Histological Evaluation of Dual-wavelength Diode Laser Ablation of Ovarian Endometrioma (DUALENDO)
Histological Evaluation of Ovarian Endometrioma Ablation Using a Dual-wavelength Diode Laser (LEONARDO® DUAL 45): a Pilot Study
Background: Ovarian endometrioma is the most common manifestation of endometriosis and is associated with chronic pelvic pain, infertility, and reduced ovarian reserve. Surgical treatment options include cystectomy and ablative techniques. Recent evidence suggests that ablative approaches may better preserve ovarian reserve compared with cystectomy while maintaining comparable recurrence and pregnancy rates. However, limited histological data are available regarding the depth of tissue damage induced by ablative techniques and their ability to completely eradicate endometriotic tissue.
Objective: This pilot study aims to histologically evaluate the effects of ex vivo ovarian endometrioma ablation using the LEONARDO® DUAL 45 dual-wavelength diode laser (980 nm and 1470 nm). The study will assess the completeness of endometriotic tissue ablation, the depth of laser-induced necrosis within the endometrioma pseudocapsule, and the extent of thermal injury to the surrounding ovarian tissue.
Methods: Adult women undergoing laparoscopic surgery for unilateral or bilateral ovarian endometriomas ≥3 cm will be prospectively enrolled. Surgical treatment will consist of cystectomy in reproductive-age women and adnexectomy in selected peri- or postmenopausal women according to routine clinical practice. After surgical excision, ex vivo samples of the internal endometrioma wall will undergo laser ablation using two different laser settings. Histological examination will evaluate residual endometrial glands and stroma, depth of necrosis, and thermal damage to adjacent ovarian tissue. Clinical, surgical, and pathological data will also be collected.
Study Design: Prospective, observational, pilot study involving a medical device. Approximately 30 patients will be enrolled, generating multiple histological specimens for analysis. The study is designed to provide preliminary evidence regarding the histological efficacy and tissue effects of dual-wavelength diode laser ablation of ovarian endometriomas.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Giorgia Gaia
- Номер телефона: +393384406299
- Электронная почта: giorgia.gaia@policlinicogemelli.it
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Female participants aged 18 years or older
- Ultrasound diagnosis of at least one unilateral or bilateral ovarian endometrioma measuring ≥3 cm in maximum diameter
- Scheduled for laparoscopic surgery (cystectomy or adnexectomy)
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Suspected ovarian malignancy based on preoperative clinical or imaging evaluation
- Presence of concomitant pelvic disease requiring complex surgical management or potentially interfering with histological assessment (e.g., pelvic inflammatory disease)
- Medical conditions contraindicating laparoscopic surgery
- Inability or unwillingness to provide written informed consent
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Complete histological ablation of endometriotic tissue
Временное ограничение: Immediately after surgery, at histological examination of ex vivo surgical specimens.
|
Histological absence of residual viable endometrial glands and stroma in ovarian endometrioma tissue following ex vivo ablation with the LEONARDO® DUAL 45 dual-wavelength diode laser.
|
Immediately after surgery, at histological examination of ex vivo surgical specimens.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Extension of laser-induced fibrosis/necrosis through the endometrioma pseudocapsule
Временное ограничение: Immediately after surgery, at histological examination of ex vivo surgical specimens.
|
Presence or absence of fibrosis and/or necrosis on the outer surface of the ovarian endometrioma pseudocapsule following ex vivo diode laser ablation.
|
Immediately after surgery, at histological examination of ex vivo surgical specimens.
|
|
Depth of thermal injury to healthy ovarian parenchyma
Временное ограничение: Immediately after surgery, at histological examination of ex vivo surgical specimens.
|
Depth of laser-induced thermal damage in the underlying healthy ovarian tissue, measured histologically in millimeters (mm) in specimens obtained from adnexectomy procedures.
|
Immediately after surgery, at histological examination of ex vivo surgical specimens.
|
|
Association between laser emission settings and histological tissue effects
Временное ограничение: Immediately after surgery, at histological examination of ex vivo surgical specimens.
|
Comparison of histological tissue effects induced by two diode laser emission settings (20 W, 980/1470 nm versus 15 W, 1470 nm), including necrosis depth and completeness of tissue ablation.
|
Immediately after surgery, at histological examination of ex vivo surgical specimens.
|
Соавторы и исследователи
Следователи
- Главный следователь: Giorgia Gaia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 27370
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.
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