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Идёт набор NCT07081828

The Asensus Paediatric Robotic Registry

— Наблюдательное Surgery Surgery in Early Childhood

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Surgery.
Кому может быть актуально
Состояния в реестре: Surgery, Surgery in Early Childhood. Базовые параметры: до 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Asensus Paediatric Registry of Robotic-Assisted Endoscopic Procedures in Urology, Gynaecology, and General Surgery

Обзор

An open-label, observational, paediatric registry trial in which participating centers enroll subjects who had or will have a laparoscopically-assisted surgery using the Senhance Surgical System.

Подробное описание

This is a prospective and retrospective, multi-center, observational registry study evaluating the use of the Senhance Surgical System in paediatric patients undergoing laparoscopically-assisted surgery. The trial is open-label and designed to collect both historical and prospective data from participating centers. Paediatric subjects who have undergone or will undergo procedures with the Senhance Surgical System will be enrolled. The primary purpose for this study is to assess safety outcomes. Secondary endpoints include length of hospital stay, procedural information, and patient-reported outcomes.

Вмешательства

  • Устройство Surgery
    Patients who undergo surgery utilising the Senhance Surgical System.

Первичные конечные точки

  • Adverse Event [Срок оценки: Index surgery to 30 days postoperative]
  • Procedure-related severe adverse event [Срок оценки: Index surgery to 30 days post-operative]
Вторичные конечные точки (5)
  • Length of Stay [Срок оценки: From day of index procedure to hospital discharge, up to 2 weeks]
  • Conversion to unplanned open surgery [Срок оценки: Intraoperative (during index surgical procedure)]
  • COMFORT-B scale for assessing pain in pediatric patients aged 0 to less than 2 years of age [Срок оценки: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.]
  • Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale for children aged 2 years to less than 7 years of age. [Срок оценки: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.]
  • Numerical Rating Scale (NRS) for assessing pain in patients aged 7 years to less than 18 years of age. [Срок оценки: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.]

Критерии участия

Критерии включения

  • < 18 years of age
  • Body weight > 10 kg
  • Indication for a potential robot-assisted operation
  • Expected survival of > 3 months

Критерии исключения

  • Subjects requiring surgery on the heart or greater vessels.
  • Subjects for whom a laparoscopic approach and endoscopic approach in the thoracic area is not appropriate.
  • Anaesthetic contraindications, children with pacemakers or other implants for which electrosurgery must be avoided, children with cancer, parents who prefer to proceed with classical or manual laparoscopic surgery.
  • Subjects pregnant over the second trimester of pregnancy.
  • Parents or children with insufficient understanding of the site's local language (e.g. Dutch, German) or English language.
  • Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters due to which an endoscopic or laparoscopic surgical technique is contraindicated.
  • Subjects who would require an intervention to the upper mediastinum or to the upper pleural cavity regions as referred in the Senhance Surgical System User Manual (UM-001-00035\_CE).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Dr. von Hauner Children's Hospital Clinic of the University of Munich — München

Публикации

  • Killaars REM, Visschers RGJ, Cakir H, Dinjens DJA, Widmann DL, Friedrich H, Muensterer O, van Gemert WG, Goedeke J; MiniTrust Collaborative Study Group. Robotic-assisted endoscopic procedures in paediatric urology, gynaecology and general surgery: protocol for a multicenter observational registry study (MiniTrust study). BMJ Open. 2026 Mar 26;16(3):e110106. doi: 10.1136/bmjopen-2025-110106. PMID 41887639

Идентификаторы

NCT: NCT07081828 · miniTRUST

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