MenorrhagiaPANELNCT01934244
Post Approval NovaSure Essure Labeling Study
An observational study of Menorrhagia, run by Hologic, Inc. at 14 sites in United States.
Trial summary
This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- NovaSure Endometrial Ablation
- Type of treatment
- Medical device
- How many people
- 318 participants
- Where
- 14 sitesUnited States
- Study dates
- Dec 2013to Jan 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Premenopausal women 18 years of age or older who have abnormal uterine bleeding and are candidates for a NovaSure Endometrial Ablation that have already had an Essure Permanent Birth Control system procedure and an Essure Confirmation Test that has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts.
Who may be able to join
- Subject is 18 years of age or older and premenopausal.
- Subject's gynecological history supports the use of NovaSure endometrial ablation for the treatment of menorrhagia.
- Subject has had an Essure Permanent Birth Control System procedure.
- The Essure Confirmation Test has confirmed both bilateral tubal occlusion and satisfactory placement of the Essure micro-inserts. A written report or ECT radiologic films need to be provided by the physician who performed the ECT. If neither is available, the ECT must be repeated prior to enrollment.
- Subject is able to provide informed consent
Who cannot join
- Subject has known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved (atypical) adenomatous hyperplasia.
- Subject has abnormal/obstructive uterine cavity as confirmed by hysteroscopy or other imaging study (e.g. congenital malformation, large fibroid or large polyp)
- Subject with any anatomic condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium.
- Subject has an active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
- Subject has an intrauterine device (IUD) currently in place.
- Subject has active pelvic inflammatory disease or history of recent pelvic infection.
Show all 13Show fewer
- Subject has undiagnosed vaginal bleeding.
- ECT unable to adequately assess bilateral tubal occlusion and proper micro-insert placement.
- Subject has uterine sound measurement greater than 10 cm.
- Subject with a uterine cavity length less than 4 cm.
- Subject with a uterine cavity width less than 2.5 cm, as determined by the width dial of the disposable NovaSure device following device deployment.
- Subject is unable to comply with the protocol and be available for follow up
- In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Bosque Women's Care
Albuquerque, New Mexico, 87109
Westside Women's Care
Arvada, Colorado, 80005
New Horizon Women's Care
Chandler, Arizona, 85224
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404
Seven Hills Women's Center
Cincinnati, Ohio, 45238
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124
Western DuPage Obstetrics and Gynecology
Downers Grove, Illinois, 60515
Minnesota Gynecology and Surgery
Edina, Minnesota, 55435
Tennessee Women's Care
Nashville, Tennessee, 37203
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604
Physicians Care Clinical Research, LLC
Sarasota, Florida, 34239
Rockwood Clinic, P.S.
Spokane, Washington, 99204
Amy Brenner MD & Associates, LLC
West Chester, Ohio, 45069
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Evaluation of the Safety of NovaSure in the Presence of Essure Following the Essure Confirmation Test (ECT) Post-Approval Study
This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.
Read the detailed description
A prospective, single arm, multi-center, post approval study that is designed to provide additional information on the safety of performing a NovaSure Impedence Controlled Endometrial Ablation System in the presence of Essure Permanent Birth Control System, following the Essure Confirmation Test has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts. The study will be conducted at up to 15 clinical sites and enroll 318 patients. Patients who meet the inclusion and none of the exclusion criteria will have the study explained to them and be invited to participate. Enrolled subjects will have baseline data collected at the time of their NovaSure procedure and will be followed for 1 month after the NovaSure procedure to be assessed for adverse events.
- Conditions
- Menorrhagia
- Being tested
- NovaSure Endometrial Ablation
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaSure Endometrial AblationDevice
The NovaSure Endometrial Ablation device consists of a disposable single-use, conformable bipolar electrode array mounted on an expandable frame that can create a confluent lesion on the entire interior surface area of the uterine cavity. The device is inserted transcervically into the uterine cavity, and the sheath is retracted to allow the bipolar electrode array to be deployed and conform to the uterine cavity. The disposable device works in conjunction with a dedicated NovaSure RF (radio frequency) controller to perform customized, global endometrial ablation.
| Study group | Role | What they receive |
|---|---|---|
| Per Protocol | All enrolled patients in which all inclusion/exclusion criteria were met and the NovaSure endometrial ablation was completed. Receives: Device: NovaSure Endometrial Ablation | |
| Primary | All enrolled patients in whom the Novasure device was inserted. | |
| Intent to treat | All enrolled patients in which NovaSure device was attempted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Essure micro-insert removal with NovaSure device
At the end of the NovaSure treatment and upon removal of the NovaSure device, the device will be directly observed to see if any Essure micro-insert(s) is(are) attached.
Measured: NovaSure procedure visit (Day 1)
Secondary outcomes (1)
Number and percentage of subjects with adverse events
Adverse events reported during and/or immediately post operative the NovaSure procedure.
