MenorrhagiaPhase 4NCT00094536
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
A Phase 4 study testing Extended treatment regimen using Her Option Cryotherapy in people with Menorrhagia, run by CooperSurgical Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 100 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Extended treatment regimen using Her Option Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2004to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-menopausal adult women 30 years of age or older who have completed childbearing
- Heavy or prolonged menstrual bleeding
- Willing and able to complete all follow-up exams as required by protocol
Who cannot join
- Known or suspected endometrial cancer or pre-malignant change of the endometrium
- Untreated cervical dysplasia
- Hereditary malformations of the uterine cavity that would prevent insertion and/or placement of the cryoprobe
- Uterine myomas > or = to 3 cm in diameter
- Past history of invasive treatment for abnormal uterine bleeding or uterine myomas
- History of classical (not low transverse incision) cesarean section
Show all 9Show fewer
- Active genital or urinary tract infection or acute pelvic inflammatory disease (PID)
- Intrauterine device (IUD) in place
- Other medical conditions could be exclusionary upon evaluation for study treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lahey Clinic
Burlington, Massachusetts, 01805
Jose Manjon, M.D. (Private practice)
Camp Hill, Pennsylvania, 17011
Center for Endometrial Ablation
Charlotte, North Carolina, 28262
Duke University Medical Center
Durham, North Carolina, 27710
Kelly Roy, M.D., P.C.
Phoenix, Arizona, 85013
Valley OB/GYN
Saginaw, Michigan, 48602
Institute for Women's Health & Body
Wellington, Florida, 33414
About this study
Official title: A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option® Cryoablation Therapy System for Treatment of Menorrhagia
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 and/or 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.
Read the 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.
- Conditions
- Menorrhagia
- Being tested
- Extended treatment regimen using Her Option Cryotherapy
- Keywords
- Menorrhagia, Excessive Uterine Bleeding, Cryoablation, Menstrual disorder, Endometrial ablation, Abnormal uterine bleeding, Dysfunctional uterine bleeding
- Medical subject headings
- Menorrhagia, Menstruation Disturbances, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended treatment regimen using Her Option CryotherapyDevice
Also called Her Option
Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.
| Study group | Role | What they receive |
|---|---|---|
| Extended Treatment Regimen | Experimental | Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less. Receives: Device: Extended treatment regimen using Her Option Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success (Reduction in Menstruation to Normal Levels)
Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2004 (estimated)
- Study startApr 2004
- Primary completionOct 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperSurgical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094536
- Sponsor's protocol ID
- AMS043
- Status last verified
- Mar 2017
- First submitted
- 20 Oct 2004
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option® Cryoablation Therapy System for Treatment of Menorrhagia
- ClinicalTrials.gov ID
- NCT00094536
- Acronym / sponsor ID
- AMS043
- Conditions
- Menorrhagia
- Keywords
- Menorrhagia, Excessive Uterine Bleeding, Cryoablation, Menstrual disorder, Endometrial ablation, Abnormal uterine bleeding, Dysfunctional uterine bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- CooperSurgical Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Oct 2004 (estimated)
- Results
- Posted 3 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and/or 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended Treatment Regimen | Experimental | Device: Extended treatment regimen using Her Option CryotherapyExtended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pre-menopausal adult women 30 years of age or older who have completed childbearing
- Heavy or prolonged menstrual bleeding
- Willing and able to complete all follow-up exams as required by protocol
Key exclusion criteria (9 listed)
- Known or suspected endometrial cancer or pre-malignant change of the endometrium
- Untreated cervical dysplasia
- Hereditary malformations of the uterine cavity that would prevent insertion and/or placement of the cryoprobe
- Uterine myomas > or = to 3 cm in diameter
- Past history of invasive treatment for abnormal uterine bleeding or uterine myomas
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 |
|---|---|---|
| Extended treatment regimen using Her Option CryotherapyAlso: Her OptionExtended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less. | Device | Extended Treatment Regimen |
Primary outcome
Success (Reduction in Menstruation to Normal Levels)
Time frame: 1 Year
Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extended treatment regimen using Her Option Cryotherapy in people with Menorrhagia, run by CooperSurgical Inc. at 7 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 3 inclusion and 9 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Success (Reduction in Menstruation to Normal Levels) (time frame: 1 Year). 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 3 Mar 2017.