InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study (BASIC)
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|ClinicalTrials.gov Identifier: NCT04016324|
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Urinary Urge Incontinence Urgency-frequency Syndrome||Device: InterStim Basic Evaluation lead and foramen needle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim Basic Evaluation Lead.|
|Masking:||None (Open Label)|
|Official Title:||InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study|
|Actual Study Start Date :||November 28, 2019|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.
Device: InterStim Basic Evaluation lead and foramen needle
Commercial devices within their intended use as described in approved Instructions for Use.
- Motor or sensory response(s) during lead placement [ Time Frame: During lead implant ]To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016324
|Contact: Rachael McNamarafirstname.lastname@example.org|
|Study Director:||BASIC Clinical Research Study Team||Medtronic|