum is an important structure in the maintenance of hip perseveration and biomechanics. Several functions include decreasing stress on articular surfaces by increasing surface contact area, maintaining a pressurized layer of intra-articular fluid to distribute mechanical forces, and assisting in joint stability. The consequences of labral pathology are not fully understood, however, prior studies have indicated that there is a correlation between acetabular labral lesions and chondral injury contributing to the development of early degenerative hip disease.
Based on current evidence, it is suggested that the highest degree of clinical accuracy in the diagnosis of a symptomatic acetabular labral tear is with a combination of clinical history, physical examination, advanced imaging such as magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA), and diagnostic injection. Conservative management trials are often considered for initial treatment and include relative rest, activity modification, anti-inflammatory medication, and physical therapy with the potential for intra-articular injections including corticosteroids. If conservative management is unsuccessful, arthroscopic intervention with resection, refixation, or reconstruction is often considered. If conservative management is unsuccessful, arthroscopic intervention with resection, refixation, or reconstruction is often considered.
According to a recent systematic review and meta-analysis, there is promising evidence that platelet rich plasma (PRP) is an effective treatment for hip osteoarthritis. However, there is limited evidence regarding PRP treatment for ALT. To date, there is only one pilot study published evaluating 8 patients diagnosed with ALT who underwent ultrasound guided intra-articular hip injection with PRP. Optimistically, this study did reveal significant differences from baseline in function and pain scores at short term follow-up. However, the study lacked many important details including information about the injectate (the composition of the blood and PRP) which is vital to include in studies of these types. Therefore, the purpose of this study is to fully evaluate the effects of PRP treatment on the clinical outcomes of ALT prospectively in a larger cohort of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-Articular hip injection of PRP | Experimental | Biological: PRPSingle Group Assignment Recruitment will occur at the University of Utah Orthopedic Center by physician and study staff members medical chart review before patient visits. 45 mL of blood will be collected from eligible participants and processed. A single processed neutrophil-poor PRP injection will be given once to a single hip. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≤49 years old (i.e., 18 - 49 years old)
- Hip or groin pain with at least 1 positive provocative labral hip maneuver (i.e., Flexion, Adduction, Internal Rotation (FADIR) test, subspine impingement test, scour)
- Radiographs with Tonnis grade < 2 (i.e., 0 or 1)
- MRI or MRA hip with evidence of acetabular labral tear
- Failure of at least 6 weeks of conservative management [i.e., activity modification, non-steroidal anti-inflammatory drugs (NSAIDs), and/or physical therapy (PT), other intra-articular injection etc.]
Key exclusion criteria (14 listed)
- Any prior surgery to the affected hip
- Imaging with evidence of avascular necrosis of the affected hip
- Imaging with evidence of hip dysplasia (i.e. lateral center edge angle of ≤20 degrees)
- Alpha angle of ≥55 degrees of the affected hip
- Intra-articular hip injection within the last 6 months to the affected hip of any injectate with the exception of anesthetic
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 |
|---|---|---|
| PRPIntra-articular hip injection of PRP, Blood Collection 45mL, Processed Neutrophil-Poor PRP, 1 injection to one hip joint. | Biological | Intra-Articular hip injection of PRP |
Primary outcome
Global Assessment Score
Time frame: 6 Months
Global patient satisfaction was assessed prospectively at 6 months following the intervention using a numeric rating scale ranging from 0 to 100. Participants were asked to rate their hip, where 0 represented "worst possible" and 100 represented "best possible." The score reflects the participant's overall perception of their injection, including symptom improvement and overall experience.
International Hip Outcome Tool (iHOT-12)
Time frame: 6 Months
Description: The International Hip Outcome Tool-12 (iHOT-12) is a validated, patient-reported outcome measure designed to assess symptoms, functional limitations, and quality of life in young, active individuals with hip disorders. Structure: The iHOT-12 consists of 12 items that capture four domains: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns Each item is presented as a visual analog scale (VAS). Scoring: Each item is scored from 0 to 100. 0 = severe symptoms/extreme limitations 100 = no symptoms/no limitations The overall score is calculated as the mean of all answered items (range 0-100), with higher scores indicating better hip function and quality of life.
