Peripheral Nerve InjuriesRANGER®NCT01526681
Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction
An observational study of Peripheral Nerve Injuries, run by Axogen Corporation at 49 sites in 4 countries.
Trial summary
This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- Processed Human Nerve Graft, Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc. and Autogenous Nerve Graft
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 3,126 participants
- Where
- 49 sitesin 4 countries
- Study dates
- Nov 2008to Nov 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects surgically repaired with Avance Nerve Graft to reconstruct peripheral nerve discontinuities.
Who may be able to join
- Males and Females who have undergone nerve repair using the Avance® Nerve Graft for the repair of a nerve injury
- Returned for at least one post-operative follow-up visit
- Have nerve transection injuries to the upper extremity;
- Have undergone tension free end to end nerve coaptation on both the proximal and distal portion of the nerve gap with nerve autograft or nerve entubulation with nerve tube conduit at a participating ANG-CP-005 registry site after 2004 and;
- Have completed sufficient follow-up assessments at a regeneration rate of 2mm/day to determine the outcomes of the repair or is willing to comply with site specific post-operative care procedures and assessments to determine the outcome of the repair.
- Female ≥ 18 years old
Show all 16Show fewer
- Undergo post mastectomy autologous breast reconstruction with one type of autologous flap (no stacked reconstructions or use of implant with autologous flap)
- Neurotization must be completed using a donor nerve from the flap and a recipient nerve from the chest
- Complete Sensory Assessment Testing with Semmes Weinstein Monofilaments (SWMF) and the following Breast-Q Questionnaires 60 - 120 days post-reconstruction:
- Breast-Q Physical Well Being of the Chest
- Breast-Q Satisfaction with Breast
- Breast-Q Physical Well Being of the Abdomen
- Breast-Q Abnormal Breast Sensations
- Breast-Q Impact of Breast Sensation on Quality of Life
- Breast-Q Return of Breast Sensation
- Able to provide informed consent and are willing to comply with post-operative care procedures and assessments
Who cannot join
- Subject who in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up.
- Addendum 1 (MATCH) Criteria:
- Direct nerve repairs;
- Nerve gaps greater than 70mm;
- Subjects who, in the opinion of the investigator, were non-compliant to the investigator's post-operative treatment or rehabilitation instructions;
- Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.
Show all 19Show fewer
- Addendum 2 (Sensation-NOW) Criteria:
- Surgical history of secondary revision surgery for partial or total flap loss
- Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)
- Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
- Currently undergoing IV chemotherapy or radiation
- Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule
- Additional Eligibility criteria to Modules
- Module 1: Native Skin Reconstructions with and without neurotization.
- Buried flap reconstructions from nipple sparing mastectomy or skin sparing mastectomy OR a breast reconstruction from a skin sparing mastectomy with exposed flap skin in the peri-areolar region.
- Sensory assessments must be completed on ≥ 8 Zones of Native Skin.
- Center zone measurement may be on either Native Skin or Flap Skin.
- All Inner and Outer zone measurements must be on Native Skin.
- De-identified photo of the breast reconstruction with 9 zones identified.
Trial locations and contacts
49 sites in 4 countries.
