Analysis of the safety and reliability of a hydrothermal ablation system: a multicenter, prospective postmarket study.

Publication/Presentation Date

1-1-2014

Abstract

OBJECTIVE: To obtain information on practitioner experience in the use of the Genesys HydroThermAblator (HTA) System under normal clinical conditions through documentation of the system's acute safety features, in terms of burn rates, and its technical reliability.

STUDY DESIGN: This was a prospective, observational, multicenter, postmarket interventional clinical trial with outcome measures of acute (within 21 days post-procedure) safety, serious adverse device effects, and technical malfunctions in a population of premenopausal women > or = 18 years of age.

RESULTS: A total of 992 women (mean age, 41.7 +/- 6.8 years; range, 22-65 years) were enrolled in 18 clinical sites throughout the United States. The Genesys HTA System provided low burn rates in the intent-to-treat (n = 992 [0.4%] [95% CI 0.1-1.0%]) and evaluable (n = 931 [0.2%] [95% CI 0.1-0.8%]) subject populations. Only 1 burn was clinically significant and was defined as a serious adverse device effect (1/992 [0.10%] [95% CI 0.0-0.6%]). Fifty-three (5.1%) technical malfunctions occurred in 44 procedures, and 27 (27/44 [61.4%]) patients completed their procedures after 31 (31/ 53 [58.5%]) technical problems were addressed and resolved.

CONCLUSION: The Genesys HTA System delivers a safe and reliable treatment option for premenopausal women with heavy menstrual bleeding.

Volume

59

Issue

5-6

First Page

299

Last Page

305

ISSN

0024-7758

Disciplines

Medicine and Health Sciences

PubMedID

24937973

Department(s)

Department of Obstetrics and Gynecology

Document Type

Article

Link to Full Text

Share

COinS