Adverse events reported up to 1 month after the NovaSure procedure
Measured: NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Evantash, MD, Study director, Hologic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934244
- Sponsor's protocol ID
- S0112003
- Acronym
- PANEL
- Status last verified
- Jul 2018
- First submitted
- 26 Aug 2013
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Basinski CM, Price P, Burkhart J, Johnson J. Safety and Effectiveness of NovaSure(R) Endometrial Ablation After Placement of Essure(R) Micro-Inserts. J Gynecol Surg. 2012 Apr;28(2):83-88. doi: 10.1089/gyn.2011.0061.
PubMed 24761128Saunders, D: Essure and Endometrial Ablation: Clinical studies and case reviews of Essure with 118 NovaSure procedures, Supplement to OBG Management, April, 2010.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of NovaSure in the Presence of Essure Following the Essure Confirmation Test (ECT) Post-Approval Study
- ClinicalTrials.gov ID
- NCT01934244
- Acronym / sponsor ID
- PANEL / S0112003
- Conditions
- Menorrhagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 4 Sep 2013 (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.
This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.
Detailed description
A prospective, single arm, multi-center, post approval study that is designed to provide additional information on the safety of performing a NovaSure Impedence Controlled Endometrial Ablation System in the presence of Essure Permanent Birth Control System, following the Essure Confirmation Test has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts. The study will be conducted at up to 15 clinical sites and enroll 318 patients. Patients who meet the inclusion and none of the exclusion criteria will have the study explained to them and be invited to participate. Enrolled subjects will have baseline data collected at the time of their NovaSure procedure and will be followed for 1 month after the NovaSure procedure to be assessed for adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Per Protocol | – | Device: NovaSure Endometrial AblationAll enrolled patients in which all inclusion/exclusion criteria were met and the NovaSure endometrial ablation was completed. |
| Primary | – | –All enrolled patients in whom the Novasure device was inserted. |
| Intent to treat | – | –All enrolled patients in which NovaSure device was attempted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Premenopausal women 18 years of age or older who have abnormal uterine bleeding and are candidates for a NovaSure Endometrial Ablation that have already had an Essure Permanent Birth Control system procedure and an Essure Confirmation Test that has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts.
Key inclusion criteria (5 listed)
- Subject is 18 years of age or older and premenopausal.
- Subject's gynecological history supports the use of NovaSure endometrial ablation for the treatment of menorrhagia.
- Subject has had an Essure Permanent Birth Control System procedure.
- The Essure Confirmation Test has confirmed both bilateral tubal occlusion and satisfactory placement of the Essure micro-inserts. A written report or ECT radiologic films need to be provided by the physician who performed the ECT. If neither is available, the ECT must be repeated prior to enrollment.
- Subject is able to provide informed consent
Key exclusion criteria (13 listed)
- Subject has known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved (atypical) adenomatous hyperplasia.
- Subject has abnormal/obstructive uterine cavity as confirmed by hysteroscopy or other imaging study (e.g. congenital malformation, large fibroid or large polyp)
- Subject with any anatomic condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium.
- Subject has an active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
- Subject has an intrauterine device (IUD) currently in place.
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 |
|---|---|---|
| NovaSure Endometrial AblationThe NovaSure Endometrial Ablation device consists of a disposable single-use, conformable bipolar electrode array mounted on an expandable frame that can create a confluent lesion on the entire interior surface area of the uterine cavity. The device is inserted transcervically into the uterine cavity, and the sheath is retracted to allow the bipolar electrode array to be deployed and conform to the uterine cavity. The disposable device works in conjunction with a dedicated NovaSure RF (radio frequency) controller to perform customized, global endometrial ablation. | Device | Per Protocol |
Primary outcome
Rate of Essure micro-insert removal with NovaSure device
Time frame: NovaSure procedure visit (Day 1)
At the end of the NovaSure treatment and upon removal of the NovaSure device, the device will be directly observed to see if any Essure micro-insert(s) is(are) attached.
1 secondary outcome
Number and percentage of subjects with adverse events
Time frame: NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Background: PubMed 24761128Basinski CM, Price P, Burkhart J, Johnson J. Safety and Effectiveness of NovaSure(R) Endometrial Ablation After Placement of Essure(R) Micro-Inserts. J Gynecol Surg. 2012 Apr;28(2):83-88. doi: 10.1089/gyn.2011.0061.
- BackgroundSaunders, D: Essure and Endometrial Ablation: Clinical studies and case reviews of Essure with 118 NovaSure procedures, Supplement to OBG Management, April, 2010.
- Hologic, Inc. websiteLink provided by the sponsor.
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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.
Edward Evantash, MD study director
Hologic, Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia, run by Hologic, Inc. at 14 sites 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Results are not available in the source record.
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?
Rate of Essure micro-insert removal with NovaSure device (time frame: NovaSure procedure visit (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01934244, which also lists 2 linked publications.
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 30 Jul 2018.