check_circleStudy Completed

Hysterectomy

Bayer Identifier:

18473

ClinicalTrials.gov Identifier:

NCT02532361

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

Female

Age

18 - 49 Years
  • - Age: 18 to 49 years at index date
    - Gender: Female
    - Diagnosis: Women who underwent hysteroscopic device sterilization procedure
    - Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy


  • - Patients undergoing in-vitro fertilization (IVF) procedures
    - Embryo transfer, intrauterine
    - Follicle puncture for oocyte retrieval, any method

Trial summary

Enrollment Goal
10578
Trial Dates
August 2015 - December 2015
Phase
N/A
Could I Receive a placebo
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
New Jersey, United States

Primary Outcome

  • Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement
    The 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 period
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation
    The 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 period
    enhanced_encryption
    Safety Issue:
    No

Trial design

A retrospective analysis to describe the proportion of hysterectomy after female sterilization with hysteroscopic device or tubal ligation using Intermountain Healthcare database in the US
Trial Type
Observational
Intervention Type
Device
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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