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NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric |
| ||
| Male Adult Obstructive | |||
| Male Adult Incontinence and/or Overactive Bladder |
| ||
| Female Adult Obstructive | |||
| Female Adult Incontinence and/or Overactive Bladder |
| ||
| Adults with Neurological Co-morbidities |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urodynamic procedure | Diagnostic Test | Urodynamic procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess NXT system performance | Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient? | 120 Minutes |
| Assess NXT system safety | The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events. | 120 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Assess NXT system performance | Assess the proportion of affirmative responses to the question: Was the urodynamic study completed without any technical failure that prevented its completion? | 120 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Male, Female and Pediatric subjects who have been medically indicated for UDS testing.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaitlyn Palm | Contact | 6128160068 | rs.nxtpmcf@laborie.com | |
| Adele Campbell | Contact | 6032558251 | rs.nxtpmcf@laborie.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chesapeake Urology Hanover | Recruiting | Hanover | Maryland | 21076 | United States |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| D001750 | Urinary Bladder, Neurogenic |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Chesapeake Urology Owing Mills | Recruiting | Owing Mills | Maryland | 21117 | United States |
|
| Nationwide Children's Hospital | Not yet recruiting | Columbus | Ohio | 43205 | United States |
|
| Ohio State University | Recruiting | Columbus | Ohio | 43212 | United States |
|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |