check_circleStudy Completed
Hysterectomy
Bayer Identifier:
18473
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Proportion of hysterectomy after female sterilization
Trial purpose
The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had undergone sterilization through tubal ligation.
Key Participants Requirements
Sex
FemaleAge
18 - 49 YearsTrial summary
Enrollment Goal
10578Trial Dates
August 2015 - December 2015Phase
N/ACould I Receive a placebo
NoProducts
Essure (ESS305, BAY1454032)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | New Jersey, United States |
Primary Outcome
- Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placementThe study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH)date_rangeTime Frame:Retrospective analysis of 10 year periodenhanced_encryptionNoSafety Issue:
- Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligationThe study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH)date_rangeTime Frame:Retrospective analysis of 10 year periodenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DeviceTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A