EQ VAS (EuroQual Visual Analog Scale)
Time frame: 6 Months
The EQ Visual Analog Scale (EQ VAS) was used to assess participants' self-rated overall health at the primary end-point. Participants rated their health on a scale from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Higher scores indicate better perceived health status.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19468871Groh MM, Herrera J. A comprehensive review of hip labral tears. Curr Rev Musculoskelet Med. 2009 Jun;2(2):105-17. doi: 10.1007/s12178-009-9052-9. Epub 2009 Apr 7.
- Background: PubMed 34531185Ishoi L, Nielsen MF, Krommes K, Husted RS, Holmich P, Pedersen LL, Thorborg K. Femoroacetabular impingement syndrome and labral injuries: grading the evidence on diagnosis and non-operative treatment-a statement paper commissioned by the Danish Society of Sports Physical Therapy (DSSF). Br J Sports Med. 2021 Nov;55(22):1301-1310. doi: 10.1136/bjsports-2021-104060. Epub 2021 Sep 16.
- Background: PubMed 27235512Bsat S, Frei H, Beaule PE. The acetabular labrum: a review of its function. Bone Joint J. 2016 Jun;98-B(6):730-5. doi: 10.1302/0301-620X.98B6.37099.
- Background: PubMed 30614856Su T, Chen GX, Yang L. Diagnosis and treatment of labral tear. Chin Med J (Engl). 2019 Jan 20;132(2):211-219. doi: 10.1097/CM9.0000000000000020.
- Background: PubMed 11764355McCarthy JC, Noble PC, Schuck MR, Wright J, Lee J. The Otto E. Aufranc Award: The role of labral lesions to development of early degenerative hip disease. Clin Orthop Relat Res. 2001 Dec;(393):25-37. doi: 10.1097/00003086-200112000-00004.
- Background: PubMed 31960159Chinzei N, Hashimoto S, Hayashi S, Takayama K, Matsumoto T, Kuroda R. Prediction of intra-articular pathology and arthroscopic outcomes for femoroacetabular impingement and labral tear based on the response to preoperative anaesthetic hip joint injections. Eur J Orthop Surg Traumatol. 2020 May;30(4):737-742. doi: 10.1007/s00590-020-02627-0. Epub 2020 Jan 20.
- Background: PubMed 22069031Yoong P, Guirguis R, Darrah R, Wijeratna M, Porteous MJ. Evaluation of ultrasound-guided diagnostic local anaesthetic hip joint injection for osteoarthritis. Skeletal Radiol. 2012 Aug;41(8):981-5. doi: 10.1007/s00256-011-1290-4. Epub 2011 Nov 10.
- Background: PubMed 15494331Byrd JW, Jones KS. Diagnostic accuracy of clinical assessment, magnetic resonance imaging, magnetic resonance arthrography, and intra-articular injection in hip arthroscopy patients. Am J Sports Med. 2004 Oct-Nov;32(7):1668-74. doi: 10.1177/0363546504266480.
- Background: PubMed 36532150O'Dowd A. Update on the Use of Platelet-Rich Plasma Injections in the Management of Musculoskeletal Injuries: A Systematic Review of Studies From 2014 to 2021. Orthop J Sports Med. 2022 Dec 9;10(12):23259671221140888. doi: 10.1177/23259671221140888. eCollection 2022 Dec.
- Background: PubMed 28209142Saied AM, Redant C, El-Batouty M, El-Lakkany MR, El-Adl WA, Anthonissen J, Verdonk R, Audenaert EA. Accuracy of magnetic resonance studies in the detection of chondral and labral lesions in femoroacetabular impingement: systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Feb 16;18(1):83. doi: 10.1186/s12891-017-1443-2.
- BackgroundConaway Wea. Predictors of Outcomes of Non-Surgical Management for Acetabular Labral Tears. Orthopaedic Journal of Sports Medicine. 2018;6(3).
- Background: PubMed 35971803Lim A, Zhu JB, Khanduja V. The Use of Intra-articular Platelet-Rich Plasma as a Therapeutic Intervention for Hip Osteoarthritis: A Systematic Review and Meta-analysis. Am J Sports Med. 2023 Jul;51(9):2487-2497. doi: 10.1177/03635465221095563. Epub 2022 Jun 7.
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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.
Dan Cushman, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP in people with Acetabular Labrum Tear, run by University of Utah 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 6 inclusion and 14 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 25 Jun 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?
Yes. Results are posted in the registry (first posted 25 Jun 2026). 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?
Global Assessment Score (time frame: 6 Months). The study lists 3 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 NCT06332352, which also lists 13 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 25 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.