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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS130041 / PSS001 |
| Date Original Plan Accepted |
02/28/2014
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| Date Current Plan Accepted |
05/27/2016
|
| Study Name |
Newly Enrolled
|
| Device Name |
Acessa system
|
| Root Document Number |
K121858
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a post-market, 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 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 = 18 years old who have symptomatic fibroids, who desire uterine
conservation, and who are indicated for a surgical intervention for their symptoms.
Inclusion Criteria: Women who:
1. Are = 18 years old and menstruating
2. Have symptomatic uterine fibroids
3. Have a uterine size =16 gestational weeks as determined by pelvic exam
4. Have all fibroids that are less than 10 cm in any diameter
5. Desire uterine conservation
6. Have had a normal Pap smear within the past 36 months defined as “no untreated cervical malignancy or dysplasia.”
7. Are willing and able to comply with all study tests, procedures, and assessment tools
8. Are capable of providing informed consent.
Exclusion Criteria:
Women who:
1. Have contraindications for laparoscopic surgery and/or general anesthesia.
2. Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
3. Patients requiring major elective concomitant procedures (e.g., hernia repair)
4. Are pregnant or lactating
5. Have taken any depot GnRh agonist within three months prior to the screening procedures
6. Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least 10 days prior to treatment
7. Have chronic pelvic pain known to not be due to uterine fibroids
8. Have known or suspected endometriosis Stage 3 or 4, or adenomyosis
9. Have active or history of pelvic inflammatory disease
10. Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years
11. Have had pelvic radiation
12. Have a non-uterine pelvic mass over 3 cm
13. Have a cervical myoma
14. Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1
submucous fibroids that are better treated via hysteroscopic methods
15. In the medical judgment of the investigator should not participate in the study
16. Are not willing to be randomized to treatment.
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| Sample Size |
100 subjects will be enrolled at up to 6 clinical sites within the United States.
|
| Key Study Endpoints |
The 522 order questions are being addressed as endpoints in a larger study being conducted by the sponsor (the Treatment Results of Uterine Sparing Technologies Study, or “TRUST”).
Primary Endpoints:
• 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:
• Incidence of serious complications per investigator-surgeon during training and post training.
• 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 |
| Actual Number of Patients Enrolled |
14 study sites were enrolled in the U.S. and Canada.
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| Actual Number of Sites Enrolled |
105 subjects were enrolled and treated.
|
| Patient Followup Rate |
104/105 (99.0%) subjects completed 30-day follow-up.
|
| Final Safety Findings |
Primary endpoint #1: Acute serious complications (within 48 hrs of treatment). There were no acute serious complications, for a rate of 0%, less than the rate in the premarket study (1.76%). Primary endpoint #2: Near-term serious complications (within 2-30 days of treatment). There was one near-term serious complication (fever of unknown origin requiring hospitalization), for a rate of 0.96% (95% confidence interval: 0.02%, 5.19%), which was not statistically higher than the rate in the premarket study (0.73%).
Regarding surgeon feedback, 0/26 surgeons reported problems experienced with the Acessa procedure; 0/26 reported problems with overall ease of use; 2/26 reported that the ability to view the probe and electrode tips on laparoscopic ultrasound needed improvement; and 13/26 surgeons provided suggestions for improving the procedure.
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| Study Strengths and Weaknesses |
The study strengths included high rate of follow-up, and the inclusion of newly trained physicians as well as physicians experienced with the device. A weakness of this study is the small number of ethnic minority subjects, particularly Hispanic/Latin American women.
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| Recommendations for Labeling Changes |
As recommended in the FDA’s decision letter dated May 25, 2018, the sponsor submitted updated labeling to include the results of the 522 study. Therefore, the final study status can be considered completed.
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