Reproductive SterilizationEASENCT00737061
Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)
A study testing Adiana Transcervical Sterilization System in people with Reproductive Sterilization, run by Hologic, Inc. at 16 sites in 3 countries.
Trial summary
The purpose of this study is to demonstrate the safety \& efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Sterilization
- What is being tested?
- Adiana Transcervical Sterilization System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Nov 2002to 4 Feb 2013
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Women aged 18 to 45
- Women who are seeking permanent contraception
- Women who are at risk of becoming pregnant
- Willing to risk becoming pregnant when relying on the Adiana device for contraception
- Relatively normal uterine cavity, uterine wall thickness, and uterine size as demonstrated by pelvic sonography
- Willing to keep a coital/menstrual log
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- Have at least one confirmed pregnancy and one living child
- Monogamous relationship with a partner who has proven fertility
- Sexually active (at least 4 acts of intercourse per month)
- Willing to use alternate contraception (either a barrier method or oral contraceptive pills or other monthly, cyclic, hormonal birth control) during the three months following device placement prior to relying on the Adiana device for contraception
- Willing and able to maintain in regular contact with the investigator
- Women with regular, cyclical menses within 2 months prior to the device placement procedure
- Able to provide informed consent
Who cannot join
- Women who are unsure of their desire to end their fertility
- Presence of gross genital infection, including sepsis
- Presence of chlamydia, gonorrhea or syphilis
- Presence of genital cancer (note: CIN1 is acceptable)
- Intra-uterine pathology which would prevent optimal access to the tubal ostium and intramural portion of the fallopian tube, such as large submucous fibroids or uterine adhesions
- History of chronic pelvic pain (present within the previous year), prior ectopic pregnancy, or fallopian tube surgery, or currently diagnosed severe dysmenorrhea, severe dyspareunia, endometriosis, adenomyosis, or pelvic inflammatory disease
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- Women with unresolved tubal, ovarian or endometrial pathology
- Uterine neoplasia or precursors to neoplasia
- Dysfunctional uterine bleeding or intermenstrual bleeding within the prior three months
- Women who have not had at least two normal periods after the following events: irregular periods treated with oral contraceptives (or other monthly, cyclic, hormonal birth control) which have since been discontinued, IUD removal, childbirth, or termination of pregnancy
- Currently taking immunosuppressive medications including steroids
- Pregnancy
- Uterine perforation within the last 3 months
- Contraindications for surgical methods of sterilization
- Less than three months have passed since the last delivery or abortion
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States14 sites
St. Luke's Hospital
Chesterfield, Missouri, 63017
Duke Fertility Center
Durham, North Carolina, 27713
Minnesota Gynecology and Surgery
Edina, Minnesota, 55435
Baylor Research Institute
Fort Worth, Texas, 76104
Reproductive Specialty Center
Milwaukee, Wisconsin, 53211
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Center for Fertility and Women's Health
New Britain, Connecticut, 06050
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Women's Health Research
Phoenix, Arizona, 85015
Kaiser Permanente
Roseville, California, 95661
Kaiser Permanente
San Rafael, California, 94903
Reproductive Science Center
San Ramon, California, 94583
Institute for Women's Health and Body
Wellington, Florida, 33414
Center for Reproductive Medicine
Wichita, Kansas, 67226
About this study
Official title: A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial
The purpose of this study is to demonstrate the safety \& efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
Read the detailed description
Participants who demonstrated to be bilaterally occluded by hysterosalpingogram (HSG) evaluations are allowed to rely on the Adiana System for pregnancy prevention and enter the Wearing Period of follow-up.
Secondary endpoints inlcude safety of device placement procedure and safety of device wearing. The adverse events recorded during the course of the study are entered under adverse events.
- Conditions
- Reproductive Sterilization
- Being tested
- Adiana Transcervical Sterilization System
- Keywords
- Female, Sterilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adiana Transcervical Sterilization SystemDevice
Implantation of silicone matrix in fallopian tubes
| Study group | Role | What they receive |
|---|---|---|
| Adiana Transcervical Sterilization System | Experimental | Single arm treatment Receives: Device: Adiana Transcervical Sterilization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 Year Pregnancy Rate
Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.