49 sites in 4 countries
United States46 sites
RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta
Atlanta, Georgia, 30342
Sensation-NOW: University of Colorado School of Medicine
Aurora, Colorado, 80045
RANGER: Johns Hopkins University
Baltimore, Maryland, 21205
Sensation-NOW: Johns Hopkins University
Baltimore, Maryland, 21287
RANGER: Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
RANGER & MATCH: OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207
RANGER: University of Cincinnati
Cincinnati, Ohio, 45220
Sensation-NOW: University of Cincinnati
Cincinnati, Ohio, 45221
RANGER: Cleveland Clinic
Cleveland, Ohio, 44195
RANGER & MATCH: University of Missouri - Columbia
Columbia, Missouri, 65212
RANGER: Ohio State University Medical Center
Columbus, Ohio, 43210
Sensation-NOW: Ohio State University Medical Center
Columbus, Ohio, 43210
Sensation-NOW: University of Texas Southwestern Medical Center
Dallas, Texas, 75390
RANGER: Duke University
Durham, North Carolina, 27705
RANGER: University of North Texas/John Peter Smith Hospital
Fort Worth, Texas, 76104
Sensation-NOW: University of North Texas/John Peter Smith Hospital
Fort Worth, Texas, 76104
RANGER & MATCH: Campbell Clinic
Germantown, Tennessee, 38138
Sensation-NOW: Baylor College of Medicine
Houston, Texas, 77030
Sensation-NOW: Houston-Methodist Central
Houston, Texas, 77030
Sensation-NOW: Houston-Methodist West/North
Houston, Texas, 77094
RANGER & MATCH: University of Kansas Medical Center
Kansas City, Kansas, 66160
Sensation-NOW: University of Kansas Medical Center
Kansas City, Kansas, 66160
Sensation-NOW: University of Nevada, Las Vegas
Las Vegas, Nevada, 89154
RANGER: University of Kentucky
Lexington, Kentucky, 40506
RANGER: Texas Tech University HSC
Lubbock, Texas, 79430
Sensation-NOW: Advanced Reconstructive Care, LLC
Metairie, Louisiana, 70002
RANGER: University of Miami
Miami, Florida, 33176
MATCH: Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Sensation-NOW: East Cooper Plastic Surgery
Mt. Pleasant, South Carolina, 29464
RANGER & MATCH: Vanderbilt University
Nashville, Tennessee, 37232
Sensation-NOW: Vanderbilt University
Nashville, Tennessee, 37232
Sensation-NOW: University of Nebraska Medical Center
Omaha, Nebraska, 68118
RANGER & MATCH: University of California - Irvine
Orange, California, 92868
Sensation-NOW: University of Pennsylvania
Philadelphia, Pennsylvania, 19104
RANGER & MATCH: Arizona Center for Hand Surgery
Phoenix, Arizona, 85004
RANGER: Phoenix Children's Hospital
Phoenix, Arizona, 85016
Sensation-NOW: Joshua Lemmon, MD, PLLC
Richardson, Texas, 75802
Sensation-NOW: Virginia Commonwealth University
Richmond, Virginia, 23284
RANGER: Multi-Disciplinary Specialists
Rutherford, New Jersey, 07070
RANGER: San Antonio Military Medical Center
San Antonio, Texas, 78231
Sensation-NOW: PRMA Plastic Surgery
San Antonio, Texas, 78240
RANGER & MATCH: The Buncke Clinic
San Francisco, California, 94114
RANGER & MATCH: University of Washington
Seattle, Washington, 98195
Sensation-NOW: Stanford University
Stanford, California, 94305
RANGER & MATCH: Florida Orthopaedic Institute
Tampa, Florida, 33609
Sensation-NOW: George Washington University
Washington D.C., District of Columbia, 20037
United Kingdom1 site
RANGER & MATCH: University Hospital Birmingham, England
Edgbaston, Birmingham, B15 2TH
About this study
Official title: A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair
This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting. Optional addendums 1 and 2 included in the protocol are intended to establish comparative groups and focused subgroups within the registry.
Read the detailed description
This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft.
Addendum 1 (MATCH) establishes a comparative arm to collect data on nerve injuries repaired with nerve autografts and nerve tube conduits at select RANGER® participating sites.
Addendum 2 (Sensation-NOW) establishes a focused arm to collect data on autologous breast reconstructive procedures where neurotization was completed. Post-mastectomy autologous breast reconstruction procedures without neurotization will serve as an internal control group to allow for comparisons.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- Processed Human Nerve Graft, Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc., Autogenous Nerve Graft, Nerve Tube Conduit, Autologous Breast Reconstruction with Neurotization
- Keywords
- Sensory Nerve, Mixed Nerve, Motor Nerve, Neurotization, Nerve Injury, Peripheral Nerve Injury
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed Human Nerve GraftOther
Implantation of appropriate length of processed human nerve graft at the time of surgery
Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.Other
Historical control from established literature
Autogenous Nerve GraftOther
Nerve gap reconstructions with autogenous nerve graft within the upper extremity
Nerve Tube ConduitDevice
Nerve gap reconstructions with nerve tube conduit within the upper extremity
Autologous Breast Reconstruction with NeurotizationProcedure or surgery
Autologous Breast Reconstruction without NeurotizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| RANGER: Avance Nerve Graft | Processed Human Nerve Graft Receives: Other: Processed Human Nerve Graft | |
| Historical Control for Standard Treatment | Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft. Receives: Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc. | |
| MATCH Arm: Contemporary Control | Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit Receives: Other: Autogenous Nerve Graft; Device: Nerve Tube Conduit | |
| Sensation-NOW Arm: Breast Neurotization | Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization Receives: Procedure: Autologous Breast Reconstruction with Neurotization; Procedure: Autologous Breast Reconstruction without Neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events
Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up.
