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Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRE Treatment Arm | Experimental | All patients enrolled in this trial will receive IRE treatment with the NanoKnife System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible Electroporation | Device | IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Negative In-field Biopsy at 12 Months | Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months | 12 months |
| Number of Participants With Device-related Adverse Events Through 12 Months | Number of participants who experienced any adverse event related to the study device during the study | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Negative In-field Biopsy at 12 Months as Defined by the Delphi Consensus Criterion | Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months, as defined by the Delphi consensus criterion of absence of clinically significant disease (where ≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is considered insignificant) |
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Inclusion Criteria:
Exclusion Criteria:
Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
Is unfit for anesthesia or has a contraindication for agents listed for paralysis
Has an active urinary tract infection (UTI)
Has a history of bladder neck contracture
Is interested in future fertility
Has a history (within 3 years) of inflammatory bowel disease
Has a concurrent major debilitating illness
Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
Has any active implanted electronic device (e.g., pacemaker)
Is unable to catheterize due to a urethral stricture disease
Has had prior or current prostate cancer therapies:
Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
Has had prior major rectal surgery (except hemorrhoids)
Is unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute significant image artifacts, allergy or contraindication to gadolinium (to enhance MRI))
Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder
Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons
In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual (section 2.3)
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Coleman, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Arvin George, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| University of Colorado |
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| ID | Title | Description |
|---|---|---|
| FG000 | NanoKnife System | All patients enrolled in this trial will receive IRE treatment with the NanoKnife System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2023 |
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| 12 months |
| Assessment of Urinary Function by Comparison of Pre- and Post-operative UCLA Expanded Prostate Cancer Index Composite | Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite (UCLA-EPIC) Urinary Domain (range from 0-100 with higher scores representing better quality of life) and International Prostate Symptom Scores (IPSS) (range from 0 to 35 (asymptomatic to very symptomatic)) and IPSS Quality of Life (IPSS-QoL) scores (range from zero (0) indicating Delighted to six (6) indicating Terrible), change from Baseline to 12 Months | 12 months |
| Assessment of Erectile Function by Comparison of Pre- and Post-operative IIEF-15 Potency Scores | Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores, change from Baseline to 12 Months (range 0 - 75, higher scores indicate less dysfunction/higher satisfaction) | 12 months |
| Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics | Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, including PSA nadir | 12 months |
| Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics, Percent Change From Baseline | Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, percent change from baseline | 12 months |
| Assessment of Changes in Prostate Volume | Assessment of percent change in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI. | 12 months |
| Assessment of Ablation Effectiveness by Evaluation of Prostate Tissue by mpMRI | Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI at 12 months post-treatment, using the PI-RADS scoring system, a 1-to-5 scale used on prostate MRI to indicate the likelihood of clinically significant prostate cancer, with higher scores suggesting greater suspicion of cancer. | 12 months |
| Assessment of Need for Secondary or Adjuvant Treatment | Assessment of need for secondary or adjuvant treatment following treatment with the NanoKnife System. | 12 months |
| Evaluation of Subject Reported Pre- and Post-operative Quality of Life, Change From Baseline to 12 Months | Evaluation of subject reported pre- and post-operative Quality of Life (QoL) using the 5-dimension scale EuroQoL (EQ-5D®) EQ VAS. Scale ranges from minimum of 0 (worse) to 100 (better/best). | 12 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Florida Health | Gainesville | Florida | 32610 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Northshore University Healthsystem | Evanston | Illinois | 60201 | United States |
| Duly Health and Care | Lisle | Illinois | 60532 | United States |
| VA Ann Arbor Health Care | Ann Arbor | Michigan | 48105 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| NYU Langone Health | New York | New York | 10017 | United States |
| Northwell Health | New York | New York | 10022 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45221 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| COMPLETED |
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| NOT COMPLETED |
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ITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | IRE Treatment Arm | All patients enrolled in this trial will receive IRE treatment with the NanoKnife System Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Negative In-field Biopsy at 12 Months | Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months | ITT Population, n=14 subjects with missing biopsy information at 12 months were imputed as positive. | Posted | Count of Participants | Participants | 12 months |
