Исследование осуществимости системы окклюзии и реверсирования Plan A
Проспективное, многоцентровое, однорукавное, открытое, интервенционное клиническое исследование, изучающее безопасность и эффективность системы мужской контрацепции Plan A.
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens. 40 men (all sites) will be enrolled and treated with Plan A occlusion (Vasalgel®) using DLAD (Delivery Lumen Access Device). The study will enroll into two groups. Group 1 will include 30 subjects that will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will be offered a vasectomy procedure. Group 2 will recruit ten subjects who will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will have the reversal procedure using the Plan A RD (Reversal Device). This group will be followed for up to another 3 months maximum, or until baseline semen levels are achieved at which point they will be offered a vasectomy procedure. Ten men reaching azoospermia after their occlusion procedure will be allocated to Group 2 and will go on to have the reversal procedure.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Контакты исследования
- Имя: Darlene Walley R Chief Executive Officer, PhD
- Номер телефона: 1-415-407-5229
- Электронная почта: darlene.walley@nextlifesciences.org
Места учебы
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Victoria
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Maribyrnong, Victoria, Австралия, 3032
- Рекрутинг
- Western Urology
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Контакт:
- Homi Zargar, MD
- Номер телефона: +1 61 300 927 427
- Электронная почта: pa@homizargar.com.au
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St Kilda, Victoria, Австралия, 3182
- Рекрутинг
- Dr. Snip
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Контакт:
- Sarah Demediuk, MD
- Номер телефона: 1300 377 647
- Электронная почта: sarah@drsnip.au
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Ontario
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Hawkesbury, Ontario, Канада, K6A 1A8
- Еще не набирают
- Clinique de Vasectomie
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Контакт:
- Jean Philippe-Bercier, MD
- Номер телефона: 613-762-0997
- Электронная почта: jeanphilippebercier@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception
- Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study prior to initiation of any screening or study specific procedures
- 25 to 65 years of age at the time of consent
- Body Mass Index (BMI) <31 kg/m2
- Good health for undergoing a vasectomy as confirmed by medical history, physical examination and clinical laboratory tests of blood and urine at the time of screening
- Normal semen analysis defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
- In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a form of long-term contraception
- Agreement to use an effective method of contraception during the entire clinical trial until the planned vasectomy
- Lives in close proximity to the trial site to enable provision of fresh semen samples unless the subject agrees to provide semen samples at the trial site or laboratory
Exclusion Criteria:
- (On exam, has any of the following); one or both vasa not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study.
- Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy (vasectomy reversal)
- Recurrent pain with ejaculations
- Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices
- Has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution of an acute infection
- History of prostatitis or benign prostatic hypertrophy requiring treatment
- Has undergone prior chemotherapy
- Has known current coagulopathy or other bleeding disorders
- Currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy, alpha blocker)
- Subjects with cystic fibrosis
- Subjects with a history of inguinal hernia repair
- Vulnerable subjects (e.g., subjects with cognitive challenges, incarcerated, etc.)
- Currently participating in another study involving an investigational device or drug (or has participated in a study within the last 30 days prior to screening).
- Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
- In the opinion of the Investigator, there are issues or concerns that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
- Has any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Group 1: Occlusion Procedure
This will be Group 1. Group1 will have the occlusion procedure but will not have the reversal procedure. |
The occlusion system comprised of the Delivery Lumen Access Device and Vasalgel. |
|
Экспериментальный: Group 2: Reversal Procedure
This will be Group 2. Group 2 will have both the occlusion and reversal procedure. |
The occlusion system comprised of the Delivery Lumen Access Device and Vasalgel. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Study subjects achieving azoospermia
Временное ограничение: Starting at the 30 day follow-up visit
|
Total number of subjects (N=40) achieving azoospermia |
Starting at the 30 day follow-up visit
|
|
Study subjects that return to baseline semen levels
Временное ограничение: Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
|
Total number of subjects (N=10) that return to baseline semen levels after reversal |
Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
|
|
Adverse Events
Временное ограничение: From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
|
Rate and severity of adverse events. |
From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
|
|
Subject Comfort
Временное ограничение: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
|
Subject Comfort Assessment Scale Post Occlusion and Reversal |
From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
|
|
Histology
Временное ограничение: From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
|
Excised portion of the vas deferens will be prepared with formalin for histological evaluation |
From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Subject Satisfaction/Comfort Assessment
Временное ограничение: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
|
Patient satisfaction questions along with NRS pain scale are being utilized to determine the comfort of the patient |
From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Homi Zargar, MD, Western Urology
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- CIP102
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .