Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with HydroPearl via radial access | all patients will be in the same group/cohort in this open-label, single-arm, observational registry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with HydroPearl via radial access | Device | This is an observational study collecting data on patients who are already being treated with HydroPearl on-label per standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | Defined as completing the planned procedure without femoral access bailout | Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure)) |
| Technical Success | Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization | Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed) |
| Freedom From Major Adverse Events and Radial Access Complications | Major Adverse Events are defined as the following: Death MI Stroke | within 30 days post-procedure |
| Radial Access Related Complications Within 30 Days | Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure | 30 days post procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
This is a prospective, multi-center, registry study to assess the procedural success, technical success, and complication rate of radial access procedures using HydroPearl microspheres.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marcelo Guimaraes, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Los Angeles | Los Angeles | California | 90095 | United States | ||
| Rush University Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Uterine Fibroid Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Uterine Fibroid Embolization (UFE) All subjects will receive treatment with HydroPearl via radial access. |
| FG001 | Prostatic Artery Embolization With HydroPearls Via Radial Access |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Jan 15, 2021 |
Not provided
Not provided
Not provided
Not provided
| Chicago |
| Illinois |
| 60612 |
| United States |
| SLU Department of Radiology | St Louis | Missouri | 63110 | United States |
| Mount Sinai | New York | New York | 11766 | United States |
| UNC | Chapel Hill | North Carolina | 27599 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
Patients will be separated into the following groups based on indication: Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH). All subjects will receive treatment with HydroPearls via radial access. |
| FG002 | Liver Tumor Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Liver Tumor Embolization (LT) to hypervascular tumors in the liver. All subjects will receive treatment with HydroPearls via radial access. |
| FG003 | Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver. All subjects will receive treatment with HydroPearls via radial access. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Uterine Fibroid Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Uterine Fibroid Embolization (UFE) All subjects will receive treatment with HydroPearl via radial access. |
| BG001 | Prostatic Artery Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH). All subjects will receive treatment with HydroPearls via radial access. |
| BG002 | Liver Tumor Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Liver Tumor Embolization (LT) to hypervascular tumors in the liver. All subjects will receive treatment with HydroPearls via radial access. |
| BG003 | Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver. All subjects will receive treatment with HydroPearls via radial access. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Medical History | Count of Participants | Participants |
|
| 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 | Procedural Success | Defined as completing the planned procedure without femoral access bailout | Posted | Count of Participants | Participants | Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure)) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Technical Success | Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization | Posted | Count of Participants | Participants | Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Freedom From Major Adverse Events and Radial Access Complications | Major Adverse Events are defined as the following: Death MI Stroke | Posted | Count of Participants | Participants | within 30 days post-procedure |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Radial Access Related Complications Within 30 Days | Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure | Posted | Count of Participants | Participants | 30 days post procedure |
|
Within 30 days of index procedure
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Uterine Fibroid Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Uterine Fibroid Embolization (UFE) All subjects will receive treatment with HydroPearl via radial access. | 1 | 70 | 6 | 70 | 32 | 70 |
| EG001 | Prostatic Artery Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH). All subjects will receive treatment with HydroPearls via radial access. | 0 | 16 | 0 | 16 | 9 | 16 |
| EG002 | Liver Tumor Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Liver Tumor Embolization (LT) to hypervascular tumors in the liver. All subjects will receive treatment with HydroPearls via radial access. | 1 | 7 | 1 | 7 | 4 | 7 |
| EG003 | Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver. All subjects will receive treatment with HydroPearls via radial access. | 0 | 6 | 2 | 6 | 3 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Acute hypoxic respiratory failure - not related to technique or device |
|
| Death | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment | End stage liver disease - not related to procedure or device |
|
| Blood loss anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Corona Virus | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Post-procedural complication | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Enterococcal bacteremia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vascular access site hematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vascular access site bruising | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Vascular access site pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Bladder Spasm | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Genital paraesthesia | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pharyngeal hematoma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Arterial Spasm | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Post embolization syndrome | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Vascular access site erythema | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vasospasm | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paige Gowen | Clinical Project Manager | 908-208-3749 | paige.gowen@terumomedical.com |
| Aug 8, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D001165 | Arteriovenous Malformations |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Atrial Fibrillation |
|
| Hypertension |
|
| Hypercholesterolemia |
|
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access |
Patients will be separated into the following groups based on indication: Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver. All subjects will receive treatment with HydroPearls via radial access. |
|
|
Patients will be separated into the following groups based on indication: Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver. All subjects will receive treatment with HydroPearls via radial access. |
|
|
| OG003 | Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Patients will be separated into the following groups based on indication: Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver. All subjects will receive treatment with HydroPearls via radial access. |
|
|