HysterectomyNCT02532361
Proportion of Hysterectomy After Female Sterilization
An observational study of Hysterectomy, run by Bayer at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Hysteroscopic device placement including Essure (ESS305, BAY1454032) and Tubal ligation
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 10,578 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 18 - 49 at index date who underwent hysteroscopic device sterilization procedure or tubal ligation sterilization procedure. Index date: Date of sterilization procedure
Who may be able to join
- 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
Who cannot join
- Patients undergoing in-vitro fertilization (IVF) procedures
- Embryo transfer, intrauterine
- Follicle puncture for oocyte retrieval, any method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Hysterectomy
- Being tested
- Hysteroscopic device placement including Essure (ESS305, BAY1454032), Tubal ligation
- Keywords
- Sterilization, Hysteroscopic Device Placement, Tubal Ligation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic device placement including Essure (ESS305, BAY1454032)Device
Essure is a permanent, minimally invasive, non-hormonal implantable device used for contraception and Adiana sterilization method is a combination of controlled thermal damage to the lining of the fallopian tube followed by insertion of a non-absorbable biocompatible silicone elastomer matrix within the tubal lumen
Tubal ligationProcedure or surgery
Tubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for implantation
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 / Hysteroscopic device placement | Patients that had undergone sterilization through hysteroscopic device placement Receives: Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032) | |
| Cohort 2 / Tubal ligation | Patients that had undergone sterilization through tubal ligation Receives: Procedure: Tubal ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Retrospective analysis of 10 year period
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)
Measured: Retrospective analysis of 10 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532361
- Sponsor's protocol ID
- 18473
- Status last verified
- Dec 2016
- First submitted
- 21 Aug 2015
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02532361
- Acronym / sponsor ID
- 18473
- Conditions
- Hysterectomy
- Keywords
- Sterilization, Hysteroscopic Device Placement, Tubal Ligation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,578 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 / Hysteroscopic device placement | – | Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032)Patients that had undergone sterilization through hysteroscopic device placement |
| Cohort 2 / Tubal ligation | – | Procedure: Tubal ligationPatients that had undergone sterilization through tubal ligation |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18 - 49 at index date who underwent hysteroscopic device sterilization procedure or tubal ligation sterilization procedure. Index date: Date of sterilization procedure
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients undergoing in-vitro fertilization (IVF) procedures
- Embryo transfer, intrauterine
- Follicle puncture for oocyte retrieval, any method
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopic device placement including Essure (ESS305, BAY1454032)Essure is a permanent, minimally invasive, non-hormonal implantable device used for contraception and Adiana sterilization method is a combination of controlled thermal damage to the lining of the fallopian tube followed by insertion of a non-absorbable biocompatible silicone elastomer matrix within the tubal lumen | Device | Cohort 1 / Hysteroscopic device placement |
| Tubal ligationTubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for implantation | Procedure or surgery | Cohort 2 / Tubal ligation |
Primary outcome
Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement
Time frame: Retrospective analysis of 10 year period
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)
Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation
Time frame: Retrospective analysis of 10 year period
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement (time frame: Retrospective analysis of 10 year period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.