Measured: Through study completion or until lost to follow-up, approximately 3 years
RANGER and MATCH: Sensory Function as measured by Medical Research Council Classification (MRCC) for sensory recovery
Participants will be followed for a change in sensory function, if applicable, of the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care sensory assessments or until lost to follow-up.
Measured: Through study completion or until lost to follow-up, approximately 3 years
RANGER and MATCH: Motor Function as measured by Medical Research Council Classification (MRCC) for motor recovery
Participants will be followed for a change in motor function, if applicable, to the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care motor assessments or until lost to follow-up.
Measured: Through study completion or until lost to follow-up, approximately 3 years
Sensation-NOW- Breast Neurotization: Sensory Function Post Autologous Breast Reconstruction
Participants will be followed for change in sensation through the course of their recovery using Physician's standard of care assessments or until lost to follow-up. Standard of care sensory assessment includes evaluation using Semmes Weinstein Monofilament kit measured in g/mm2.
Measured: Through study completion or until lost to follow-up, approximately 3 years
Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction
Participants will be followed for change in quality of life as measured by Breast Q through the course of their recovery or until lost to follow-up using Physician's standard of care assessments. Standard of care assessments may include evaluation of quality of life via other scales or may be qualitatively documented.
Measured: Through study completion or until lost to follow-up, approximately 3 years
Incidence of conduit, autograft, or procedure related adverse events
Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up.
Measured: Through study completion or until lost to follow-up, approximately 3 years
Secondary outcomes (3)
Pain Level
Participants will be followed for a change in pain level as measured by VAS, when available, through the course of their recovery using Physician's standard of care assessments for pain or until lost to follow-up.
Measured: Through study completion or until lost to follow-up, approximately 3 years
RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve
Participants will be followed for change in quality of life as measured by Disabilities of the Arm Shoulder and Hand Questionnaire (DASH), if available, through the course of their recovery or until lost to follow-up using Physician's standard of care assessments. Standard of care assessments may include evaluation of quality of life via other scales or may be qualitatively documented.
Measured: Through study completion or until lost to follow-up, approximately 3 years
Cost of Care
Participants will be followed for cost of care, as converted to USD, from the surgical nerve procedure through the course of their recovery or until lost to follow-up using available data in the medical record from Physician's standard of care.
Measured: Through study completion or until lost to follow-up, approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startNov 2008
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 3,126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526681
- Sponsor's protocol ID
- ANG-CP-005
- Acronym
- RANGER®
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2012
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair
- ClinicalTrials.gov ID
- NCT01526681
- Acronym / sponsor ID
- RANGER® / ANG-CP-005
- Conditions
- Peripheral Nerve Injuries
- Keywords
- Sensory Nerve, Mixed Nerve, Motor Nerve, Neurotization, Nerve Injury, Peripheral Nerve Injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,126 participants (actual)
- Lead sponsor
- Axogen CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 6 Feb 2012 (estimated)
- 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.
This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting. Optional addendums 1 and 2 included in the protocol are intended to establish comparative groups and focused subgroups within the registry.
Detailed description
This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft.
Addendum 1 (MATCH) establishes a comparative arm to collect data on nerve injuries repaired with nerve autografts and nerve tube conduits at select RANGER® participating sites.
