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The purpose of this pivotal study is to demonstrate safety and effectiveness of the CompuFlo® Epidural Computer Controlled System (referred to hereafter as CompuFlo® Epidural) for the epidural space verification.
The CompuFlo® Epidural System is limited by federal law for investigational use only in United States of America and has received CE mark in European Union.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Standard Care Group (SCG) | Active Comparator | Standard Care Conventional Group (SCG): 158 subjects to receive lumbar epidural procedure with the loss of resistance syringe used to identify the epidural space |
|
| Experimental Procedure Group (EPG). | Experimental | 158 of subjects to receive lumbar epidural procedure with the CompuFlo® Epidural System used to identify the epidural space |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active: Comparator Loss Of Resistance Syringe | Device | Lumbar epidural procedure utilizing Loss of Resistance Syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Objective (successful performance of lumbar epidural procedure) | Primary study endpoint is successful performance of lumbar epidural procedure indicated by loss to temperature sensation bilateral either 1) (i) in at least one dermatome for the non-labor procedures procedures or (ii) in at least two dermatomes for women in labor two dermatomes*, based on a maximum of 3 attempts at epidural space identificationor 2) by correct spread of dye in the epidural space as observed by fluoroscopy for those patients for whom fluoroscopy is performed as a standard medical procedure to identify the exact spine level (landmarking) along with confirmatory contrast dye, based on a maximum of 3 attempts at epidural space identification This is a binary categorical (yes/no) endpoint. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Gebhard, MD | Professor of Anesthesiology Professor of Orthopedics and Rehabilitation Director, Division of Regional Anesthesia and Acute Perioperative Pain Management University of Miami-Miller School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92697 | United States | ||
| Vitamed Research |
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| Experimental: CompuFlo® Epidural System | Device | CompuFlo® Epidural is intended for use with an epidural needle for the verification of needle tip placement in the lumbar epidural space |
|
| Rancho Mirage |
| California |
| 92270 |
| United States |
| San Diego Pain Institute | San Diego | California | 92111 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| University of Texas Houston | Houston | Texas | 77030 | United States |