Localized Intermediate Risk Prostate LesionsNCT01657942
Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
A study testing ExAblate MR Guided Focused Ultrasound in people with Localized Intermediate Risk Prostate Lesions, run by InSightec at 9 sites in United States.
Trial summary
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Localized Intermediate Risk Prostate Lesions
- What is being tested?
- ExAblate MR Guided Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2013to May 2021
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven adenocarcinoma of the prostate (using a IMAGE-guided 14+ core mapping biopsy), and targeted cores as needed obtained up to 6 months prior to scheduled treatment
- Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
- Patient with PSA less than or equal to 20 ng/mL
- Gleason score 7 (4 + 3 or 3 + 4), based on mapping prostate biopsy, with no more than 15mm cancer in maximal linear dimension in any single core
- Single hemilateral index Gleason 7 lesion, identified in the prostate based on biopsy mapping with supporting MRI; may have secondary Gleason 6 lesion on ipsilateral or contralateral side confirmed with biopsy and/or MRI
Who cannot join
- Contraindications to MRI
- History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy
- Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs. sonication time)
- Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe probe insertion (e.g., stenosis, fibrosis, inflammatory bowel disease, etc.)
- Evidence of distant prostate cancer, i.e., including lymph nodes and/or metastasis of cancer on imaging
Show all 10Show fewer
- Bladder cancer
- Urethral stricture/bladder neck contracture
- Prostatitis NIH categories I, II and III
- Implant near (<1 cm) the prostate
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
University of Virginia
Charlottesville, Virginia, 22908
Sperling Prostate Center
Delray Beach, Florida, 33445
City of Hope
Duarte, California, 91010
University of California Los Angeles
Los Angeles, California, 90095
Weill Cornell Medical Center
New York, New York, 10021
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
Stanford University School of Medicine
Stanford, California, 94305
About this study
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.
Read the detailed description
Objective of this pivotal trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of intermediate risk, localized (organ confined) prostate lesions.
ExAblate treatment will be implemented as a focal lesion-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, identified by mapping biopsy and multi-parametric MRI, rather than a whole gland or hemi-ablation treatment.
Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of intermediate risk organ confined prostate lesions. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.
Effectiveness: determine the lesion control effect of ExAblate's MRgFUS focal treatment of intermediate risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).
- Being tested
- ExAblate MR Guided Focused Ultrasound
- Keywords
- MRgFUS, Prostate, Intermediate Risk Prostate Lesions, Focal Prostate treatment, InSightec, ExAblate, Non-invasive, Prostate cancer, Gleason 7
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate MR Guided Focused UltrasoundDevice
Also called ExAblate 2100 Prostate System
ExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.
| Study group | Role | What they receive |
|---|---|---|
| ExABlate MR Guided Focus Ultrasound | Experimental | ExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy. Receives: Device: ExAblate MR Guided Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Device and Procedure Related Adverse Events
The cumulative sum of adverse events was followed through Month 12 of the study.
Measured: 12 months Post Treatment
Percentage of Subjects With NO Gleason Grade Group (GGG) Tissue in the Planned Region of Treatment (ROT) at 6 Months.
The first primary effectiveness endpoint is within area of treatment (Region of Treatment, ROT) prostate biopsy occurring at 6-months post-treatment. Positive biopsy was defined as any Gleason Grade Group (GGG) tissue identified within the area of planned Exablate ROT. Negative biopsy was defined No Gleason Grade Group (GGG) tissue within the area of planned ROT.
Measured: 6 Months Post Treatment
Percentage of Subjects Showing a Reduction in PSA Value (Prostate Specific Antigen) From Baseline to 6-Months
The second primary effectiveness endpoint is the percentage of subjects experiencing a reduction in PSA value (Prostate Specific Antigen) from baseline to 6-months post-treatment. PSA values that increased or remained the same were considered an increase. Increased Prostate Specific Antigen levels in the blood is a common indication of prostate cancer.
PSA results at 6 months - Value of ≤ 10ng/mL (Yes/No)
Measured: 6-months Post Treatment
Percentage of Subjects With Non-Perfused Volume (NPV) Entirely Covered Target Gleason Grade Group (GGG) Tissue at Treatment.
The final primary effectiveness endpoint is percentage of subjects with NPV complete coverage of targeted Gleason tissue at treatment. NPV (non-perfused volume) is the volume of tissue ablated/treated, a measure of the completeness/effectiveness of the ablation.
Measured: 6 Months Post Treatment
Secondary outcomes (8)
Prostate Specific Antigen (PSA)
Prostate Specific Antigen (PSA) concentration in the blood is commonly measured to screen for prostate cancer. Prostate Specific Antigen (PSA) was reported as a primary endpoint. Here it is presented to show levels at 6 Months and 12 Months post-treatment compared to Baseline (pre-treatment). Elevated PSA suggests potential cancer.
Measured: Baseline, 6 Months, 12 Months
Functional Assessment of Cancer Therapy - General (Fact-G) Total Score
The total FACT-G score ranges from 0 to 108 and is the summation of 4 subscale scores. The subscale scores are added to obtain the total score, which is calculated using a five-point scale from 0 (not at all) to 4 (very much). A higher FACT-G score indicates better overall well-being and quality of life. The FACT-G is an alternative scoring method to the Trial Outcome Index (TOI) which is also reported in this study.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score
The Fact-P Total Score (Score range: 0-156) is a comprehensive multidimensional quality of life measure designed specifically for patients with prostate cancer. It is a 39-item assessment in a 5-point (0-4) Likert-type Scale. Higher scores represent better symptomology, functioning and quality of life.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI)
Functional Assessment of Cancer Therapy - P (Fact-P) Trial Outcomes Index (TOI, Score range: 1-104). An alternative scoring method to the Fact-G Total is the Trial Outcome Index (TOI), which is the sum of the Physical, Functional, and Lung Cancer Subscales. The TOI is reported to be an efficient and precise summary index of physical and functional outcomes. Higher scores indicate less symptomology and better physical and functional outcomes.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score
Urinary incontinence (ICIQ) Total Score (Score range: 0-21) is a simple questionnaire for evaluating the frequency, severity, and impact of urinary incontinence. High scores indicate greater impairment. Lower scores indicate better outcomes. This questionnaire assesses urinary incontinence and its impact on quality of life (QoL). So, a lower score implies less frequent and less severe incontinence, which is generally considered favorable.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
International Prostate Symptom Score (IPSS Total Score)
High scores indicate worse symptomology. The total I-PSS score can range from 0 (asymptomatic) to 35 (very symptomatic). Additionally, there's a question about quality of life due to urinary symptoms, where patients rate their feelings from "delighted" to "terrible" regarding their current condition. This assessment helps clinicians understand the severity of BPH symptoms and guide treatment decisions.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
International Prostate Symptom Score (IPSS) - Quality of Life Score
IPSS Urinary Symptoms (IPSS-QoL Score range: 0-5). Question 7 of the IPSS, the Quality-of-Life question, is "7. Nocturia: How many times do you typically get up at night to urinate? (Select from 0 to 5)." Zero (0) suggests no interference with sleep and 5 suggests greater interference with sleep. Thus, high scores indicate worse quality of life.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction
IIEF-15 Erectile Dysfunction Overall Satisfaction (IIEF-15 Overall Satisfaction range: 0-10). Low scores are worse.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startOct 2013
- Primary completionOct 2019
- Study completionMay 2021
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 (2)Papers the sponsor has linked to this study.
- Other trials for Localized Intermediate Risk Prostate LesionsStudies of the same condition, open and under way.
- More trials run by InSightecThe 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Behfar Ehdaie, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657942
- Sponsor's protocol ID
- PCa003
- Status last verified
- Oct 2024
- First submitted
- 2 Aug 2012
- Last updated
- 13 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bitton RR, Shao W, Chodakeiwitz Y, Brunsing RL, Sonn G, Rusu M, Ghanouni P. Intraprocedural Diffusion-weighted Imaging for Predicting Ablation Zone during MRI-guided Focused Ultrasound of Prostate Cancer. Radiol Imaging Cancer. 2024 Sep;6(5):e240009. doi: 10.1148/rycan.240009.
PubMed 39212524Ehdaie B, Tempany CM, Holland F, Sjoberg DD, Kibel AS, Trinh QD, Durack JC, Akin O, Vickers AJ, Scardino PT, Sperling D, Wong JYC, Yuh B, Woodrum DA, Mynderse LA, Raman SS, Pantuck AJ, Schiffman MH, McClure TD, Sonn GA, Ghanouni P. MRI-guided focused ultrasound focal therapy for patients with intermediate-risk prostate cancer: a phase 2b, multicentre study. Lancet Oncol. 2022 Jul;23(7):910-918. doi: 10.1016/S1470-2045(22)00251-0. Epub 2022 Jun 14.
PubMed 35714666
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
- ClinicalTrials.gov ID
- NCT01657942
- Acronym / sponsor ID
- PCa003
- Keywords
- MRgFUS, Prostate, Intermediate Risk Prostate Lesions, Focal Prostate treatment, InSightec, ExAblate, Non-invasive, Prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Posted 13 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.
Detailed description
Objective of this pivotal trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of intermediate risk, localized (organ confined) prostate lesions.
ExAblate treatment will be implemented as a focal lesion-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, identified by mapping biopsy and multi-parametric MRI, rather than a whole gland or hemi-ablation treatment.
Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of intermediate risk organ confined prostate lesions. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.
Effectiveness: determine the lesion control effect of ExAblate's MRgFUS focal treatment of intermediate risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExABlate MR Guided Focus Ultrasound | Experimental | Device: ExAblate MR Guided Focused UltrasoundExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy proven adenocarcinoma of the prostate (using a IMAGE-guided 14+ core mapping biopsy), and targeted cores as needed obtained up to 6 months prior to scheduled treatment
- Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
- Patient with PSA less than or equal to 20 ng/mL
- Gleason score 7 (4 + 3 or 3 + 4), based on mapping prostate biopsy, with no more than 15mm cancer in maximal linear dimension in any single core
- Single hemilateral index Gleason 7 lesion, identified in the prostate based on biopsy mapping with supporting MRI; may have secondary Gleason 6 lesion on ipsilateral or contralateral side confirmed with biopsy and/or MRI
Key exclusion criteria (10 listed)
- Contraindications to MRI
- History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy
- Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs. sonication time)
- Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe probe insertion (e.g., stenosis, fibrosis, inflammatory bowel disease, etc.)
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 |
|---|---|---|
| ExAblate MR Guided Focused UltrasoundAlso: ExAblate 2100 Prostate SystemExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy. | Device | ExABlate MR Guided Focus Ultrasound |
Primary outcome
Number of Device and Procedure Related Adverse Events
Time frame: 12 months Post Treatment
The cumulative sum of adverse events was followed through Month 12 of the study.
Percentage of Subjects With NO Gleason Grade Group (GGG) Tissue in the Planned Region of Treatment (ROT) at 6 Months.
Time frame: 6 Months Post Treatment
The first primary effectiveness endpoint is within area of treatment (Region of Treatment, ROT) prostate biopsy occurring at 6-months post-treatment. Positive biopsy was defined as any Gleason Grade Group (GGG) tissue identified within the area of planned Exablate ROT. Negative biopsy was defined No Gleason Grade Group (GGG) tissue within the area of planned ROT.
Percentage of Subjects Showing a Reduction in PSA Value (Prostate Specific Antigen) From Baseline to 6-Months
Time frame: 6-months Post Treatment
The second primary effectiveness endpoint is the percentage of subjects experiencing a reduction in PSA value (Prostate Specific Antigen) from baseline to 6-months post-treatment. PSA values that increased or remained the same were considered an increase. Increased Prostate Specific Antigen levels in the blood is a common indication of prostate cancer. PSA results at 6 months - Value of ≤ 10ng/mL (Yes/No)
Percentage of Subjects With Non-Perfused Volume (NPV) Entirely Covered Target Gleason Grade Group (GGG) Tissue at Treatment.
Time frame: 6 Months Post Treatment
The final primary effectiveness endpoint is percentage of subjects with NPV complete coverage of targeted Gleason tissue at treatment. NPV (non-perfused volume) is the volume of tissue ablated/treated, a measure of the completeness/effectiveness of the ablation.
8 secondary outcomes
Prostate Specific Antigen (PSA)
Time frame: Baseline, 6 Months, 12 Months
Functional Assessment of Cancer Therapy - General (Fact-G) Total Score
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
International Prostate Symptom Score (IPSS Total Score)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
International Prostate Symptom Score (IPSS) - Quality of Life Score
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39212524Bitton RR, Shao W, Chodakeiwitz Y, Brunsing RL, Sonn G, Rusu M, Ghanouni P. Intraprocedural Diffusion-weighted Imaging for Predicting Ablation Zone during MRI-guided Focused Ultrasound of Prostate Cancer. Radiol Imaging Cancer. 2024 Sep;6(5):e240009. doi: 10.1148/rycan.240009.
- Derived from this study: PubMed 35714666Ehdaie B, Tempany CM, Holland F, Sjoberg DD, Kibel AS, Trinh QD, Durack JC, Akin O, Vickers AJ, Scardino PT, Sperling D, Wong JYC, Yuh B, Woodrum DA, Mynderse LA, Raman SS, Pantuck AJ, Schiffman MH, McClure TD, Sonn GA, Ghanouni P. MRI-guided focused ultrasound focal therapy for patients with intermediate-risk prostate cancer: a phase 2b, multicentre study. Lancet Oncol. 2022 Jul;23(7):910-918. doi: 10.1016/S1470-2045(22)00251-0. Epub 2022 Jun 14.
- 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.
Behfar Ehdaie, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate MR Guided Focused Ultrasound in people with Localized Intermediate Risk Prostate Lesions, run by InSightec at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 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 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 13 Nov 2024). 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?
Number of Device and Procedure Related Adverse Events (time frame: 12 months Post Treatment). The study lists 4 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 NCT01657942, which also lists 2 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 13 Nov 2024.