Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094536
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2004-10-20
Brief Title:
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption System
Sponsor:
CooperSurgical Inc
Organization:
CooperSurgical Inc
Study Overview
Official Title:
A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option Cryoablation Therapy System for Treatment of Menorrhagia
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Her Option Cryoablation Therapy System is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia excessive menstrual bleeding due to benign causes This is a non-incisional procedure which can be performed in a physicians office with minimal sedation
Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6 minutes with the Cryoprobe repositioned in the contralateral cornu
Since completion of the early studies many physicians have experimented with varying freeze patterns using longer freeze durations andor additional freezes at the fundus and the lower uterine segment The results as reported in the literature indicate that these extended freeze patterns produce significantly better results than the original regimen
Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6 minutes with the Cryoprobe repositioned in the contralateral cornu
Since completion of the early studies many physicians have experimented with varying freeze patterns using longer freeze durations andor additional freezes at the fundus and the lower uterine segment The results as reported in the literature indicate that these extended freeze patterns produce significantly better results than the original regimen
Detailed Description:
American Medical Systems Inc AMS hypothesized that the original treatment pattern used to support a previous FDA approval for the Her Option Cryoablation Therapy System for Treatment of abnormal uterine bleeding was not optimal and that extended freeze regimens will result in improved outcomes for patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None