Addendum 2 (Sensation-NOW) establishes a focused arm to collect data on autologous breast reconstructive procedures where neurotization was completed. Post-mastectomy autologous breast reconstruction procedures without neurotization will serve as an internal control group to allow for comparisons.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RANGER: Avance Nerve Graft | – | Other: Processed Human Nerve GraftProcessed Human Nerve Graft |
| Historical Control for Standard Treatment | – | Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft. |
| MATCH Arm: Contemporary Control | – | Other: Autogenous Nerve Graft, Device: Nerve Tube ConduitAddendum 1: Autogenous Nerve Graft and Nerve Tube Conduit |
| Sensation-NOW Arm: Breast Neurotization | – | Procedure: Autologous Breast Reconstruction with Neurotization, Procedure: Autologous Breast Reconstruction without NeurotizationAddendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects surgically repaired with Avance Nerve Graft to reconstruct peripheral nerve discontinuities.
Key inclusion criteria (16 listed)
- Males and Females who have undergone nerve repair using the Avance® Nerve Graft for the repair of a nerve injury
- Returned for at least one post-operative follow-up visit
- Have nerve transection injuries to the upper extremity;
- Have undergone tension free end to end nerve coaptation on both the proximal and distal portion of the nerve gap with nerve autograft or nerve entubulation with nerve tube conduit at a participating ANG-CP-005 registry site after 2004 and;
- Have completed sufficient follow-up assessments at a regeneration rate of 2mm/day to determine the outcomes of the repair or is willing to comply with site specific post-operative care procedures and assessments to determine the outcome of the repair.
Key exclusion criteria (19 listed)
- Subject who in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up.
- Direct nerve repairs;
- Nerve gaps greater than 70mm;
- Subjects who, in the opinion of the investigator, were non-compliant to the investigator's post-operative treatment or rehabilitation instructions;
- Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.
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 |
|---|---|---|
| Processed Human Nerve GraftImplantation of appropriate length of processed human nerve graft at the time of surgery | Other | RANGER: Avance Nerve Graft |
| Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.Historical control from established literature | Other | Historical Control for Standard Treatment |
| Autogenous Nerve GraftNerve gap reconstructions with autogenous nerve graft within the upper extremity | Other | MATCH Arm: Contemporary Control |
| Nerve Tube ConduitNerve gap reconstructions with nerve tube conduit within the upper extremity | Device | MATCH Arm: Contemporary Control |
| Autologous Breast Reconstruction with Neurotization | Procedure or surgery | Sensation-NOW Arm: Breast Neurotization |
| Autologous Breast Reconstruction without Neurotization | Procedure or surgery | Sensation-NOW Arm: Breast Neurotization |
Primary outcome
Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events
Time frame: Through study completion or until lost to follow-up, approximately 3 years
Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up.
RANGER and MATCH: Sensory Function as measured by Medical Research Council Classification (MRCC) for sensory recovery
Time frame: Through study completion or until lost to follow-up, approximately 3 years
Participants will be followed for a change in sensory function, if applicable, of the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care sensory assessments or until lost to follow-up.
RANGER and MATCH: Motor Function as measured by Medical Research Council Classification (MRCC) for motor recovery
Time frame: Through study completion or until lost to follow-up, approximately 3 years
Participants will be followed for a change in motor function, if applicable, to the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care motor assessments or until lost to follow-up.
Sensation-NOW- Breast Neurotization: Sensory Function Post Autologous Breast Reconstruction
Time frame: Through study completion or until lost to follow-up, approximately 3 years
Participants will be followed for change in sensation through the course of their recovery using Physician's standard of care assessments or until lost to follow-up. Standard of care sensory assessment includes evaluation using Semmes Weinstein Monofilament kit measured in g/mm2.
Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction
Time frame: Through study completion or until lost to follow-up, approximately 3 years
Participants will be followed for change in quality of life as measured by Breast Q through the course of their recovery or until lost to follow-up using Physician's standard of care assessments. Standard of care assessments may include evaluation of quality of life via other scales or may be qualitatively documented.
Incidence of conduit, autograft, or procedure related adverse events
Time frame: Through study completion or until lost to follow-up, approximately 3 years
Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up.
3 secondary outcomes
Pain Level
Time frame: Through study completion or until lost to follow-up, approximately 3 years
RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve
Time frame: Through study completion or until lost to follow-up, approximately 3 years
Cost of Care
Time frame: Through study completion or until lost to follow-up, approximately 3 years
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 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injuries, run by Axogen Corporation at 49 sites in 4 countries.
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 16 inclusion and 19 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Austria, Canada, United Kingdom. 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?
Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events (time frame: Through study completion or until lost to follow-up, approximately 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.