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Идёт набор NCT06879912

A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot

— Наблюдательное Hernia, Inguinal Hernia, Ventral Colorectal Thoracic

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hernia, Inguinal, Hernia, Ventral, Colorectal, Thoracic. Базовые параметры: от 22 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
США
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

A Prospective, Post-Market Study to Evaluate the Clinical Utility of the Force Feedback Instruments in RAS Procedures Using the da Vinci 5 Surgical System

Обзор

The goal of this observational study is to understand the utility of force feedback instruments in surgeries that are done using the da Vinci 5 robot.

Первичные конечные точки

  • To assess the force imparted on the tissue by force feedback instruments. [Срок оценки: Intra-operative]
Вторичные конечные точки (1)
  • To evaluate the utility of force feedback instruments during specific procedural steps or tasks. [Срок оценки: Post-operative prior to discharge]

Критерии участия

Pre-Operative Inclusion Criteria:

  • Age 22 years or older
  • ASA ≤ 3
  • The clinical decision has been made to perform multi-port robotic assisted surgery with da Vinci 5 with Force Feedback instruments for the study specified procedure as primary procedure prior to enrollment in the study
  • Subject or a legally authorized representative is able to provide written informed consent using the study informed consent form prior to the study
  • Subject is willing and able to comply with the study protocol requirements including follow up schedule

Pre-operative Exclusion Criteria:

  • Subject receiving an emergent procedure
  • Subject planned to undergo major concomitant surgery for the treatment of a different medical condition than was originally planned
  • Subject with previous ipsilateral surgery (open, endoscopic or robotic) with the same surgical indication
  • Subject with past or ongoing medical conditions (for example: inflammatory bowel disease) which, in the judgment of the Investigator, puts them at high risk for surgery and not appropriate for the study
  • Subject is pregnant or suspected to be pregnant or breastfeeding
  • Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data
  • Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months
  • Subject belongs to a vulnerable population.
  • Subject is contraindicated for anesthesia or surgery.
  • Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for the treatment of the cancer to be resected within the past 6 months

Intra-operative Exclusion Criteria

  • Subject with hemodynamic or respiratory instability, which precludes the Investigator from performing the RAS.
  • Subject in whom inadequate visualization makes a minimally invasive approach not feasible, as determined from the investigator assessment prior to docking the robot.
  • Subject with adhesions, scarring and disease status in the body which in the opinion of the investigator limits the ability to perform the minimally invasive procedure.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 5 центров
  • University of Miami — Miami
  • Northeast Georgia Medical Center, Inc — Gainesville
  • Northwestern Memorial Healthcare — Chicago
  • Ohio State University — Columbus
  • St. David's Healthcare — Austin

Идентификаторы

NCT: NCT06879912 · ISI-dV5-MP-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