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|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS130041 / PSS002 |
| Date Original Plan Accepted |
11/21/2013
|
| Date Current Plan Accepted |
12/09/2013
|
| Study Name |
(IDE) Long Term Follow-up
|
| Device Name |
Acessa system
|
| Root Document Number |
K121858
|
| General Study Protocol Parameters |
| Study Design |
Retrospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a post-market, randomized, prospective, multi-center, longitudinal, comparative study to compare the rates of acute and near-term serious complications in the global fibroid ablation (GFA) subjects (groups combined) to the acute and near-term treatment-related serious adverse event rates of the pivotal (pre-market) study. The 522 order questions above are being addressed as endpoints in a larger study being conducted by the sponsor (the Treatment Results of Uterine Sparing Technologies Study, or "TRUST").
|
| Study Population |
Premenopausal female patients greater than or = to 18 years old who have symptomatic fibroids, who desire uterine conservation, and who are indicated for a surgical intervention for their symptoms.
|
| Sample Size |
100 subjects will be enrolled at up to 6 clinical sites within the United States
|
| Key Study Endpoints |
Primary Endpoints: 1.Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near-term treatment-related SAE rates in the pivotal study. Secondary Endpoints: 1. Incidence of serious complications per investigator-surgeon during training and post training. 2. Investigator/surgeon feedback using the Acessa Procedure Evaluation Form.
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| Follow-up Visits and Length of Follow-up |
Subject participation will include evaluations pre-procedure (baseline), immediate post-procedure, and office or phone follow-up visits at 4-8 weeks post treatment. Telephone follow up will occur at 24 to 72 hours post treatment.
|
| Interim or Final Data Summary |
| Final Safety Findings |
The 522 order was fufilled by the IDE final report. The Investigational Device Exemption Reports are considered to be confidential and therefore not releasable.
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