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A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents
A multi-center registry study to obtain post-market clinical data on safety and effectiveness of the Boston Scientific Ureteral and Urinary Diversion Stents
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Ureteral Stents, Urinary Diversion Stent | Device | A BSC Ureteral Stent is an implantable device that is used to restore flow of urine from the kidney to the bladder in obstructed ureters. A BSC Urinary Diversion Stent is an implantable device that is used to restore flow of urine from the kidney. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Implanted Stents Meeting the Technical Success Criteria | Technical success was defined as: a stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters. | 2 months to 15 Months |
| Primary Safety Endpoint | Any Serious Adverse Device Effects | 2 months to 15 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life - Patient-Reported Outcomes | Measurement System Patient Reported Outcomes Measurement Information System (PROMIS®) for subjects ≥18 years
Higher PROMIS score means worse quality of life |
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Inclusion Criteria (for all Ureteral stent types except Urinary Diversion Stents):
Subject is undergoing placement of a Boston Scientific Ureteral Stent
Subject anatomy is appropriate to accommodate a stent size available in the study
Subject is able to accurately detect and report bladder function and pain
Subject is willing and able to:
Inclusion Criteria (for Urinary Diversion Stents):
Exclusion Criteria (for Ureteral stents and Urinary Diversion Stents):
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Study will enroll patients who are receiving a Boston Scientific Ureteral stent or Urinary Diversion Stent as part of their standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| Amy Krambeck | Northwestern University | Principal Investigator |
| Michael Borofsky | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Phoenix | Phoenix | Arizona | 85054 | United States | ||
| Northwestern University-Department of Urology |
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This section is not applicable.
Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Boston Scientific Tria Ureteral Stents | Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study. |
| FG001 | Boston Scientific Non- Tria Ureteral Stents | Subjects were treated with Non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
20 Non-Tria subjects were screen failures and did not complete the Index Procedure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Boston Scientific Ureteral Stents - Tria | Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Implanted Stents Meeting the Technical Success Criteria | Technical success was defined as: a stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters. | Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included. Number of units analyzed are stents implanted for more than 12 hours. Results were summarized by Tria and Non-Tria separately. Performance goal was 85% for Tria stone management. | Posted | Count of Units | Stent Implanted | 2 months to 15 Months | Stent Implanted | Stent Implanted |
|
up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled.
AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious)
SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
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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 | Boston Scientific Ureteral Stents - Tria | Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Boston Scientific | 5133058628 | teresa.takle-flach@bsci.com |
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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 | Sep 15, 2021 | Aug 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014517 | Ureteral Obstruction |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Change From Index Procedure to Stent Removal Visit; Change From Index Procedure to Post Stent Removal Visit Stent Removal: Typically, within 2 weeks to < 365 days from Index Procedure Post-Stent Removal: Typically, 3 - 12 weeks from Stent Removal |
| Stent Migration | Stent Migration: Confirmed via imaging | 2 months to 15 Months |
| Chicago |
| Illinois |
| 60611 |
| United States |
| NorthShore University HealthSystem | Glenview | Illinois | 60026 | United States |
| Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| New York Presbyterian Hospital-Columbia University Medical Center | New York | New York | 10032 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Centre Hospit Prive St Gregoire Vivalto | Saint-Grégoire | 35760 | France |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| Death |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Discontinued. Patient had disseminated metastatic condition |
|
| Screen Failure |
|
| BG001 | Boston Scientific Ureteral Stents - Non-Tria | Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Quality of Life Endpoint - Patient-Reported Outcomes | Pain Interference 6b: score range is 41.0 to 78.3; with higher values being worse quality of life. Pain Intensity 3a: score range is 30.7 to 71.8; with higher values being worse quality of life. | Mean | Full Range | units on a scale |
|
| OG001 | Boston Scientific Ureteral Stents - Non-Tria | Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study. |
|
|
|
| Primary | Primary Safety Endpoint | Any Serious Adverse Device Effects | Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included. | Posted | Count of Participants | Participants | 2 months to 15 Months |
|
|
|
| Secondary | Quality of Life - Patient-Reported Outcomes | Measurement System Patient Reported Outcomes Measurement Information System (PROMIS®) for subjects ≥18 years
Higher PROMIS score means worse quality of life | Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included. | Posted | Mean | Full Range | score on a scale | Change From Index Procedure to Stent Removal Visit; Change From Index Procedure to Post Stent Removal Visit Stent Removal: Typically, within 2 weeks to < 365 days from Index Procedure Post-Stent Removal: Typically, 3 - 12 weeks from Stent Removal |
|
|
|
| Secondary | Stent Migration | Stent Migration: Confirmed via imaging | Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included. Number of units analyzed are for all stents implanted. | Posted | Count of Units | Stent Implanted | 2 months to 15 Months | Stent Implanted | Stent Implanted |
|
|
|
| 3 |
| 215 |
| 9 |
| 215 |
| 57 |
| 215 |
| EG001 | Boston Scientific Ureteral Stents - Non-Tria | Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study. | 0 | 144 | 5 | 144 | 40 | 144 |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis Acute | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary Tract Infections | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Urinary Bladder Haemorrhage | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac Valve Disease | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Prostate Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Renal Pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bladder Spasm | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Micturition Disorder | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Micturition Urgency | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Pain | General disorders | MedDRA | Systematic Assessment |
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| Pelvic Pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Penile Pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Post Procedural Urine Leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Renal Colic | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Renal Pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Stent Placement | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Thermal Burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Urethral Pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urge Incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary Incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Pain Interference Score Change From Index Procedure to Stent Removal Visit |
|
| Pain Interference Score Change From Index Procedure to Post Stent Removal Visit |
|