A Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method
SAFE: Surveillance And Follow-up Evaluation of FemBloc
A Prospective Observational Pilot Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method in Spain
研究概览
详细说明
A Prospective Observational Pilot Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method in Spain
研究类型
注册 (估计的)
联系人和位置
学习地点
-
-
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Badajoz、西班牙
- Hospital Materno Infantil de Badajoz
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Barakaldo、西班牙
- Hospital Universitario de Cruces
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Bilbao、西班牙
- Hospital Universitario Basurto
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Burgos、西班牙
- Hospital Universitario de Burgos
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Córdoba、西班牙
- Hospital Universitario Reina Sofía
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Granada、西班牙
- Hospital Universitario Virgen de las Nieves
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Las Palmas de Gran Canaria、西班牙
- Hospital Universitario Materno Infantil de Canarias
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Lleida、西班牙
- Hospital Arnau de Vilanova
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Madrid、西班牙
- Hospital Universitario La Paz
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Majadahonda、西班牙
- Hospital Universitario Puerta De Hierro
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Móstoles、西班牙
- Hospital Universitario de Móstoles
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Salamanca、西班牙
- Hospital Clínico Universitario de Salamanca
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San Sebastián、西班牙
- Hospital Universitario Donostia
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San Sebastián de los Reyes、西班牙
- Hospital Universitario Infanta Sofía
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Santander、西班牙
- Hospital Universitario Marqués de Valdecilla
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Seville、西班牙
- Hospital Universitario Virgen Macarena
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Seville、西班牙
- Hospital Universitario Virgen del Rocío
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Valencia、西班牙
- Hospital Universitario y Politécnico La Fe
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Zaragoza、西班牙
- Hospital Lozano Blesa
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La Rioja
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Logroño、La Rioja、西班牙
- Hospital Universitario San Pedro
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Females of child-bearing age who desire permanent birth control
描述
Inclusion Criteria:
- Women between 21 and 49 years old with a desire for permanent contraception
- No desire for future motherhood
- Capacity to give informed consent
- Candidates for the FemBloc procedure according to medical assessment
- Willing to continue using their alternative method of contraception until confirmation of occlusion
- Women who have had the FemBloc procedure performed by clinical practice as of August 1, 2025, that meet all other inclusion and none of the exclusion criteria, and that have medical records collected with the necessary information for the study in order to comply with it
Exclusion Criteria:
- Previous tubal surgery
- Ectopic pregnancy
- Uterine malformations or difficulties in cervical canalization
- Active or recent genital infection
- Known hypersensitivity to the polymer or formaldehyde
- Postpartum or abortion within the last 6 weeks
- Undiagnosed abnormal uterine bleeding
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
FemBloc
Device |
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Degree of patient satisfaction
大体时间：At time of procedure
|
To evaluate the acceptance of the FemBloc procedure in real life by female candidates by measuring the degree of satisfaction reported by participants on Likert scale (1-5, 5=highest satisfaction) |
At time of procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of device- and/or procedure-related safety events
大体时间：At the time of procedure and up through 3 months post procedure
|
Number of participants with device- and/or procedure-related adverse events |
At the time of procedure and up through 3 months post procedure
|
|
Pain
大体时间：At the time of procedure
|
Measure the degree of pain reported by participants on Visual Analog Scale (0-10 scale, 10 = intense pain) |
At the time of procedure
|
|
Bilateral occlusion rate
大体时间：3 months post procedure
|
Rate of bilateral tubal occlusion using saline-air contrast ultrasound |
3 months post procedure
|
|
Pregnancy rate
大体时间：12 months post procedure and confirmation test
|
Rate of pregnancies among the participants |
12 months post procedure and confirmation test
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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