Reproductive Sterilization
Conditions
Keywords
Female, Sterilization
Brief 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.
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.
Interventions
DEVICEAdiana Transcervical Sterilization System
Implantation of silicone matrix in fallopian tubes
Sponsors
QST Consultations, Ltd.
Hologic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* • 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 * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 Year Pregnancy Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Placement Procedure | 48 hours | Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied. |
| Patient Satisfaction With Device Wearing | Waiting Period (1-Month, 2-Months, 3-Months) | Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied. |
| Device Placement Rate | After First Treatment Attempt | Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement. |
| Patient Comfort With Device Wearing | Waiting Period (1-Month, 2-Months, 3-Months) | Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort. |
| 3 Year Pregnancy Rate | 3 years | 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. |
| Patient Comfort With Placement Procedure | Post-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. |
Countries
Australia, Mexico, United States
Participant flow
Recruitment details
Subjects were enrolled in the trial from 16 investigative sites between November 13, 2002 and April 28, 2005. Fourteen sites were located in the US and two were international sites.
Pre-assignment details
770 subjects were enrolled: 75 withdrew consent and 50 were excluded for pathology/procedural criteria. All subjects were enrolled on an intent to treat (ITT) basis. The ITT population included all patients who were enrolled in the study and had device placement attempted. 645 subjects had treatment attempted. No comparative assessment was made.
Participants by arm
| Arm | Count |
|---|---|
| Adiana Permanent Contraception System Implantation of silicone matrix in fallopian tubes | 645 |
| Total | 645 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 1 Year Wearing Period | Discontinued reilance | 3 |
| 1 Year Wearing Period | Lost to Follow-up | 11 |
| 1 Year Wearing Period | Terminated for protocol non-compliance | 1 |
| 1 Year Wearing Period | Withdrawal by Subject | 2 |
| Waiting Period | Alternative contraception failure | 3 |
| Waiting Period | Bilateral placement failure | 34 |
| Waiting Period | Deemed patent following HSG | 26 |
| Waiting Period | Elected surgical tubal ligation | 5 |
| Waiting Period | Lost to Follow-up | 6 |
| Waiting Period | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Adiana Permanent Contraception System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 645 Participants |
| Age, Continuous All Participants | 31.5 years |
| Sex: Female, Male Female | 645 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 642 / 645 |
| serious Total, serious adverse events | 60 / 645 |
Outcome results
Primary
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.
Time frame: 1 year
Population: 645 participants had treatment attempted; Intent to Treat population. Of these 645, 570 were able to rely on the device and are used to evaluate the pregnancy prevention rate for the 1-year endpoint. During the 1-year follow-up period, there were 6 pregnancies, of which 3 were attributable to physician error, i.e., misinterpretation of HSG results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | 1 Year Pregnancy Rate | 1.1 percentage of participants |
Comparison: 1-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).95% CI: [97.9, 100]
Comparison: 2-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).95% CI: [97.6, 99.5]
Secondary
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.
Time frame: 3 years
Population: Population includes all participants able to rely on Adiana (n=570). This analysis is cumulative and based on survival analysis methodology. Thus, participants only followed for 2 years, for example, would still be included in this cumulative analysis. In total, 481 participants were available with 3 years of follow-up at the time of analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | 3 Year Pregnancy Rate | 1.6 percentage of participants |
Comparison: 1-sided Confidence Interval.~No hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).95% CI: [97.2, 100]
Comparison: 2-sided Confidence Interval~No hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).95% CI: [96.9, 99.1]
Secondary
Device Placement Rate
Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.
Time frame: Including Second Treatment Attempt
Population: Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 611/645 participants after 7 participants underwent a successful second attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | Device Placement Rate | 94.7 percentage of participants |
Secondary
Device Placement Rate
Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.
Time frame: After First Treatment Attempt
Population: Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 604/645 participants after the first procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | Device Placement Rate | 93.6 percentage of participants |
Secondary
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.
Time frame: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
Population: Per protocol population; no imputations for missing data. Minimum comfort reported at 12-Months as 530/532 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | Patient Comfort With Device Wearing | 99.6 percentage of participants |
Secondary
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.
Time frame: Waiting Period (1-Month, 2-Months, 3-Months)
Population: Intent to treat population; no imputations for missing data. Minimum comfort reported at 1-Month as 604/608 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | Patient Comfort With Device Wearing | 99.3 percentage of participants |
Secondary
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.
Time frame: 48 hours
Population: Intent to treat population; no imputations for missing data. Minimum comfort reported as 578/632 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | Patient Comfort With Placement Procedure | 91.5 percentage of participants |
Secondary
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.
Time frame: Post-Procedure
Population: Intent to treat population; no imputations for missing data. Minimum comfort reported as 504/629 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | Patient Comfort With Placement Procedure | 80.1 percentage of participants |
Secondary
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.
Time frame: Waiting Period (1-Month, 2-Months, 3-Months)
Population: Intent to treat population; no imputations for missing data. Minimum satisfaction reported at 2-Months as 587/613 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | Patient Satisfaction With Device Wearing | 95.8 percentage of participants |
Secondary
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.
Time frame: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
Population: Per protocol population; no imputations for missing data. Minimum satisfaction reported at 12-Months as 528/531 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | Patient Satisfaction With Device Wearing | 99.4 percentage of participants |
Secondary
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.
Time frame: 48 hours
Population: Intent to treat population; no imputations for missing data. Minimum satisfaction reported as 605/625 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adiana Permanent Contraception System | Patient Satisfaction With Placement Procedure | 96.8 percentage of participants |