Measured: 1 year
Secondary outcomes (10)
Device Placement Rate
Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.
Measured: After First Treatment Attempt
Device Placement Rate
Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.
Measured: Including Second Treatment Attempt
Patient Satisfaction With Placement Procedure
Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.
Measured: 48 hours
Patient Satisfaction With Device Wearing
Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.
Measured: Waiting Period (1-Month, 2-Months, 3-Months)
Patient Satisfaction With Device Wearing
Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.
Measured: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
Patient Comfort With Placement Procedure
Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.
Measured: Post-Procedure
Patient Comfort With Placement Procedure
Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.
Measured: 48 hours
Patient Comfort With Device Wearing
Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.
Measured: Waiting Period (1-Month, 2-Months, 3-Months)
Patient Comfort With Device Wearing
Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.
Measured: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
3 Year Pregnancy Rate
Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startNov 2002
- Primary completionDec 2005
- Study completion4 Feb 2013
Why it stopped: Product Pre-Market Approval withdrawn
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 Reproductive SterilizationStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QST Consultations, Ltd.
- Responsible party
- Sponsor
- Investigators
- Edward Evantash, MD, Study director, Hologic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737061
- Sponsor's protocol ID
- P0071
- Acronym
- EASE
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2008
- Last updated
- 8 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial
- ClinicalTrials.gov ID
- NCT00737061
- Acronym / sponsor ID
- EASE / P0071
- Conditions
- Reproductive Sterilization
- Keywords
- Female, Sterilization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product Pre-Market Approval withdrawn
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Collaborators
- QST Consultations, Ltd.
- Study start
- Nov 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- 4 Feb 2013 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Posted 25 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the safety \& efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
Detailed description
Participants who demonstrated to be bilaterally occluded by hysterosalpingogram (HSG) evaluations are allowed to rely on the Adiana System for pregnancy prevention and enter the Wearing Period of follow-up.
Secondary endpoints inlcude safety of device placement procedure and safety of device wearing. The adverse events recorded during the course of the study are entered under adverse events.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adiana Transcervical Sterilization System | Experimental | Device: Adiana Transcervical Sterilization SystemSingle arm treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- • Women aged 18 to 45
Key exclusion criteria (15 listed)
- Women who are unsure of their desire to end their fertility
- Presence of gross genital infection, including sepsis
- Presence of chlamydia, gonorrhea or syphilis
- Presence of genital cancer (note: CIN1 is acceptable)
- Intra-uterine pathology which would prevent optimal access to the tubal ostium and intramural portion of the fallopian tube, such as large submucous fibroids or uterine adhesions
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 |
|---|---|---|
| Adiana Transcervical Sterilization SystemImplantation of silicone matrix in fallopian tubes | Device | Adiana Transcervical Sterilization System |
Primary outcome
1 Year Pregnancy Rate
Time frame: 1 year
Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.
10 secondary outcomes
Device Placement Rate
Time frame: After First Treatment Attempt
Device Placement Rate
Time frame: Including Second Treatment Attempt
Patient Satisfaction With Placement Procedure
Time frame: 48 hours
Patient Satisfaction With Device Wearing
Time frame: Waiting Period (1-Month, 2-Months, 3-Months)
Patient Satisfaction With Device Wearing
Time frame: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
Patient Comfort With Placement Procedure
Time frame: Post-Procedure
Patient Comfort With Placement Procedure
Time frame: 48 hours
Patient Comfort With Device Wearing
Time frame: Waiting Period (1-Month, 2-Months, 3-Months)
Patient Comfort With Device Wearing
Time frame: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
3 Year Pregnancy Rate
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adiana Transcervical Sterilization System in people with Reproductive Sterilization, run by Hologic, Inc. at 16 sites in 3 countries.
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 13 inclusion and 15 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: stopped early, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia, Mexico. 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?
Yes. Results are posted in the registry (first posted 25 Jan 2013). 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?
1 Year Pregnancy Rate (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 8 Sep 2017.