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| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Device-related Adverse Events Through 12 Months | Number of participants who experienced any adverse event related to the study device during the study | ITT Population | Posted | Count of Participants | Participants | 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Negative In-field Biopsy at 12 Months as Defined by the Delphi Consensus Criterion | Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months, as defined by the Delphi consensus criterion of absence of clinically significant disease (where ≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is considered insignificant) | ITT, including subjects with biopsy data available at 12 months or who had a positive in-field biopsy prior to 12 months (i.e., no imputation performed for subjects missing biopsy information post-treatment) | Posted | Count of Participants | Participants | 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Assessment of Urinary Function by Comparison of Pre- and Post-operative UCLA Expanded Prostate Cancer Index Composite | Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite (UCLA-EPIC) Urinary Domain (range from 0-100 with higher scores representing better quality of life) and International Prostate Symptom Scores (IPSS) (range from 0 to 35 (asymptomatic to very symptomatic)) and IPSS Quality of Life (IPSS-QoL) scores (range from zero (0) indicating Delighted to six (6) indicating Terrible), change from Baseline to 12 Months | ITT Population, patients with available scores (completed questionnaire) at baseline and at 12 months | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Assessment of Erectile Function by Comparison of Pre- and Post-operative IIEF-15 Potency Scores | Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores, change from Baseline to 12 Months (range 0 - 75, higher scores indicate less dysfunction/higher satisfaction) | ITT Population, patients with available scores (completed questionnaire) at baseline and at 12 months | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics | Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, including PSA nadir | ITT Population, patients with available PSA at baseline and at 12 months | Posted | Median | Inter-Quartile Range | ng/mL | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics, Percent Change From Baseline | Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, percent change from baseline | ITT Population, patients with available PSA at baseline and at 12 months | Posted | Median | Inter-Quartile Range | % change | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Assessment of Changes in Prostate Volume | Assessment of percent change in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI. | ITT Population, patients with available prostate volume at baseline and at 12 months | Posted | Mean | Standard Deviation | % change | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Assessment of Ablation Effectiveness by Evaluation of Prostate Tissue by mpMRI | Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI at 12 months post-treatment, using the PI-RADS scoring system, a 1-to-5 scale used on prostate MRI to indicate the likelihood of clinically significant prostate cancer, with higher scores suggesting greater suspicion of cancer. | ITT Population, patients with available MRI imaging at baseline and at 12 months | Posted | Count of Participants | Participants | 12 months |
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| |||||||||||||||||||||||||||||
| Secondary | Assessment of Need for Secondary or Adjuvant Treatment | Assessment of need for secondary or adjuvant treatment following treatment with the NanoKnife System. | ITT Population | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Evaluation of Subject Reported Pre- and Post-operative Quality of Life, Change From Baseline to 12 Months | Evaluation of subject reported pre- and post-operative Quality of Life (QoL) using the 5-dimension scale EuroQoL (EQ-5D®) EQ VAS. Scale ranges from minimum of 0 (worse) to 100 (better/best). | ITT Population, patients with available scores (completed questionnaire) at baseline and at 12 months | Posted | Mean | Standard Deviation | score on a scale, change from baseline | 12 months |
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12 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IRE Treatment Arm | All patients enrolled in this trial will receive IRE treatment with the NanoKnife System Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes. | 1 | 121 | 11 | 121 | 100 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Disease progression | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Chills | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Rectourethral fistula | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Biopsy bladder | Investigations | MedDRA (24.1) | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA (24.1) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (24.1) | Systematic Assessment |
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| Haematospermia | Reproductive system and breast disorders | MedDRA (24.1) | Systematic Assessment |
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| Penile pain | Reproductive system and breast disorders | MedDRA (24.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Manning | AngioDynamics, Inc. | 339-237-2765 | liz.manning@angiodynamics.com |
| Apr 17, 2026 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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